For Brian Meissner, the sore throat and fever he experienced in January when he became infected with COVID-19 were harbingers of a host of health issues to come.

Meissner, a 36-year-old resident of Chiba Prefecture, says he had received two COVID vaccine shots and was waiting for a third when he fell ill. After going to a local drive-in clinic and testing positive for the coronavirus, he was prescribed molnupiravir, an oral medication approved for COVID treatment, and was told to rest at home for two weeks.

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Long COVID takes toll as Japan patients seek answers - The Japan Times

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Alicia Morgans: Hi, I'm so excited to be here today at APCCC 2022, where I have two wonderful friends and colleagues to discuss PARP combination therapy, and thinking about how that may be, or may not quite be, ready for primetime use in clinical practice. I have Dr. Maha Hussain, who is a Professor of Medicine at Northwestern University and, of course, a GU Medical Oncologist, and Dr. Fred Saad, who is a Professor of Urology and the chair of that department at the University of Montreal. Thank you both so much for being here today.

Maha Hussain: Thank You.

Fred Saad: It's A pleasure.

Alicia Morgans: Wonderful. I know you're both very involved in these PARP trials and in PARP combinations, and I'd love to hear your thoughts. Why don't we start just briefly recapping some of the data Maha, would you mind sharing with us some of the data and then we can let Fred take the other study?

Maha Hussain: Absolutely. I think, from my end, I began with my interest in the PARP, probably around 2010 or so, when there was data coming up regarding the potential synergistic effect of targeting the PARP pathway and the androgen receptor. And so we designed clinical trials that were part of the Stand Up To Cancer at the time, which suggested some interesting trends, and then subsequently, of course, the definitive trials were done with PROfound, again, demonstrating that in the second or post-second line therapies in heavily pretreated patients preselected for DNA damage response defects, these patients benefited from PARP inhibition. One thing that's clear, is not all pathway elements or alterations are equal, and pretty much, a lot of the data positivity is in the BRCA2, however, there is certainly benefits in other HRR mutation areas.

So I do think that we have come a long way and we're looking at combination treatments, and of course, you've seen the data that was presented ASCO GU in the front-line setting. And I would say the data is very interesting, but there are a lot of subtleties that we need to go through, basically.

Alicia Morgans: Absolutely. And, Fred, would you mind just sharing a recap of the MAGNITUDE and PROpel trials, which are really the studies that looked at these combinations presented at GU ASCO 2022?

Fred Saad: Yeah. It was really a lot of fun being able to present the data for the first time, and it's really building on, on Maha's work on PARP inhibition and with the olaparib and the PROfound study that Maha led. Clearly, patients who have these mutations do very well when they've failed an AR-targeted therapy. And these are later lines of therapies, but even from PROfound, I think we learned that if you start earlier in these patients, they do better than delaying, because the trial allowed crossover. And patients who crossed over, didn't come close to doing as well as the patients who started earlier.

So taking that approach of saying, "Well, maybe we need to start, at the time, a first-line mCRPC," And taking into consideration some preclinical evidence that if you combine a PARP inhibitor with an AR-targeted therapy, there might be potential for synergistic effects that might lead to even better outcome. And obviously, I think we would all be convinced that patients who harbor BRCA mutations and maybe other HRR mutations would benefit from earlier introduction of these therapies.

The phase II study showed that, whether or not you had mutations, it looked like you can get benefit. It was only 140 patients, but they looked like they had benefit, and we published that a couple of years ago.

So, the PROpel study really used the strategy of saying, "Let's take all-comers with first line mCRPC who have not yet been exposed to novel hormonals, especially abiraterone, which was the backbone of the study." So, everybody in the study of 800 patients got abiraterone, which I think all of us would agree is the standard of care, or one of the standard of cares, for first-line mCRPC, and half got olaparib over and above the abiraterone. The first results were the primary endpoint of rPFS, which showed a very significant improvement in rPFS of about 8 months and a 34% reduction in progression or death. So, almost the same results as we saw with abiraterone against a pure placebo several years ago. So that was very insightful, that we were able to do better than the standard of care for now, at least in terms of rPFS.

And then in the subgroups, every subgroup appeared to gain benefit from the combination over the mono-therapeutic approach. And this included patients who had had docetaxel in the hormone-sensitive setting and, importantly, did well, even in patients without HRR mutations, which was almost 70% of the patients. Almost 30% did harbor mutations. So this is our first prospective study unselected that tells us that it's somewhere in between 25% and 30% of patients harbor mutations, of which the minority were BRCA. And those patients, obviously, it even looks like they're doing even better than the ones that are not mutated, but importantly, the non-mutated look like they were getting benefit, at least in terms of rPFS, with hazard ratios that are respectable, and we're still waiting for the updated results from that trial.

Alicia Morgans: Absolutely. And the MAGNITUDE study was interesting, looking at niraparib and abiraterone also in the first-line mCRPC setting. But in this case, the benefit was really confirmed in those patients who had BRCA1/BRCA2, but did not seem to be conferred to those patients who did not have those DNA repair defect alterations, which was interesting. So, really, those patients who had the DNA repair defect alterations, all of those included in the study, versus those who did not, those patients seemed to benefit

Fred Saad: Importantly, it was really the BRCA that was driving all the positive results, because the non-BRCA patients didn't appear to be getting much benefit. Obviously, subgroups and all the rest. And, really, the primary endpoint was the BRCA-mutated patients, where a lot of the data is supportive for looking at those patients in earlier introduction. So I think two positive studies, at least for patients that are mutated. The question that's going to be, I guess, debatable or questionable is, are we ready for the prime-time, like you asked upfront?

Alicia Morgans: Yes. And especially in that population that does not have the DNA repair defects, what's the truth there? Is it the combination allowing that sensitivity that we think may be conferred with the combination? Or is there something else going on? Is it perhaps just something that, if we follow them longer, we won't actually see that benefit? Dr. Hussain, what do you think about the non-mutated, the DNA repair defect-negative patients?

Maha Hussain: I question the value there. And this goes back to the days where we did the combination trial that was, again, part of the Stand Up To Cancer effort. Granted, not everybody got the genomic testing, because it's just the patients that had the availability of tissue. But what we saw in that trial, and just as a reminder for the audience, this was a trial that basically looked at combination abiraterone plus veliparib versus abiraterone alone in front-line metastatic castration-resistant disease. And then a large percentage of the patients who were recruited to this study, in fact, did have tissue available, or some of them underwent biopsy of metastatic disease for the purposes of this study.

What the data showed, basically, is that, again, overall, there was no advantage to the addition of veliparib with regard to the primary endpoint of this study. But when we looked at the breakdown again, this is post-hoc analysis, just for clarity, what was clear is this, is patients who had the HRR mutations or the DNA repair defects did better no matter what. So, if they were in the combo arm or the single-agent arm, did better than the patients who had intact tumors. And this is where comes up my bias, I guess, with the data from the PROpel trial. There's a lot of subtleties, of course, and different drugs are different.

I think that the another trial that we are reporting at ASCO this year looked at, again, the issue of combination versus single agent in both. So none of the phase III trials, even the control arms have always been the AR inhibitor. In our trial, again, albeit phase II trial, actually, it's AR inhibitor, PARP inhibitor, versus combination. And there's clearly trends. The issues is going to be is this. Is the sequential therapy.

That's where I think it's going to be important from both trials, PROpel and MAGNITUDE to actually see, if you have sequential therapy and people do just as well for overall survival, do you really need to subject them to the added physical, monetary, whatever cost of combination upfront versus not? My gut feeling is, like anything else, combination therapy tends to do better. So if I were to guess, I think it's going to be, at least in the HRR positive patients, there's going to be the trend of benefit there. But we'll have to see what the data looks like.

Alicia Morgans: Absolutely.

Fred Saad: Yeah. And your own PROfound, I think, would suggest that earlier appears to be better.

Maha Hussain: Yes. Yeah, yeah.

Fred Saad: So, the question is, do you need to combine? And I think for patients starting mCRPC, we need to give them the best standard of care.

Maha Hussain: Yes.

Fred Saad: Now, whether that's best standard care started in hormone-sensitive is a whole other question. And that's where the field is going.

Maha Hussain: Yes, I agree. I agree.

Fred Saad: And this is going to be the challenge in the future. How many mCRPC patients are going to not have been pre-exposed to NHTs in the past? But beyond HRR, and I think this is where we all, as a community, need to think, have we identified all the biomarkers of poor outcome? And we have biomarkers like chemotherapy in the hormone-sensitive setting, which might be growing over time. And these patients did really badly. They did as badly as the HRR-mutated patients in terms of how quickly they progress on Abi alone, and they did substantially better when they were combined to a PARP inhibitor.

We have the younger patients under 65. For some reason, they did exceptionally well with the combination compared to Abi alone. We have the patients who have visceral metastatic disease that don't do well on Abi alone that did substantially better in the combination. So I think we're going to all have to work on including, I don't think either of us would say we don't need to test genomic testing anymore. It's part of the equation of making a clear, informed, best approach for the individual.

Maha Hussain: Yes.

Alicia Morgans: Yeah.

Fred Saad: And, clearly, we won't be giving combination to everybody, but there are patients that come in and that I'm very concerned about. And I say, "These patients are not going to do well, and we need to do more than what we're doing today."

Maha Hussain: And I think what's going to confound things is the fact that you have the data from the triplets with darolutamide, the triplet with abiraterone in the hormone-sensitive space. And the question is, how does that paradigm shift? And of course there are trials in the hormone-sensitive space with PARP inhibitors and the issue, again, how does that impact things there?

I think the good problem, as I say, there are problems that are bad, there are problems that are good, the good problem is we have many choices for patients. There is a lot of investment in research in this patient population by comparison to even 10 years ago. So I do think that our job as the physicians is to actually go with what we think is the best process with regard to enhancing outcomes for patients, and clearly, quality of life and prolongation of life.

Alicia Morgans: Absolutely. And I know that both of you continue work in this space. I know, Maha, you're doing investigations into the basic biology to look for those unidentified drivers, because clinical features will only get us so far, but those expression profiles, those alterations that haven't been identified yet are in process. We're hoping Dr. Hussain can share those with us at some point in the near future. So, each of you, I'll give you a final word. Is combination therapy ready for prime-time in the clinic now? And if so, in whom? We'll give Maha the final word, so you get to answer first, Dr. Saad.

Fred Saad: I would say, yes, that it is ready for prime-time. The combination in first-line mCRPC. The low-hanging fruit are the patients with mutations, and I would go beyond BRCA, at least what we saw, but at the very least BRCA. But then I think the clinical parameters that we still don't understand why the biology of those parameters seem to indicate that the combination is better than simple abiraterone review. So I think we are ready for prime-time. I think it's going to be a question of selecting our patients that most need our help in doing better, because the reality is, many, many patients around the world are limited to first-line treatment and mCRPC, and don't go beyond that.

Alicia Morgans: Absolutely. Dr. Hussain.

Maha Hussain: I think I fully agree. I would just add to it, is that, pending the overall survival data based on the radiographic progression-free survival, I think the combination is, to me, clinically relevant, but I would say specifically in the patients who have the HRR mutations. So this is, if I were to offer it right now, I wouldn't offer it to all-comers. I would offer it to people who have the mutations. Again, pending the overall survival data.

If the overall survival data confirms the intermediate endpoint, so to speak, that would be great. The dilemma's going to be is if the overall survival data is no better. The question comes up is, how do you define risk benefit? And is sequential therapy going to be of value? And this is where our BRCA trial, again, not a phase III, small scale, but we're looking at sequential therapy crossing over and comparing front-line this versus that, and then crossing over. Will be interesting to see how that has resulted.

Alicia Morgans: Absolutely.

Maha Hussain: We're hoping to report it, hopefully, by the end of the year.

Alicia Morgans: Wonderful. Well, we will definitely catch up with you on that, and thank you both so much for sharing your thoughts on the PROpel and the MAGNITUDE data and how we think about that in clinical practice. It has truly been a pleasure.

Maha Hussain: Pleasure is ours, my dear. Thank you.

Alicia Morgans: Thank you.

Fred Saad: Thanks, Alicia.

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PARPi Combination Therapy Use in Clinical Practice - Ready for Prime-Time? - Maha Hussain and Fred Saad - UroToday

Recommendation and review posted by Bethany Smith

While in the United Kingdom (UK) for her masters degree in 2012, Pumla Nabacwa was referred to a fertility clinic for a certain procedure. As she waited at the reception for her turn to see the gynaecologist, she overheard two women (both aged about 35 years) talking about their struggles with infertility and how they had tried to conceive but in vain.

From the conversation, Pumla, then 28 years old, learnt that the women needed egg donors but the available ones were white. When it was her turn to see the gynaecologist, Pumla asked if she could donate her eggs.

She went through a series of tests and screening including blood work, physical and psychological health tests and after two days, she was contacted by the hospital. She had met all the criteria needed to donate and was asked to go back to the clinic at her convenience. The next day, she walked into the clinic and started the process that would last a month.

I had to put aside all my fears since my goal was to help those women and many like them that were struggling to have children. I was given hormone stimulating injections, with which I injected myself on the abdomen twice a day for 30 days and thereafter, the doctor harvested 27 eggs, she says, adding that three months later, she donated another 25 eggs.

According to Dr Edward Tamale Ssali, a gynaecologist at Womens Hospital International and Fertility Centre in Bukoto, Kampala, there are two types of donors.

One who is known to the recipient; most preferably a relative or friend or an anonymous person whose details are only known by the hospital. An anonymous donor is usually preferred in the African setting because this remains a secret between parents. In the West, the child has a right to know about the donation as soon as they turn 18 years.

Egg donation is a process in which a fertile woman donates an egg (oocyte), to another woman to help her conceive. The egg donors give eggs to a clinic for a recipient to be mixed with a partners sperm, or donor sperm, and used in assisted fertility treatment techniques such as In Vitro Fertilisation (IVF). The donor should be between 21 to 35 years of age.

The process starts with ones declaration of interest to donate the eggs. One must be willing to undergo several tests, starting with a background study where the doctor will ask questions about your family history.

The doctor will screen one for hepatitis, HIV, Sickle cell disease, hemophilia, sexually transmitted infections, chronic illnesses such as diabetes, mental health and many other diseases that can be transmitted to the child from the mother.

Dr Joseph Nsengiyumva, a gynaecologist at Bethany Womens Hospital in Kampala, says a baby girl at birth has about two million eggs but by puberty, they may have reduced to about 500. A hormonal test (ovary reserve test), before donation is also done to ensure you have more than enough eggs to donate.

In Uganda, you must have a letter from the LC1 chairman to track your criminal record, a national ID card for proof of your age, passport size photos and when all the criteria is met, the donor goes through pre-donation counselling. Then, one will sign a consent clearly stating that they are donating willingly.

I was given injections and give strict guidelines. I would self-inject after every 12 hours for a period of 30 days and would go to hospital for review twice a week. Here, an ultra sound scan would be used to see if the eggs are increasing in size and number, making them strong and viable, Pumla says.

The donor is also given fertility drugs that stimulate the ovaries to produce several eggs at once. During the donation cycle, donors stand risk of pregnancy before the eggs are retrieved. It is a good idea to avoid intercourse or use a barrier contraceptive, such as a condom.

During the cycle, the donor goes through frequent blood tests and ultrasound examinations to monitor their reactions to the medications. The hormonal stimulation process requires one to eat a healthy diet, although there are no food restrictions except for smoking and minimal alcohol consumption.

Pumla says there is a bit of discomfort since one suffers from bloating, swelling of the stomach and fluid retention due to the hormones although these stop after the eggs are harvested. On day 26, the doctor confirms the date of harvesting, which is an outpatient procedure that takes a few hours.

Dr Ssali says: Before the eggs are retrieved, the donor receives a final injection in preparation for the procedure and is put under sedation. A transvaginal ovarian aspiration is done to remove the eggs from the donors ovaries. An ultrasound probe is inserted into the vagina and a needle is used to remove the eggs from each follicle.

Eggs can also be harvested for women before they undergo chemotherapy, radiotherapy, those who have not found the right partners or are first focusing on career, frozen and made available when they need them. This, Dr Nsenyimva says, costs Shs5m.

Pumla donates her eggs free of charge. In the UK, I was given an allowance or a refund for transport costs to and from the hospital twice a week for review, and buying healthy foods.

Dr Nsengiymva says: You can only receive a donation of about Shs500,000 to Shs1m as a refund but not payment for the service. The service is paid for by the recipient who pays Shs1.5m and this is billed as part of the Shs18m to Shs22m (depending on the fertility clinic you go to) which is charged for In vitro fertilisation.

One must sign a contract stating that they do not get to know who the recipient is. In the UK, the donor remains anonymous and the child is only allowed to contact you after the age of 18. What I get to know is the number of my eggs that have been fertilised and have resulted in children, their date of birth and gender, says Pumla.

Her prayer is that at the right age, her children are told about the possibility of contacting her. She updates her information with the fertility centre every time she changes contact or residence so that she does not miss this opportunity.

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Do you have what it takes to be an egg donor? - Monitor

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If youve changed your supplement routine since the pandemic, youre not alone. According to a 2020 survey conducted by the Council for Responsible Nutrition (CRN), more than 43 percent of dietary supplement users have switched things up. Among those who updated their regimens, 91 percent reported increasing their supplement intake, either by adding new supplements, taking the same supplements more regularly, or upping their dose(s). Overall immune support and health and wellness benefits are cited as the top reasons.

But while supplements are often seen as a method to ensure you meet your daily nutritional needs, they can create problems if youre not careful. Like drugs, dietary supplements can affect the way your body functions, which can cause adverse effects in some people, according to an article published in the May 2022 issue of U.S. Pharmacist.

So, how do you know if youre overdoing it with the supplements? Read on to find out.

[In general], a supplement is something youre not getting enough of through food, says Rohit Moghe, PharmD, CDCES, a pharmacist with Trinity Health Mid-Atlantic in Philadelphia, and member of the American College of Lifestyle Medicine (ACLM).

To fill in these nutrient gaps, many people turn to gummies, capsules, powders, tinctures, and even saline solutions delivered via needle (known as IV therapy).

In the Dietary Supplement Health and Education Act of 1994, Congress defined supplements as products (other than tobacco) that are intended to supplement the diet, contains one or more dietary ingredients (including vitamins, minerals, herbs, botanicals, amino acids, or other substances) or their constituents, is intended to be taken by mouth as a pill, capsule, tablet, or liquid, and is labeled as a dietary supplement.

While many people are able to meet their nutrient needs through their diet, others may benefit from supplements. Particularly those who face a greater risk of nutrient deficiencies, including those with higher requirements (like children, adolescents, and pregnant and lactating women), those who struggle to absorb nutrients (like older adults, obese individuals, and people with chronic conditions), and those who follow a restrictive diet (like vegans and vegetarians), according to an article published in January 2018 article in Nutrients.

For example, a vitamin B12 supplement may be a good idea for older adults and people who follow a vegan or vegetarian diet. Vitamin B12 helps keep your blood and nerve cells healthy, and plays an important role in making DNA, per theNational Institutes of Health (NIH). Its found naturally in animal foods, which means vegans and vegetarians may not get enough through diet alone. Older adults may also be deficient in vitamin B12, because many dont have enough hydrochloric acid in their stomach to absorb it, according to the NIH. Therefore, both groups might benefit from a vitamin B12 supplement.

A common concern about supplements is that the industry, in general, is under-regulated. Unlike medications, supplements dont have to be approved by the U.S. Food and Drug Administration (FDA) before theyre sold or marketed.

New legislation, proposed by Senate Majority Whip Dick Durbin, a Democrat from Illinois, and Sen. Mike Braun, a Republican from Indiana, aims to improve the safety of dietary supplements by requiring manufacturers to list their products with the FDA under the Dietary Supplement Listing Act of 2022 a bipartisan initiative. The new legislation, which refers to the Dietary Supplement Health and Education Act of 1994, points out that in 1994 there were about 4,000 dietary supplements marketed in the United States, but the industry has boomed and now 50,000 to 80,000 products are available.

In the meantime, consumers cant be sure the supplements theyre taking are safe or effective.

Even if a supplement is considered generally safe, it may not be safe for you. Most vitamins and minerals have a risk of harm with dosages, and the risk is based on the individual nutrient and patient, says Ravi Tripathi, MD, medical director of critical care services for the Ross Heart Hospital at The Ohio State University Wexner Medical Center in Columbus. When it comes to supplements and risks, there is no one size that fits all, he says.

For example, people with an inherited condition called hemochromatosis have to be careful with iron supplements, as hemochromatosis causes toxic levels of iron to build up in their bodies, notes theNIH. And while most people dont get enough potassium even when diet and supplements are combined, according to theNIH, people with chronic kidney disease can develop abnormally high levels of potassium in their blood. This condition, known as hyperkalemia, can cause serious heart problems if left untreated, according to theNational Kidney Foundation.

Supplements can pose risks even in otherwise healthy people. According to theNIH, youre more likely to have side effects from dietary supplements if you take them at high doses or use many different supplements.

The symptoms from taking more supplementation that your body needs vary depending on the nutrient and the amount taken, and may only show up in blood tests. However, there are some physical signs to watch for. According to the May 2022U.S. Pharmacist article, general symptoms to look out for may include:

Why its good for you: Vitamin D (also known as the sunshine vitamin) helps your body absorb calcium, making it a key nutrient for bone health. Your body also needs vitamin D to carry messages between your brain and your body and fight off bacteria and viruses, according to the NIH.

Why you might be overdoing it: On the one hand, 40 percent of Americans are deficient in vitamin D, per blood tests (when serum levels are less than 50 nmol/L), according tofindings published in June 2018 in Cureus. The reason? Most of us arent getting enough sunlight exposure, notes the NIH. Taking a vitamin D supplement may help and the CRN survey shows this supplement is becoming more popular but its important to watch your dosage to ensure you dont get more than 100 micrograms (mcg) a day. According to the NIH, overdosing is almost always caused by taking supplements, as opposed to sunlight exposure or eating vitamin Drich foods.

Risks: Very high levels of vitamin D can cause nausea, vomiting, muscle weakness, pain, loss of appetite, dehydration, and kidney stones, per the NIH.

Why its good for you: Iron is a mineral your body needs to make hemoglobin, a protein in red blood cells that carries oxygen throughout your body, according to theNIH. It also helps your body make hormones.

Why you might be overdoing it: Iron supplements are often recommended for younger women to help offset iron lost during menstruation. But according to theCleveland Clinic, many women continue to take supplements containing iron after menopause, when menstruation stops and iron needs decrease.

Risks: Getting too much iron can cause gastrointestinal (GI) symptoms like constipation, nausea, vomiting, abdominal pain, and diarrhea, per the NIH. Overdosing on iron can also lead to inflammation of the stomach lining and ulcers. Although rare, extremely high doses of iron (in the hundreds or thousands of milligrams) can even cause organ failure, coma, convulsions, and death, according to the NIH.

Why its good for you: According to theNIH, vitamin A is important for vision, immune health, reproduction, growth, and development.

Why you might be overdoing it: Its pretty easy for most people to score plenty of vitamin A. If you eat cereal for breakfast and carrots or sweet potatoes at lunch, and then pop a supplement for eye health, youve probably gone over the recommended amount, says the Cleveland Clinic.

Risks: High levels of vitamin A can cause severe headaches, blurred vision, nausea, dizziness, muscle aches, and coordination issues, notes the NIH.

Why its good for you: Vitamin C, also known as ascorbic acid, acts as an antioxidant, helping to protect your body from free radical damage. According to theNIH, your body also needs vitamin C to make collagen, a protein thats important for wound healing.

Why you might be overdoing it: The CRN survey found that vitamin C supplements have seen a big boost since the pandemic. However, most people can get enough vitamin C through food. In fact, 1 cup of strawberries, chopped red pepper, or broccoli will provide the daily amount needed, per Mayo Clinic.

Risks: Taking too much vitamin C can cause diarrhea, nausea, and stomach cramps, according to Mayo Clinic. Vitamin C supplements may also interact with cancer treatments like chemotherapy and radiation therapy, per the NIH. In addition, a past study found that men who took vitamin C supplements had a higher risk for developing kidney stones.

Why its good for you: Calcium is a mineral that builds and maintains strong bones. It also plays a role in nerve function, circulation, and hormone release, according to theNIH.

Why you might be overdoing it: You may be tempted to load up on calcium supplements to protect your bones, but according to theCleveland Clinic, its surprisingly easy to overdo it. Especially if youre already getting calcium from your food.

Risks: Excess calcium has been linked to constipation, kidney stones, kidney failure, heart problems, and cognitive issues, according to the Cleveland Clinic.

Experts often recommend speaking with your doctor before trying a supplement. Unfortunately, many physicians and nurse practitioners arent as knowledgeable in this area. I find many [healthcare professionals] are grossly unprepared to answer their patients questions, and they wind up telling them that supplements are a waste of money, when maybe theres a product that may actually work for your intended use, Dr. Moghe says.

If youre interested in adding a supplement to your diet, Moghe suggests talking with a physician trained in integrative medicine or nutritional medicine, a pharmacist, naturopath, or registered dietitian. You can check the directories of the National Board of Physician Nutrition Specialists and the American Board of Physician Specialties to find a healthcare professional who works for your needs.

Simple blood tests can reveal if youre deficient in specific nutrients, but the routine blood work at your annual physical doesnt typically include these tests, although some nutritional deficiencies can produce changes on these labs, according toRush University. Youll have to request these blood tests when you visit your doctor. A physician trained in integrative medicine and/or nutritional medicine, a pharmacist, naturopath, or registered dietitian may be able to offer suggestions and a tailored approach to getting the right levels of nutrients for you, and explore whether it makes sense to test for specific vitamin deficiencies given your unique lifestyle, diet, and health.

Read more:
Can You Take Too Many Supplements? - Everyday Health

Recommendation and review posted by Bethany Smith

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Data show MammaPrint is the first and most comprehensive FDA-cleared test for early breast cancer resulting in the ability to identify women who may be over- or under-treated if treatment decisions relied on the 21-gene assay

FLEX Trial continues to support the discovery and development of novel genomic profiles, bringing precision oncology into the clinic to improve and redefine breast cancer management

IRVINE, Calif. & AMSTERDAM--(BUSINESS WIRE)--Agendia, Inc., a commercial-stage company focused on improving outcomes for breast cancer patients worldwide by providing physicians and patients with next-generation diagnostic and information solutions to inform optimized treatment decision-making, today announced it will present seven posters derived from the companys FLEX Trial, the real-world, multicenter, prospective, observational breast cancer study at the American Society of Clinical Oncology Annual Meeting (ASCO) 2022.

One of Agendias posters, selected for the oral discussion session, titled Whole transcriptomic analysis of HR+ breast cancer in Black women classified as basal-type by BluePrint [Reid, S., et al.], will present findings from a racially-diverse cohort and resulting transcriptomic analyses suggesting hormone receptor-positive (HR+)/Basal tumors are biologically similar to triple-negative breast cancer (TNBC) tumors, regardless of race, demonstrating the importance of subtyping a tumors biology to determine optimal treatment course. BluePrint also identified racial disparities in the proportion of HR+/Basal tumors, showing a near doubling of such tumors among Black women, underscoring the need for diverse representation in clinical trials, a hallmark of the FLEX Trial.

Leveraging the BluePrint assay, we are able to uncover new gene expression insights for HR+/Basal breast cancer tumors, which traditionally are more aggressive, higher grade, and disproportionally impact Black women compared to White women, said Sonya Reid, MD, MPH, Department of Medicine, Vanderbilt University Medical Center. The FLEX Trials robust collection of diverse patient genomic profiles uniquely allows for sub-studies analyses like these to take place, helping researchers better support their patients from all racial and ethnic backgrounds with further classification of breast cancer tumors.

These data build on findings presented at San Antonio Breast Cancer Symposium 2021, also authored by Dr. Reid, that showed MammaPrint and BluePrint more robustly identify differences in more aggressive breast cancers in Black and White women beyond clinical factors, highlighting the fundamental importance of genomic classification and personalized treatment planning.

In addition, Agendia will present several sub-studies highlighting the FLEX Trials approach to cancer research by accelerating impactful data generation, aimed at redefining cancer care. The company believes this patient-centric design and national network of participating sites backed by Agendia will allow its investigator-initiated sub-studies to produce important results with the potential to drive science forward, like those being shared at ASCO 2022:

These new findings presented at ASCO 2022 show the breadth of the FLEX research platform to identify and evaluate the many different complexities of a breast cancer biology at diagnosis that may facilitate more precise and individualized treatment recommendations, said William Audeh, MD, Chief Medical Officer at Agendia. Agendias commitment to expanding our understanding of breast cancer to improve outcomes for women with breast cancer is astounding, exemplified by the FLEX Real World Evidence Trial. FLEX has the significant potential to broaden the application of genomic information through assays such as MammaPrint, BluePrint, and new proprietary Agendia signatures, which could lead to practice-changing models within breast cancer care aimed at improved outcomes for women with breast cancer.

Agendia will be sharing updates throughout the conference on its Twitter, Facebook and LinkedIn pages.

About Agendia

Agendia is a mission-driven, commercial stage company focused on enabling optimized decision-making by providing physicians with next-generation diagnostic and information solutions that can be used to help improve outcomes for breast cancer patients worldwide. The company currently offers two commercially-available genomic profiling tests that help surgeons, oncologists and pathologists to personalize treatment for women at critical intervention points throughout their patient journey.

MammaPrint is a 70-gene prognostic test that, along with other clinicopathologic factors, determines a specific patients breast cancer recurrence risk. BluePrint is an 80-gene molecular subtyping test that identifies the underlying biology of an individual breast cancer to provide information about its behavior, long-term prognosis and potential response to systemic therapy. Together, MammaPrint and BluePrint provide a holistic view of the biology underlying an individual patients breast cancer, enabling physicians to objectively select the best treatment plan.

For more information on Agendias assays and ongoing trials, please visit http://www.agendia.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220605005052/en/

Terri ClevengerWestwicke/ICR Healthcare PRTel: 203.856.4326[emailprotected]

Source: Agendia, Inc.

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Agendia Presents Data from the FLEX Real World Evidence Trial in Seven Posters at ASCO 2022, Showcasing the Power of Its 30,000-Patient Breast Cancer...

Recommendation and review posted by Bethany Smith

Sitting atop each kidney and measuring only around two centimeters long, the adrenal glands are tiny but mighty. These glands produce steroid hormones, including those involved in stress response, blood pressure maintenance, and fertility. When their development goes awry, it can cause a life-threatening condition called primary adrenal insufficiency, also known as Addisons disease. Many of the genetics involved in this and other adrenal gland disorders remain unknown.

Research on adrenal glands has often relied on insights made using mouse models. Now, a new study led by the School of Veterinary Medicines Kotaro Sasaki, which examined the developmental origin of the glands in humans and nonhuman primates, finds key developmental differences. This new understanding may inform diagnostics and treatment for Addisons disease and other endocrine system disorders.

The work was published in the journal Science Advances.

While some genetic causes of primary adrenal insufficiency have been identified, the mechanism has remained poorly understood, says Sasaki. Our findings help in identifying genes involved in adrenal development and could lead to new targets for therapeutic intervention.

Sasakis investigations have centered around studied gonadal development, how cells become ovaries or testes, organs that, like the adrenal gland, release hormones. Given this background, the adrenal gland was a natural next focus, especially because it has a shared origin with the gonads. In their recent work, Sasaki and colleagues looked at some of the earliest developmental stages to see how precursor cells and tissues evolve to give rise to the adrenal gland.

Scientists have long known that both the gonads and adrenal gland develop from a tissue known as the coelomic epithelium (CE), which is present at an early stage of embryonic development. In mice, for example, this tissue develops into the adrenogonadal primordium, which later divides to form both the adrenal primordium and the gonadal progenitor. The adrenal primodium goes on to become the adrenal gland, and the gonadal progenitor develops into either ovaries or testes.

Using immunofluorescence and in situ hybridization analyses, in which markers enable scientists to track cells descendants, Sasaki and his team found that primate CE expressed different genes than mouse CE. Whereas mice expressed the WT1, GATA4, and NR5A1 genes within the adrenogonadal primordium, primates did not express GATA4 in a parallel stage of development, a surprise to the researchers.

Whats more, while one portion of the primate CE led to the gonadal precursor, the other developed into the adrenal gland precursors, a division that wasnt present in mice.

It takes place in a way thats totally different from the mouse, says Sasaki. It appears that the portion of the coelomic epithelium that gives rise to the gonads is spatially separated from the part that gives rise to the adrenal gland.

Single-cell sequencing further revealed different patterns of gene expression between the adrenal and gonadal cell lineages, as well as a clear divergence between humans and mice. Some of these differentially expressed genes, Sasaki notes, are likely important in the process of deriving adrenal or gonadal tissues from CE.

Certain genes, Sasaki says, could also be examined in the context of adrenal insufficiency.

Currently, people with Addisons disease are treated with a lifelong steroid replacement therapy, using synthetic hormones to substitute for those that their bodies cant make on their own. Its not a cure and comes with serious side effects, Sasaki says.

In future work, he and colleagues hope to lay the groundwork in the lab to generate the adrenal cortex, employing inducible pluripotent stem cells, cells derived from blood or skin that can be induced to become a variety of different cell types. With such an approach, they could coax the stem cells to follow the normal developmental pathway toward becoming adrenal tissue. While in its early stages, this could enable a cell-based therapy for primary adrenal insufficiency, ideally avoiding some of the drawbacks of hormone replacement therapy.

Were pursuing in vitro studies to continue mapping out a blueprint that could be applicable to humans, Sasaki says.

Kotaro Sasaki is an assistant professor in the Department of Biomedical Sciences at the University of Pennsylvania School of Veterinary Medicine.

Sasakis coauthors were Penn Vets Keren Cheng, Yasunari Seita, Taku Moriwaki, Yuka Sakata, and Young Sun Hwang; Kiwamu Noshiro, Hidemichi Watari, and Takeshi Umazume of Hokkaido University; Toshihiko Torigoe of Sapporo Medical University; Mitinori Saitou of Kyoto University; Hideaki Tsuchiya and Chizuru Iwatani of Shiga University of Medical Science; Masayoshi Hosaka of the Fukuzumi Obstetrics and Gynecology Hospital; and Toshihiro Ohkouchi of Ohkouchi Obstetrics and Gynecology Hospital.

Sasaki was corresponding author and Cheng, Seita, and Moriwaki were co-first authors of the work, which was supported in part by the Japanese Science and Technology Agency (grants JPMJCE1301 and JPMJER1104), Silicon Valley Community Foundation, and Good Ventures Foundation.

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Elucidating the developmental origin of life-sustaining adrenal glands | Penn Today - Penn Today

Recommendation and review posted by Bethany Smith

It is a rather exciting month for beauty addicts because May has showered many launches upon us. From makeup to skincare, this month is packed with newbies some exciting, some innovative that make for productive additions to your vanity. With transitional weather (cloudy and heatwaves in equal parts), most of these products help you survive the maddening climate too. So, what are you waiting for? Scroll down and meet the latest beauty picks that deserve a spot in your shelfie.

iS Clinical Active Peel System

Meet the all-new two-step peel system from iS Clinical that treats the skin in just two steps, in fact just two pads. While the first pad is more like a target-based treatment while the second one is more hydrating. The duo comprises ingredients like copper tripeptides, AHAs and BHAs from fruits and an enzyme complex that exfoliates, hydrates and rejuvenates the skin, endowing multidimensional benefits. Some of which include boosted collagen production, minimised pores and wrinkles and improved skin texture.

PS: This is perfect to replace your nighttime skincare routine. Do not use any other product besides these two steps, when indulging in them.

Nykaa SkinRX Vitamin C Day Moisturizer

Before you think about the fact the brand had just launched moisturisers a while back, heres the catch these ones are oil-free. Super appropriate for the current hot and humid weather, this lightweight, gel-based cream is quick-absorbing and delivers decent moisture. This variant with vit C is best-suited for mornings, to keep sun damage at bay.

Anastasia Beverly Hills Magic Touch Concealer

Looking for a new concealer that blends out like a dream? This creamy formula does exactly that without caking up, thanks to the watery texture that (still) very effectively conceals dark spots and blemishes plus neutralising any unevenness.

Nashi Argan Sun Oil

Let me tell you Nashi Argan does one of the best argan oils out there that gives your hair a hug of *intense* nourishment. One of the most efficacious argan oil to smoothen locks, the best-selling oil has now been launched in a limited edition variant with UV protection infused in it, making it all the more better for this scorching season.

Revlon Colorstay Satin Ink

Revlon is out with yet another classic liquid lip that ties comfort and colour in one formulation, without even compromising minutely on either. With a high colour pay-off, this lippie wears comfortably and avoids all kinds of cracking and drying, courtesy of black currant seed oil. The best part? The creamy, shiny finish also has longevity. Plus, its available in some delicious colours.

Manish Malhotra Lip Liner & Filler

We all love (and need) a good lip liner, periodt. Now, before you worry about the tugging, let me introduce you to these just-in lip liners that make lip contouring a fun and comfortable experience. You can go ahead and fill-in your lips with em too, after all, they contain argan oil and hyaluronic acid to prevent chapped lips whatsoever.

Simply Nam Clean Lashes Mascara

Want to elevate your mascara application experience and the final look of it? Enter this mascara that has a whipped liquid formula that lengthens the lashes impressively without causing any clumps. In spite of this, its smudge-proof and waterproof, making it a holy grail for everyday wear in summers. Dont worry about flakiness it doesnt vandalise the lashes, thanks to avocado and jojoba oil. Extra points for the wand, thats as unique as it is effective.

Daughter Earth Under Eye Serum

Combining traditional gems with modern-age ingredients, the homegrown super brand has launched a much-needed product, yet again with triphala (amala, haritaki and bibhitaki) and apple stem cells (extract derived from the cells). Other noteworthy ingredients include caffeine, aloe, cucumber, watermelon and bakuchiol that help firm, tighten and brighten the under eye skin. Trust the lotion-textured serum to provide firmer, smoother and more youthful-looking eyes by alleviating signs of ageing and fatigue.

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All Things Hot In The Beauty Space In The Month Of May | Femina.in - Femina

Recommendation and review posted by Bethany Smith

A market study Global examines the performance of theCryonics Technology2022. It encloses an in-depth analysis of the Cryonics Technology state and the competitive landscape globally. The Global Cryonics Technology can be obtained through the market details such as growth drivers, latest developments, Cryonics Technology business strategies, regional study, and future market status. The report also covers information including Plastic Additive industry latest opportunities and challenges along with the historical and Cryonics Technology future trends. It focuses on the Cryonics Technology dynamics that is constantly changing due to the technological advancements and socio-economic status.

Pivotal players studied in the Cryonics Technology report:

Praxair, Cellulis, Cryologics, Cryotherm, KrioRus, VWR, Thermo Fisher Scientific, Custom Biogenic Systems, Oregon Cryonics, Alcor Life Extension Foundation, Osiris Cryonics, Sigma-Aldrich, Southern Cryonics

Get free copy of the Cryonics Technology report 2022:https://www.mraccuracyreports.com/report-sample/380040

Recent market study Cryonics Technology analyses the crucial factors of the Cryonics Technology based on present industry situations, market demands, business strategies adopted by Cryonics Technology players and their growth scenario. This report isolates the Cryonics Technology based on the key players, Type, Application and Regions. First of all, Cryonics Technology report will offer deep knowledge of company profile, its basic products and specification, generated revenue, production cost, whom to contact. The report covers forecast and analysis of Cryonics Technology on global and regional level.

COVID-19 Impact Analysis:

In this report, the pre- and post-COVID impact on the market growth and development is well depicted for better understanding of the Cryonics Technology based on the financial and industrial analysis. The COVID epidemic has affected a number of Cryonics Technology is no challenge. However, the dominating players of the Global Cryonics Technology are adamant to adopt new strategies and look for new funding resources to overcome the rising obstacles in the market growth.

Access full Report Description,TOC, Table of Figure, Chart, etc.@https://www.mraccuracyreports.com/reportdetails/reportview/380040

Product types uploaded in the Cryonics Technology are:

Slow freezing, Vitrification, Ultra-rapid

Key applications of this report are:

Animal husbandry, Fishery science, Medical science, Preservation of microbiology culture, Conserving plant biodiversity

Geographic region of the Cryonics Technology includes:

North America Cryonics Technology(United States, North American country and Mexico),Europe Market(Germany, Plastic Additive France Market, UK, Russia and Italy),Asia-Pacific market (China, Plastic Additive Japan and Korea market, Asian nation and Southeast Asia),South America Plastic Additive Regions inludes(Brazil, Argentina, Republic of Colombia etc.),Plastic Additive Africa (Saudi Arabian Peninsula, UAE, Egypt, Nigeria and South Africa)

The Plastic Additive report provides the past, present and future Plastic Additive industry Size, trends and the forecast information related to the expected Plastic Additive sales revenue, growth, Plastic Additive demand and supply scenario. Furthermore, the opportunities and the threats to the development of Cryonics Technology forecast period from 2022 to 2029.

Please click here today to buy full report @https://www.mraccuracyreports.com/checkout/380040

Further, the Plastic Additive report gives information on the company profile, market share and contact details along with value chain analysis of Plastic Additive industry, Plastic Additive industry rules and methodologies, circumstances driving the growth of the Cryonics Technology and compulsion blocking the growth. Cryonics Technology development scope and various business strategies are also mentioned in this report.

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Cryonics Technology Market Size & Analysis By 2022 -2029 -Praxair, Cellulis, Cryologics, Cryotherm, KrioRus, VWR, Thermo Fisher Scientific, Custom...

Recommendation and review posted by Bethany Smith

This is not a piece I was dying to write. Its about death. The great equalizer.

The reason I bring up the subject today is that I read a piece recently that scientists are looking seriously at ways to keep us alive forever. No more wakes. No more inflated obituaries. No more people saying nice things to the family about us they really didnt mean. No more squabbling over who gets what in the estate.

Some deep-pocketed moguls seem to think there might be some big bucks in the effort. Big bucks, as in an estimated $610 billion by 2025. According to my abacus, thats two-and-a-half years from now. This tells me that we must be worth more alive than dead. Sorry about that, estate planners.

Heavy hitters like Paul Thiel, co-founder of Pay Pal and Jeff Bezos, Amazons chairman plus whoever is running Google these days are all funding initiatives to figure out a way to keep us and them, I would assume from kicking the bucket. The ideas range from rejuvenating cells to hacking the little boogers in order to recode them. If some nerdy kid locked away in his bedroom can hack my computer, how hard can hacking a cell be?

At a recent conference at the London Institute for Mathematical Sciences which I was unable to attend because it occurred the same week I had scheduled to rearrange my sock drawer, director Thomas Fink told a Washington Post reporter that life could be engineered to live longer if we could figure out why we age in the first place. Scientists agree that all organisms degrade over time and eventually break down. That is probably why my knees ache.

Forrest Sheldon, an associate at the institute, thinks that if the aging process is a mechanism inside the cell controlled by a transcription program, we might be able to influence it. Ill take his word for it because I have no idea what he is talking about.

This isnt the only effort at trying to figure out a way to help us achieve immortality which I will say modestly that I think I have already managed to do, thanks to my witty and thought-provoking columns. (Pause for applause.)

There is cryonics where they freeze your body, hoping to figure out how to thaw you out which seems still to be a bit of a problem. And then there is something called mind-loading which involves scanning the brain accurately enough to copy it to a computer in digital form. The computer would then supposedly be able to experience feelings and have a conscience. What it would not be able to do is write witty and thought-provoking columns which, by the way, doesnt require a conscience.

Searching for eternal life on this earth is nothing new. It has been going on for eons and to no avail. Remember Ponce de Leon who came to Florida supposedly looking for the Fountain of Youth? All he found was water that smells like rotten eggs and a tourism industry.

The big question that must be asked is do you really want to live forever? That means if you can, so can a nutcase like Vladimir Putin. And that little fat guy with the bad haircut who runs North Korea. And the Supreme Whoever in Iran that hates Israel and wont let women ride bicycles. Not to mention the woke crowd, Cancel culturists and robocallers.

On the other hand, I would have humor-impaired wingnuts on both ends of the political spectrum to gig into all eternity as well as more tut-tut special interest groups than a yard dog has fleas, assuring me of an endless supply of witty and thought-provoking columns and further immortality. Not to mention a bunch of cranky emails.

I could paint forever and eat banana pudding forever and avoid broccoli forever, hoping the stuff couldnt get its cells hacked and might disappear forever. I could bleed red and black and never run dry and watch You-Know-Where Institute of Technology win three games a year into perpetuity.

Alas, scientists admit all of this is a long way off and might not even happen not the three wins a year for YKWIT, thats a given Im talking about staying alive forever. Evidently, hacking rejuvenated cells isnt as easy as it sounds. Rats.

I guess I will just forget all the science talk and get back to churning out witty and thought-provoking columns. After all, there is more than one way to be immortal.

Dick Yarbrough is a longtime Georgia resident and former public relations executive. Reach him at dick@dickyarbrough.com; at P.O. Box 725373, Atlanta, Georgia 31139; or on Facebook at http://www.facebook.com/dickyarb.

Read more here:
Dick Yarbrough: Who needs to live forever to be immortal? - Daily Citizen

Recommendation and review posted by Bethany Smith

23 May 2022

Male breast cancer accounts for around one percent of breast cancer cases in the UK and a newstudy suggests that men with infertility are twice as likely to develop it.

There is little awareness of the condition due to its rarity. Men who have it are often older at first presentation than women with breast cancer, and they haveless favourable outcomes than women. Researchers from the Institute of Cancer Research, London have recently published the results of their breast cancer in men casecontrol study.

'Our study suggests that infertile men may be twice as likely as those without fertility issues to develop breast cancer. The reasons behind this association are unclear, and there is a need to investigate the fundamental role of male fertility hormones on the risk of breast cancer in men. We hope this could lead to insights into the underlying causes of male, and possibly even female, breast cancer', said Dr Michael Jones, study senior author and staff scientist in genetics and epidemiology at the Institute of Cancer Research.

Nearly two thousand men from England and Wales who had been diagnosed with breast cancer between 2005-2017, and 1597 controls, were included in the study recently published in the journal Breast Cancer Research. They took part in interviews with a nurse where they provided information on whether or not they had children or had ever sought fertility treatment. They also provided a blood or saliva sample.

Analysis showed men who reported they had been diagnosed as having infertility had double the odds of developing breast cancer when compared with those without fertility issues. Furthermore, men without offspring had 50 percent increased odds of developing breast cancer, and this difference remained significant even if restricting the analysis to married men alone.

Researchers did not look at reasons for the link but suggested that hormones could play a role, and there is already some understanding that testicular problems that could lead to infertility could also affect hormonal production.

Dave, a former police officer from Bristol, was diagnosed with breast cancer in 2015 and said: 'My mother died from ovarian cancer when she was 68-years-old, and I knew there was a link between ovarian and breast cancer, but generally little is known about male breast cancer. People will say 'I didn't realise men could get that' and to be honest, I didn't think I would ever get it!'

'It's really interesting that if you're affected by fertility issues, you could be more likely to be affected by breast cancer. I'm lucky that I haven't been impacted by fertility problems, but it's important scientists build on Breast Cancer Now's research as it could help to find out what causes some male breast cancers and one day even lead to developing new treatments.'

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Men with infertility could have double the risk of breast cancer - BioNews

Recommendation and review posted by Bethany Smith

This kind of first-degree offspring is extraordinary, only having been cited in royal families of the past headed by god-kings such as the Egyptian pharaohs seeking to maintain a pure dynastic bloodline. (It is known, for instance, that Akhenaten married his eldest daughter, Meritaten, and much later, Ptolemy II married his sister, Arsinoe II hence his nickname, "Philadelphus" or "sibling loving.") It has been suggested that this Neolithic elite may have claimed to possess divine powers to ensure the continuity of agricultural cycles by keeping the Sun's movements going.

The findings support the notion that these Neolithic communities were socially stratified and that the massive stone structures were used to bury transgenerational patrilineal members of these clans. Perhaps equally interesting is the fact that in one case relatives were separated by up to 12 generations, pointing to an unusual stability through time of both the funerary tradition and the stratified society where they lived.

We have seen several case studies of past inequality correlating funerary archaeology with genetics that might no longer apply today, where legal regulations (and also the exponential increase of cremations) represent a certain degree of standardisation in funeral practices. Nevertheless, an opposite trend could shape thefuture of the archaeology of death: the trend toward personalised coffins, unconventional funerary memorials, and special grave goods. One way or another, mortuary archaeology will always be an important subfield of this discipline, and one that will need to rely on the hard sciences such as genetics and forensics.

Perhaps one encouraging conclusion is that despite what we have seen on the archaeology of past inequality, societies have been able to evolve and change their social stratifications. One example is Iceland the country has become one of the most egalitarian societies in the world. In 2018, Iceland passed a law that all companies employing more than 25 people will have four years to ensure gender-equal payment because, according to the head of the Equality Unit at Iceland's Welfare Ministry, "equality won't come about by itself, from the bottom up alone".

* This is an edited version of an article thatoriginally appearedinThe MIT Press Reader, and is republished with permission.

--

Carles Lalueza-Foxis Research Professor and Director of the Paleogenomics Lab at the Institute of Evolutionary Biology (CSIC-Universitat Pompeu Fabra) in Barcelona. He participated in the Neanderthal Genome Project and led the first retrieval of the genome of an 8,000-year-old European hunter-gatherer. He is the author of Inequality: A Genetic History, from which this article is adapted (this is an edited version of the original MIT Reader piece).

--

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Originally posted here:
Why some ancient societies were more unequal than others - BBC

Recommendation and review posted by Bethany Smith

Sample and design

We used data from the Longitudinal Aging Study Amsterdam (LASA). LASA is an ongoing, prospective cohort study, based on a representative sample of the older population in the Netherlands. LASA focuses on the determinants, trajectories and consequences of changes in physical, cognitive, emotional, and social functioning in older adults aged 55years or older. Measurements are conducted approximately every three years and include a main face-to-face computer assisted interview, a face-to-face computer assisted medical interview in which clinical measurements are performed and additional questions are asked, and a self-administered questionnaire. The study received approval by the medical ethics committee of the VU University medical center. Signed informed consent was obtained from all study participants. Sampling, response and procedures are described in detail elsewhere [28].

For the current study, we adopted a lagged-effect design, because we expected that with ageing, older workers would increasingly be affected by their gender role (our main determinant) and working conditions (our moderator/mediator), and that this would result in higher depressive symptoms scores in the course of time. Thus, we assumed a temporal precedence of gender roles and working conditions, as opposed to an immediate effect on depressive symptoms. Accordingly, data from 20122013 (T1) and 20152016 (T2) were used. At T1, 1023 respondents participated in the LASA study. We excluded those who did not have a paid job at T1 (n=395), those who did not participate at T2 (n=93), and those who did not have a paid job at T2 (n=222). We ended up with a sample of 313 older workers.

Our outcome measure was depressive symptoms, measured using the Center for Epidemiologic Studies Depression Scale (CES-D) [29]. The CES-D is a 20-item self-report scale ranging from 0 to 60, with higher scores reflecting more depressive symptoms. The outcome was measured at T2 (2015/2016).

All independent variables were measured at T1 (2012/2013).

We included biological sex, derived from the population registers, as an independent variable.

We constructed a gender index, based on the work of Smith and Koehoorn [9] on gender roles in the labour market. Smith and Koehoorn included four gender items in their index: responsibility for caring for children, occupation segregation, number of working hours, and level of education. Because in our sample of older workers responsibility for caring for children was not applicable, we chose to include a measure of informal caregiving. Providing informal care is much more common among women compared to men and is seen as a more feminine role [30, 31]. As suggested by Smith and Koehoorn, we also included a measure of household responsibilities. Furthermore, Smith and Koehoorn suggested to include a measure for primary earner status. Unfortunately this information was not available in our data. We therefore chose to include income in our index. While Smith and Koehoorn use relative measures (relative to the partner) for educational level and number of working hours, we use absolute measures for these items, because we consider absolute measures to reflect broader societal gender roles rather than gender roles within the household.

The gender index consisted of the sum score of six items: number of working hours, income, occupation segregation, level of education, informal caregiving, and time spent on household chores. For each gender item, a higher score represents more femininity and a lower score represents more masculinity.

Respondents were asked about their number of working hours per week. Responses were categorised into quartiles and recoded so that a higher score (i.e. a lower number of working hours) represents more femininity.

To assess the income of the household, respondents were asked what their monthly household income was, choosing from 24 categories, with the lowest category being 454-567 and the highest category 5446 or more. To ensure comparability of income between persons with and without a partner in the household, income was multiplied by 0.7 for respondents with a partner in the household. The factor 0.7 is the inverse of the squareroot of 2, i.e., the number of household members. This correction makes the incomes of all respondents equivalent to one-person household incomes [32]. Income was categorised into quartiles and recoded so that a higher score (i.e. a lower income) represents more femininity.

Occupation segregation was measured by the percentage of female workers in the sector. Using data from Statistics Netherlands, we assigned each sector to one of four categories in accordance with Smith and Koehoorn [9]: (0)25% female workers, (1) 2650% female workers, (2) 5175% female workers, and (3)76% female workers.

Respondents were asked about their highest completed level of education. We used the International Standard Classification of Education 2011 [33] to categorise educational level into three groups: (0) low (up to lower secondary education, ISCED 02), (1) intermediate (upper secondary education or post-secondary non-tertiary education, ISCED 34), and (2) high (short cycle tertiary and higher, ISCED 56). Again, scores were recoded so that a higher score (i.e. lower educational level) reflects more femininity.

Respondents were asked if they recently provided help with household chores to somebody outside the own household, and whether the respondent provided help with personal care to somebody inside or outside the own household. If so, questions were asked about the intensity (hours) of care. Informal caregiving was categorised into (0) not giving informal care, (1) giving<8h of informal care per week, and (2) giving8h of informal care per week.

Respondents were also asked about the time spent on light and heavy household chores. Time in minutes per day, averaged across the past 14days, was categorised into quartiles.

The gender index ranged from 022 and was dichotomised at the median into masculine (scores 07) and feminine (scores 822) to enable comparison of its association with depressive symptoms with the association of biological sex with depressive symptoms.

We used a written questionnaire to obtain data on working conditions [34]. Respondents could answer (1) never, (2) sometimes, (3) often, or (4) always to all questions on working conditions.

To measure physical demands five items were used: use of force, using tools that cause vibration or shaking, working in an uncomfortable position , standing for a long time, and kneeling down or squatting. Psychological demands consisted of two items: working very fast, and having to do a lot of work. For cognitive demands, six items were used: think of solutions, learn new things, requires creativity, requires thinking intensively, requires focus, and requires attention. Autonomy was measured with three items: control over how to do the job, control over sequence of tasks, and control over when to take time off. For variation in tasks one item was used: having variation in tasks. And for social support four items were included: help and support of colleagues, colleagues willing to listen to work related problems, help and support of supervisor, and supervisor willing to listen to work related problems.

Sum scores were made for each type of working conditions and scores were dichotomised using the median due to non-linearity.

Age was derived from the population registers.

Multiple imputation (MICE) was used to deal with missing values, which were assumed to be missing at random. All independent, control and the outcome variables were included in the imputation process and the number of imputations was set to 30, based on the percentage of missing values (28%) [35]. To assess to what extent the separate gender items as well as the gender index are associated with sex, we conducted logistic regression analyses [36]. We used Structural Equation Modeling (SEM) to estimate the associations visualised in Fig. 1. All analyses were adjusted for age. Separate models were examined for sex and gender. We used tobit regression analyses to estimate the associations of sex/gender and the working conditions with depressive symptoms, because the depressive symptoms scale is skewed to the right due to the detection limit at the lower end of the scale. Tobit models account for this left-censoring by assuming a normal distribution that is cut off (censored) at zero.

Visual representation of the moderation and mediation models

To test whether gender/sex is a moderator in the association between working conditions and depressive symptoms, we built models with an interaction between sex/gender and the working conditions (Fig.1A). In case of a statistically significant interaction, the association between the working conditions and depressive symptoms varies across sexes/genders.

To investigate whether working conditions explain the association between sex/gender and depressive symptoms, we built single mediator analyses (Fig.1B). To estimate the c paths (total effect of sex/gender on depressive symptoms) and the b paths (effect of the mediators on depressive symptoms, while controlling for sex/gender), we used tobit regression analyses, and for the a paths (the effect of sex/gender on the mediators), we conducted logistic regression analyses. We used causal mediation analyses to estimate the indirect effects [37]. We used bootstrapping techniques (500 repetitions) to calculate the 95% confidence intervals around the indirect effects. All analyses were carried out in Stata version 14.

See more here:
Sex and gender differences in depressive symptoms in older workers: the role of working conditions - BMC Public Health - BMC Public Health

Recommendation and review posted by Bethany Smith

The idea is if we dont look out the white race will bewill be utterly submerged. Its all scientific stuff; its been proved.

These are not the words of the teenager who walked into a supermarket in Buffalo, New York, on Saturday to hunt down Black Americans, although they might as well be. These are the words of Tom Buchanan, a rich, repugnant character in the 1925 novel The Great Gatsby.

Shortly before the massacre in Buffalo, authorities say, the shooter published a 180-page document that is an unpleasant mixture of the disconcertingly new and the horribly familiar. Underneath the superficial novelty of the suspects alleged actions (livestreaming the atrocity on Twitch, publishing the manifesto on Google Docs) and his vocabulary (his complaint about buying a cucked assault rifle that he had to modify, for example) is a sprawling, discredited ideology that was once entertained by respectable people and has now crept back toward the mainstream.

Graeme Wood: Why Tucker Carlson should want the Buffalo manifesto made public

The manifesto is steeped in early-20th-century scientific racismwhich motivated Gatsbys Buchananand the anti-Semitism that so often accompanied it. The document contains pages of memes about Jewish control of the world, plus scientific-looking scattergraphs of IQs broken down by racial group. Call this the intersectionality of hate: Just as academics have pointed out that marginalized identities (race, class, sex, disability) can overlap and reinforce one another, so too can old hatreds. Far-right movements are flexible about identifying the other from which their adherents are supposedly under threat. Many fascists see liberated women as a symbol of social decadence and decline. The KKK also targeted Jews. That an anti-Black racist like the Buffalo shooter would also be in thrall to anti-Semitic tropes might seem surprising, but intersectional hate is a totalizing ideology. Every new talking point is woven into the same tapestry, in which white men are at the center, protecting their women, and everyone else is at the margins.

The Buffalo shooter is open about the source of his radicalization. It was the internet, and specifically an anonymous discussion board on 4chan. There I learned through infographics, shitposts, and memes that the White race is dying out, he writes. He distributes the blame among Black Americanswhom he depicts as violent and lazyand the Jews and the elite who control them.

Although he doesnt mention them by name, the shooters grievance also lies with white women, through his invocation of falling birth rates and the Great Replacement, a conspiracy theory that accuses left-wing politicians of encouraging immigration to undermine majority white, Christian societies and create new, obedient voter bases. In his mythology, Black Americans are among the replacersa dehumanizing term repeatedly invoked in the documentwhile the masterminds of the replacement are Jews. This is one example of how hatreds amplify one another: If Black Americans are so inferior, how can they be a threat to the glorious white race? Ah, because they are being directed by shadowy puppet masters. And which group has been cast in this role throughout history? The Jews.

Yair Rosenberg: Why so many people still dont understand anti-Semitism

Although the American strain of white supremacy is distinctive, recent terrorists have been influenced by many overlapping ideas. The man who massacred 51 people at a New Zealand mosque in 2019 subscribed to the European version of Great Replacement theory, in which the demographic attack comes from Muslims, and Jews do not prominently feature. The gunman who killed 23 people at a Walmart in El Paso, Texas, the same year released a manifesto warning of a Hispanic invasion. The man who set fire to a mosque and shot four people in a synagogue in Poway, California, insisted in his own screed that Jews deserved to die for their role in feminism which has enslaved women in sin.

The ideology might be flexible, but it always returns the same answer: The West is in decline; the white race is under threat, and it must be protected by violence. In place of the messy truth that migration is a continuous churn driven by war, famine, and individuals desire for a better life, the Great Replacement suggests a coherent plan controlled by knowable forces. Such theories thrive in hard times, because they offer themselves as an antidote to chaos.

In the late 19th and early 20th century, Francis Galton and other then-respected scientists talked earnestly about classifying humans into superior and inferior races. Galtons heirs used the new technology of the IQ test, originally developed to identify children struggling at school, to collect proof of the alleged superiority of Europeans. Their work depended on definitions of whiteness, and rigid racial categories, that have since been debunked. (At various times in American history, Polish, Irish, and Italian immigrants would not have been considered white in the same way as those of Nordic stock.) Todays geneticists know better than to build their work on such shifting sands.

Nevertheless, the blithe assertions of early eugenicists and scientific racists are now being recast, a century later, in the clunky visual style of the modern internet, with its homemade cut-and-paste jobs of text overlaid on graphics. The anti-Semitic tropes in the Buffalo shooters manifesto could come straight from The Protocols of the Elders of Zion, a fabricated text about a minority with disproportionate powers to control the world, or Henry Fords Dearborn Independent. But these ideas are presented in picture form. Page after page identifies people who hold important jobs as Jews; readers are left to form their own (predestined) conclusion. Also included are tables of supposedly Jewish facial features that could have come straight from a 19th-century phrenology handbook. Hes saying something that Ive never seen so clearly expressed before, Adam Rutherford, a British geneticist who writes about scientific racism, told me. He was radicalized by infographics.

Kathleen Belew: White power, white violence

The slapdash, collage style of the manifesto is the true novelty here; the author discusses his underwear, his lunch plans, and his Myers-Briggs profile alongside his murderous hatred of Black Americans, Jews, and other races. This format underscores how todays terrorists tend to radicalize themselves, alone, at home. They are technically lone wolves but are in constant dialogue with the internets bleakest corners. The blizzard of facts and figures on far-right websites flatters them into thinking they have followed a trail of clues and arrived at the truth themselves, unlike the blinkered herd. It is a narcissistic fantasy that casts the young radical as the hero of his own questa detective story in which he is an active participant. Many mass shooters have a sense of grievance in search of a mythology. The manifestos author claims that he found communism at age 12 but rejected it when he found something more useful to his psychological needs.

Rutherford, the author of the book How to Argue With a Racist, studies how academic research into intelligence and population genetics is laundered for use on white-supremacist websites. He cites the example of a mainstream paper on inheritance that featured a scatterplot on characteristics of people of Jewish descent, and ended up in racist internet posts. The simple addition of group labels such as quadroon Jewsa term repurposed from Jim Crowera Americatransformed a careful scientific study into a piece of racist propaganda. This is using science to prop up a preexisting ideology. Its exactly what happened in the 1900s with the [genetics] work of Gregor Mendelthe eugenicists seized on it, Rutherford said. Its the same as it ever was. New techniques, old story.

People drawn to intersectional omni-hatred can find multiple on-ramps online. One way into this mindset is through tasteless jokesmany users of sites such as 4chan see mocking the Holocaust as thrillingly transgressive. But ironic anti-Semitism expressed for shock value can shade into overt, unironic anti-Semitism expressed as a genuine belief. Another on-ramp is the debate, now simmering for more than a century, about the supposed connection between race and intelligence. Modern geneticists are reluctant to make sweeping statements about populations, but their nuanced disputes about the influence of environment versus heredity are presented instead by the far right as the left-wing suppression of obvious but unspeakable facts. (The resurgence of scientific racism as a political force poses a challenge to genetics researchers, many of whom would prefer to dodge these controversial questions altogether but risk leaving the field clear for cranks.)

Adam Serwer: Demography is not destiny

Anti-feminism is also a route to the far right. Nearly all mass shooters are men, and the tone of many far-right sites assumes that all their readers are male. White women mainly exist in this ideology to be protected from rape by invaders or from their own desire to have children with nonwhite men. Feminism is a threat because it frees women from mens economic control and might encourage them to pursue careers at the expense of motherhood. The Buffalo shooter invoked a white-supremacist slogan: We must secure the existence of our people and a future for white children. The we are white men, framed as soldiers and martyrs, posing as the heroic defenders of the weak. A power fantasy is baked into this ideology, but so is feara clammy horror of becoming redundant and obsolete.

In the 1920s and 30s, a prominent man could voice his discriminatory thoughts about inferior races and the international Jew out loud, in public; Gatsbys fictional Buchanan had real-life counterparts in Ford and Father Coughlin. In the century since, pseudoscientific racism has been driven to the margins of society and appears instead in watered-down forms, in allusions, winks, and dog whistles. (Especially after the Buffalo shooting, the Fox News host Tucker Carlson has been widely criticized for promoting the Great Replacement theory. But as my colleague Graeme Wood notes, Carlson could not keep his job if he presented it in the grotesque terms expressed in the shooters manifesto.) Yet the banishment of overt scientific racism from the public square has given it a new glamour online, where it marinates alongside other forms of hatred and draws adherents who convince themselves that urgent truths are being suppressed. That mindset allows young men to brick themselves inside a mental castle of half-truths and old lies, fed by their own sense that they deserved better, and they could be remembered as a hero, if only they picked up a gun.

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The Intersectionality of Hate - The Atlantic

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Complete mitochondrial genome assembly

The mitogenomes of St, Sc, and StSc were assembled into five to two subgenomes through de novo assembly using 5.3 to 6.6Gb PE reads. Each assembly was validated by conducting PCR analysis and sequencing (Tables S1 and S2, Fig. S1). The St mitogenome size was 756,058bp, and it was composed of five circular subgenomes of lengths 49,230 to 297,014bp. The total number of non-redundant genes was 78, consisting of 37 PCGs, 19 ORFs, 3 rRNAs, and 19 tRNAs (Table 1, Fig. S2A). The Sc mitogenome was 552,103bp in size with two subgenomes (338,427 and 213,676bp). The total number of non-redundant genes was 77, consisting of 37 PCGs, 20 ORFs, 3 rRNAs, and 17 tRNAs (Table 1, Fig. S2B). The StSc mitogenomes were 447,645bp in size with a major circular DNA of 398,439bp and a minor subgenome of 49,206bp. The total number of non-redundant genes was 77, consisting of 37 PCGs, 20 ORFs, 3 rRNAs, and 17 tRNAs (Table 1, Fig. S2C).

A total of 71 genes were shared among the three mitogenomes. Some genes were unique in each mitogenome: four ORFs (orf131, orf 190, orf 240, and orf 279), and three tRNAs (trnI-GAU, trnL-CAA, and trnV-GAC) were unique in the St mitogenome; five ORFs (orf109d, orf111, orf140, orf185, orf240) and one tRNA (trnfM-CAT) were unique in the Sc genome; and five ORFs (orf111, orf127, orf131, orf140, orf185) and one tRNA (trnV-GAC) were unique in the StSc mitogenome (Table 2).

Mitochondrial plastid DNA (MTPT) has been reported in various plants, such as Amborella trichopoda, Zea mays (maize), and Cynanchum wilfordii34,35,36. The degree of MTPT was examined by sequence comparison with the S. tuberosum plastome sequence (GenBank accession No. no. KM489056)37. Consequently, the St, Sc, and StSc mitogenomes were approximately 1.08.0%, 2.98.0%, and 3.14.0% considered as MTPT, respectively. Overall, approximately 1.08.0% were identified as MTPT (Table 1, Fig. S2).

Further, nuclear mitochondrial DNA (NUMT) has also been reported in various plants, such as Arabidopsis thaliana and Cucumis sativus (cucumber)38,39. NUMT was identified by sequence comparison with the S. tuberosum nuclear genome sequence (SolTub_3.0, https://www.ncbi.nlm.nih.gov/assembly/GCF_000226075.1/). Consequently, the St, Sc, and StSc mitogenomes were approximately 17.257.7%, 16.117.4%, and 10.116.3%, respectively, which were considered to be derived from or transferred to nuclear genomes accordingly. Overall, approximately 10.757.7% was identified as NUMTs. A total of 57.7% was identified in St subgenome 4, which has a very small genome size (Table 1, Fig. S2).

Homologous recombination (HR) can be mediated by repeat sequences in St, Sc, and StSc mitogenomes. The St, Sc, and StSc mitogenomes accounted for approximately 2.219.4%, 4.821.3%, and 5.725.9% of repeat sequences in which the repeat ratio was also positively correlated with the subgenome size (Table 1, Figs.1 and S2). The five St subgenomes exhibited diverse numbers of dispersed repeats: 300 (mitogenome coverage: 19.4%), 211 (15.2%), 41 (5.5%), 18 (2.2%), and 39 (4.9%) in each subgenome (Tables 1 and S5, Figs.1A and S2A). The two Sc subgenomes included 460 (25.9%) and 198 dispersed repeats (15.2%) (Tables 1 and S5, Figs.1B and S2B). Further, the two StSc subgenomes contained 480 (21.3%) and 39 (4.8%) dispersed repeats (Tables 1 and S5, Fig.1C and S2C). In contrast, tandem repeats were selected with adjacent sequences of at least two copies and up to 50bp. The St, Sc, and StSc mitogenomes had only 17, 20, and 16 tandem repeats, respectively (Table S6).

Chord diagram of three Solanum mitogenomes. (AC) represent the homologous regions of the subgenomes. R1 to R3 represent the large repeats that might cause homologous recombination among the corresponding subgenomes. St: S. tuberosum accession no. PT56, Sc: S. commersonii accession no. Lz3.2, StSc: somatic hybrid accession no. HA06-9.

Two large repeats (more than 1kb) were identified in the St subgenome 1. R1 was 11,916bp, and R2 was 7500bp. In contrast, St subgenome 2 had only R1, and subgenome 3 had only 1589bp of R3. Similarly, the R1 sequence co-existed in St subgenomes 1 and 2. The R2 repeat is shared between subgenomes 1 and 4 (Table S5, Figs.1 and S2), which might contribute to the HR between different subgenomes. The Sc mitogenomes had two multipartite structures, in which three large repeats of more than 1kb were identified (R1: 16,857bp, R2: 10,094bp, and R3: 1024bp), which might contribute to recombination events between subgenomes (Table S5, Figs.1 and S2). The StSc mitogenomes contain four large repeats (more than 1kb) (R1, 11,916bp; R2, 11,846bp; R3, 1643bp; and R4, 1024bp) that might contribute to subgenome reshuffling (Table S5, Figs.1 and S2).

We compared plastomes, mitogenomes, and nrDNAs among St, Sc, and StSc genomes. The StSc plastome was identical to Sc plastome37. Meanwhile, the StSc mitogenome shows a complicated structure with unique genes derived from both species (Table S3, Fig.2). Among 71 common genes, 21 PCGs (nad3, nad4, nad4L, nad5, nad6, sdh3, cox2, cox3, atp1, atp4, atp8, atp9, ccmB, rps3, rps4, rps12, rps13, rpl5, rpl10, rpl16, and mttB) were found identical across the three mitogenomes (denoted as green boxes on Fig.2) and their origin in the StSc genome could not be determined; 12 PCGs (nad1, nad2, nad7, nad9, sdh4, cob, cox1, ccmC, ccmFc, rps10, rpl2, and matR) were found identical with Sc (represented as sky-blue boxes in Fig.2) and 2 PCGs (atp6 and ccmFN) were identical with St (pink boxes in Fig.2). Therefore, it is likely that the majority of the somatic hybrid mitogenomes originated from Sc (Fig.2).

The origin of mitogenome recombination block in somatic hybrid (StSc) (A) Subgenome 1 of somatic hybrid mitogenome (B) Subgenome 2 of somatic hybrid mitogenome. The pink and sky-blue triangles on the black middle line indicate genes derived from S. tuberosum and S. commersonii, respectively. The green diamond boxes indicate genes of unknown origin.

GISH data using Sc genome probes revealed strong signals in 24 chromosomes but weak signals in the other 24 chromosomes in the StSc somatic hybrid (Fig.3A). We also assembled and compared 45S nrDNA cistron sequence of three species. For example, multiple aligned position at 191bp represents T genotype in St and C genotype in Sc. However, in StSc, it was identified that 75.6% of T and 24.4% of C were present. In conclusion, the overall 45S nrDNA sequences of StSc revealed both genotypes with average about 70 and 30 ratio for Sc and St, respectively (Fig.3B).

Detection of nuclear genome fusion in somatic hybrid. (A) GISH analysis of somatic hybrid (HA06-1 clone) using S. tuberosum specific-probes. The red signal of 24 arrows indicates the S. commersonii nuclear subgenomic distribution. (B) Schematic diagram of 45S ribosomal DNA cistron of Solanum species. StSc summary represents the percentage of St or Sc genotypes in the 45SnrDNA sequence.

In summary, St, a dihaploid of tetraploid cultivated potato, has five mitogenomes. Sc, a diploid wild potato, has two mitogenomes. Somatic hybrids developed via protoplast fusion of these two diploids contain the Sc-unique plastome37 but recombined mitogenomes and nuclear genomes derived from both St and Sc genomes (Fig.4).

Schematic diagram of mitogenome in parental species and their somatic hybrids. (A) S. tuberosum (St), (B) S. commersonii (Sc), and (C) somatic hybrid (StSc). S. tuberosum and S. commersonii have five and two subgenomes, respectively, which are fused into two subgenomes in the somatic hybrid generated by protoplast fusion. The origin of chloroplast genome in somatic hybrid has been determined based on sequence comparison among chloroplast genome sequences of parental species and that of the somatic hybrid.

A total of 35 PCGs were common across Solanaceae. The nonsynonymous substitution (Ka), synonymous substitution (Ks), and their ratios were calculated. The Ka values ranged from 0 to 0.119 with a 0.003 of median value. The nad4 and nad4L genes had the lowest Ka values, while atp6 had the highest Ka value. The Ks values ranged from 0.02 to 0.228 with a 0.01 of median value. Moreover, mttB and atp6 had the lowest and highest Ks values, respectively. Lastly, the Ka/Ks values ranged from 0 to 3.528 with a median value of 0.286 (Table S8, Fig.5A). A Ka/Ks value of more than 2 was observed due to the extremely low Ks value.

Mitochondrial gene diversity in Solanaceae family. (A) non-synonymous substitution (Ka) and synonymous substitution (Ks) values among the 12 Solanaceae species. Ka and Ks values were calculated with 35 protein-coding genes by CodeML program. (B) Variations of atp6 are shown by the phylogenetic tree and multiple comparisons of amino acid sequences. The conserved domain has been determined through NCBI BLASTP search.

Although the Ka and Ks values were generally low, ccmFc and mttB exhibited high Ka/Ks values of more than 1, indicating that these genes were positively selected during evolution (Fig.5A). Considering that atp6 showed a high mutation rate above 0.1. Ka and Ks values relative to the other genes, the amino-acid sequences corresponding to atp6 were compared among Solanaceae species, which revealed that amino acid sequences were variable at the N-terminus but conserved at the C-terminus (Fig.5B).

Phylogenetic trees were constructed using various programs, including RAxML, MEGA7, PhyML, and BEAST to examine the topology of the species. Trees treated with RAxML, PhyML, and BEAST displayed the same topology, while those treated with MEGA7 exhibited slightly different topologies (Fig. S3). In trees generated using RAxML representing an optimized topology (Figs.6 and S3), Solanaceae species were divided into two subfamilies, Solanoideae and Nicotianoideae, and the somatic hybrid exhibited a moderate branch between St and Sc. During the evolution of Solanaceae mitogenome, first, rps1 and rps19 were present in Solanaceae, however, these were omitted completely in Oleaceae. Next, rps7 was confirmed to be completely deleted in Solanaceae compared to Oleaceae. Lastly, ycf14 in all Nicotianoideae species was pseudogenized in the divergence period between Solanoideae and Nicotianoideae (Fig.6).

Phylogenetic relationship of 13 Solanaceae species using 35 protein-coding gene sequences commonly conserved in mitogenomes. The maximum likelihood tree was constructed using RAxML program with GTR++I model (based on jModelTest2) and a bootstrapping value of 1000. The bootstrap value (>=0.5) is shown on the node. Deleted genes and pseudogenes specifically within each group in the tree have been also shown by red and black boxes, respectively. Olea europaea in the Oleaceae family has been used as an out-group.

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Mitochondrial genome recombination in somatic hybrids of Solanum commersonii and S. tuberosum | Scientific Reports - Nature.com

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AUTHOR:Scott T. Vergano, MDDepartment of Pediatrics, Childrens Hospital of The Kings Daughters, Norfolk, VA

CITATION:Vergano ST. Top papers you may have missed in April 2022. Consultant360. Published online May 18, 2022.

A policy statement this month is so important that I have chosen to focus most of my commentary on it. In addition, I note several other relevant publications that appeared in the month of April.

Please feel free to share with your colleagues, discuss in your offices, and write toeditors@consultant360.comwith your thoughts and opinions. As always, I am interested in hearing your thoughts and responses.

Here are my selections:

Health Supervision for Children and Adolescents With Down Syndrome1 The most important publication this month is this update to the 2011 Academy of Pediatrics (AAP) guidance on Health Supervision for Children With Down Syndrome. I read and reference this policy statement every time I do a check-up for a patient with Trisomy 21 and often give it out to families as well. (In my old paper charts, it was stapled to the inside of the front of the chart.) Here are the most significant changes that I notice compared with the previous statement:

The AAP Council on Genetics has issued equally valuable guidelines on health supervision for numerous other genetic conditions, in addition to Trisomy 21. The disorders covered by current policy statements include achondroplasia, Williams syndrome, neurofibromatosis type 1, and Marfan syndrome.

Childhood Cardiovascular Risk Factors and Adult Cardiovascular Events2

The authors of this multinational prospective study follow 38,589 participants over a mean of 35 years and record 319 fatal and 779 fatal or non-fatal cardiovascular events in adulthood. They identify 5 childhood cardiovascular risk factors: body mass index, systolic blood pressure, total cholesterol level, triglyceride level, and youth smoking, and examine whether these risk factors are predictive of fatal and non-fatal cardiovascular events in adults. After calculating a z-score for individual and combined risk factors, they conclude that risk factors identified in childhood are positively associated with mid-life cardiovascular events. The strongest association is noted with youth smoking and the weakest with total cholesterol level.

Crossing LinesA Change in the Leading Cause of Death among U.S. Children3This editorial from theNew England Journal of Medicine (NEJM) notes that the leading cause of death in children in the United States from ages 1 to 24 years has changed since 2017; it is now firearm-related injuries and no longer motor vehicle collisions (MVCs). The change is related to both a decrease in MVCs and an increase in firearm-related deaths, particularly homicides and suicides in older patients within the cohort. Two comments posted on the NEJM website criticize choosing an unconventional definition of children to make the statistics justify the conclusion.

Annual STI Testing Among Sexually Active Adolescents4

The addition of a question about sexually transmitted infection (STI) screening on the biennial national Youth Risk Behavior Survey administered in schools enabled the authors of this publication inPediatricsto assess the frequency of STI screening among adolescents who acknowledge having sex within the last 3 months. They find that 26.1% of sexually active female students and 13.7% of male students report having been tested for STIs in the previous year. They conclude that adherence with guidelines for STI screening among adolescents appears suboptimal. Current national guidelines recommend annual screening for gonorrhea and chlamydia in sexually active adolescent females and males who have sex with males, but not in all adolescent males.

References:

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Top Papers You May Have Missed in April 2022 - Consultant360

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According to a February 2022 Gallup poll that should have been far bigger news than it was, a whopping 20 percentone in five, that isof Generation Z American adults (born 1997-2003) now identify as LGBTQ. That trend shows a sharp upward slope with every successive generation. In fact, LGBTQ identification has roughly doubled with each new generation: The respective numbers for millennials (born 1981-1996), Generation X (born 1965-1980), baby boomers (born 1946-1964), and those born before 1946 are 10.5 percent, 4.2 percent, 2.6 percent, and 0.8 percent. Looking at Americans as a whole, 7.1 percent of us now identify as LGBTQ, double the 3.5 percent who so identified in 2012, not so very long ago.

The identitarian advocates take on this development will undoubtedly be that it reflects nothing more than growing freedom, the growing openness within a previously repressive society to once-suppressed modes of sexual expression. It was always the case, that narrative would go, that some 20 percent of us, or perhaps even more, had non-traditional sexual preferences, but society used to force all but the boldest and most determined into a single narrow lane. Sexual preference, after all, is biologically determined and not a choice, as we are repeatedly told by advocates.

That narrative, I would suggest, is patently absurd. It is itself the result of a pernicious mode of suppression, the suppression of speech and science that would point in a different and more obvious direction. The reality, as history and science convincingly demonstrate, is that human sexuality is highly malleable and amenable to social cues, norms, and proscriptions.

Take a case in which the range of acceptable sexual practices has narrowed rather than broadening over time, namely, the age of consent. In the ancient and medieval world, marriage largely tracked biological maturity. Girls could be married, often to significantly older men, at tender ages such as 14 or 15, if not younger. The acceptable marriage age was 12 in ancient Rome, for instance, a practice echoed by the guidance of the Catholic Church in medieval times. A piece of progressive legislation in England in 1875 raised the age of consent to sexual relations for girls from 10 to 13. Our present-day norms shifting such matters to the late teen years are, historically speaking, a blip on the screen.

Does this mean, following the logic of LGBTQ advocates, that it is normal and natural for grown men to be attracted to and have sexual relations with barely post-pubescent girls and that only the force of legal repression and social taboos is keeping such desires from manifesting themselves en masse? Not at all, I would argue. Rather, most of us are amenable to a range of sexual practices. We respond to environmental and social conditioning, particularly during certain critical periods of our maturation. We react to what we are told and to what we see all around us in America today, whether in images and videos or among our elders and our peers. And the result is that most of us, in contrast to our ancestors, are genuinely not attracted to young teens. We find the prospect repugnant for much the same reason that those raised in cultures in which insects, dogs, or fellow humans are not eaten are generally repulsed by even the notion of such consumption, while these may be perfectly natural and even relished foodstuffs for those who came of age in other societies.

Take a few other examples closer to the topic at hand. We know that it was not uncommon for ancient Greek men to engage in the practice of pederasty, i.e., to be both married to their wives and, at the same time, to take on boys in their mid-teen years to enjoy carnal relations while simultaneously providing mentorship to their younger brethren. In Melanesia, among the Etoro people, boys drinking of the semen of their elders is a coming-of-age ritual, and homosexuality is the norm, interrupted by brief periods of heterosexuality, which is considered sinful;among the Marind-anim, husbands routinely engage in sexual relations with their sisters adolescent sons, while wives engage in ritualized sex in groups. What the existence of these various practices, and more like them throughout the world and throughout history, should be sufficient to show is that human sexual preferences are relatively fluid and largely determined by governing norms rather than innate biology.

We might also consider in this connection a less controversial example demonstrating how our own sexual preferences have drifted over time in the West. We can observe this by looking at changing images of female beauty across many centuries, or we can simply think back to more recent American history: While the present-day ideal is more curvy and athletic, the waif supermodel look constituted our ideal just a few decades ago. Surely we do not believe that the heterosexual male brain, over the course of these years, underwent genetic changes sufficiently significant to alter our fundamental desires. Rather, we responded to social currents that substantially shifted those core desires.

Turning from history and anthropology to science, the search for the advocates holy grail, the gay gene, has consistently come up empty. In fact, a massive 2019 study that correlated the genomes and sexual practices of some half a million people in the U.S. and Europe found not only that no single gene predicted homosexuality but that even the five most seemingly salient genetic markers accounted for less than 1 percent of the differences among reported sexual preferences. When researchers then looked at overall genetic similarity among those who reported having same-sex experiences, genetics accounted for only between eight and 25 percent of the outcome. Clearly, in other words, some mysterious combination of the sum-total of social and environmental factors is doing the brunt of the work.

We have strongly suggestive evidence, moreover, that social cues can play causal roles in swaying impressionable teens to adopt new sexual identities. A much-discussed 2018 study from Brown University professor, physician, and researcher Lisa Littman looked at 256 teens who had suddenly come out as transgender after a childhood with no sign of gender dysphoria. Among 86 percent of those teens, the majority of whom had had at least one other mental disorder, the coming out moment was preceded by increased use of social media and/or multiple friends having come out shortly before. Just as tellingly, a large number of studies have confirmed that between 60 percent and 90 percent of kids and teens who think they are transgender grow up, if their bodies have not been altered by surgery and hormones in the interim, to be adults who no longer want to transition (and, instead, usually turn out merely to have same-sex mate preferences).

The simple message such research conveys is something that those of us who have not lost touch with our childhood and our awkward teen years will find unsurprising, and indeed, even obvious: Most kids and teens are works in progress and undecided and confused about many key aspects of their lives. The realm of sexuality, mysterious and alien to the domain of childhood experience, both by nature and by design, falls for many into that undecided and confused category. There is no question that some kids are very clearly straight from the get-go, and others are just as clearly and decidedly gay. But there are likely many children and teens who fall somewhere between the poles, a likely reason why even among those in Generation Z who identify as LGBTQ, more than half place themselves in the uncommitted category of bisexual. Just as the rest of what will become our more-or-less abiding tastes in life are in flux and in the process of congealing, our likes and dislikes when it comes to all things sexualwhat we find desirable as far as body types, personality types, fantasies, fetishes and, yes, even heterosexual, homosexual, or other core sex and gender preferencesmay be in varying states of limbo during these tender years.

Complex interactions between our particular biologies, personalities, and environments are going to matter a great deal in determining ultimate outcomes. Imagine, for example, a naturally rebellious kid growing up in an environment in which coming out as trans is the cool, new, outr trend sweeping the nation, offering an opportunity to poke a thumb in the eye of bewildered parents and other elders. Or imagine a sensitive, weak-willed soul craving social approval and finding good friends around her coming out as lesbian or bi-curious. Now imagine these same kids coming of age in a society where deviations from the traditional heterosexual norm are rarities. Here, unless that rebellious kid is really rebellious, we might get a different outcome.

Much of the nuance inherent to this discussion gets routinely swept away when we pose the problem as a false, politicized dichotomy between biological determinism and individual free choice. The American Psychological Association, for instance, warns us sternly that psychologists do not consider sexual orientation to be a conscious choice that can be voluntarily changed. At least the first part of that proposition is likely true in most cases (and the second part is true for most as well, if what is envisioned is a voluntary change to be made on a dime), but it is a dodge rather than a revelation. There is probably no single moment when an individual chooses to become attracted to members of the same sex any more than there is a moment when we choose to become attracted to redheads. And yet in no way does that imply that we are born with a thing for redheads.

We, as individuals, may not make such choices, but we, as a society, certainly do. As the evidence drawn from other societies across the world and throughout history shows us, the examples we set, the images we project, the information and education we convey, the manner in which we organize our lives and our institutions, all of these will bear upon the prevalence of LGBTQ lifestyles in our midst. We cannot evade our responsibility. It is for us to choose the society in which we want to live.

* * *

In contemplating our options and asking ourselves whether an America in which 20 percent or more of a rising generation identifies as LGBTQ is the America we want, we might consider the following. In a phenomenon characterized by some as The Mystery of the Declining U.S. Birth Rate, our birth rate as of 2020 was 55.8 births per 1,000 women of childbearing age, a steep drop of about 15 percent from 2007, when that number was 69.3 per 1,000. Much of this alleged mystery is solved when we consider the revolution and exponential increase in LGBTQ acceptance and LGBTQ lifestyles that occurred over roughly the same period. Support for same-sex marriage, for example, stood at a meager 27 percent of Americans in 1996 and was still in the low 40 percent range around 2007, but skyrocketed to 70 percent by 2021. In one fell swoop, the U.S. Supreme Court struck down all state laws criminalizing homosexual conduct in the Lawrence v. Texas decision in 2003, and in 2004, Massachusetts became the first state to legalize same-sex marriage. By 2012, President Obama, in a reversal of his earlier professed views, was endorsing same-sex marriage, and just one year later, the Supreme Court was again getting in on the act, making it unconstitutional to deny federal benefits to same-sex spouses.

Empirical work that accounts for a cultural lag, viz., a period of delay between a cultural landmark and a resulting widespread social change, makes clear the correlation between the legalization of same-sex marriage and declining fertility rates. The dire consequences of those declining fertility rates include an older population and a smaller workforce, resulting in lower growth and economic productivity, even while there are fewer working-age people available to be taxed in order to support the social security system on which an aging population is dependent. If we continue along our present path, in short, we will find ourselves living in an America afflicted by the same population collapsethat has devastated much of Europe and made it reliant on culturally destabilizing mass immigration (from the more socially conservative, and thus more demographically healthy, third world) to sustain its fading economies.

But beyond even the level of these purely practical considerations, we should consider the cultural significance of a society deviating ever further from traditional family structure and traditional sexuality. The reason alternative lifestyles are proliferating among us, after all, is not merely on account of our greater tolerance for such choices. That explosive push for greater tolerance in recent decades was itself kindled by the long-simmering flame of 1960s counterculture increasingly institutionalized and ensconced in positions of power. Rebelling against the conformity of a post-World-War II nation lorded over by strait-laced military heroes and veterans, the baby boomer generations counterculture unleashed a ferocious assault on such conformity, championing rebels, drop-outs and deviants. Free expression and non-traditional lifestyles were core components of this go-your-own-way generations message.

What occurred as a predictable result is the undermining of all erstwhile sources of stability and meaning, whether organized religion, local community life or the institution of the family and the sexual practices associated with it. Just as organized religion gave way to a desperate hankering after alternative modes of spirituality through which individuals sought a more intimate, personal connection with the divine, traditional heterosexual relationsassociated with procreation, family life, and suddenly restrictive patriarchal normsbegan to give way to a desperate hankering after alternative modes of sexual expression through which individuals sought a more intimate, personal connection with themselves and one another. Anticipating these developments in his 1955 work, Eros and Civilization, the Frankfurt School alum and Father of the New Left Herbert Marcuse encapsulated this sense that sexual deviancy, with its defiance of paternalistic sexual norms, was a pursuit of some species of greater pleasure than that available through the thing that everyone did:

The perversions seem to give a promesse de bonheur [i.e., promise of happiness or gratification] greater than that of normal sexuality. What is the source of their promise? Freud emphasized the exclusive character of the deviations from normality, their rejection of the procreative sex act. The perversions thus express rebellion against the subjugation of sexuality under the order of procreation, and against the institutions which guarantee this order. Psychoanalytic theory sees in the practices that exclude or prevent procreation an opposition against continuing the chain of reproduction and thereby of paternal dominationan attempt to prevent the reappearance of the father. The perversions seem to reject the entire enslavement of the pleasure ego by the reality ego. Claiming instinctual freedom in a world of repression, they are often characterized by a strong rejection of that feeling of guilt which accompanies sexual repressionIn a repressive order, which enforces the equation between normal, socially useful, and good, the manifestations of pleasure for its own sake must appear as fleurs du mal [i.e., flowers of evil]. Against a society which employs sexuality as means for a useful end, the perversions uphold sexuality as an end in itselfThey establish libidinal relationships which society must ostracize because they threaten to reverse the process of civilization which turned the organism into an instrument of work.

Here is the catch: As the Berkeley sociologist Robert Nisbet argued in far greater detail in Community and Power (1962), the detachment of more and more individuals from traditional communal institutions and practices creates a vicious circle. Their more intrinsic rewards aside, organized religion and the traditional family confer the most meaning and personal satisfaction upon individuals when such institutions are widely esteemed and directly connected to external hallmarks of value, whether exclusive economic benefits or cherished social standing. When more and more of us jump ship while economic and social value and esteem are shifted elsewhere, what remains behind will no longer seem as appealing. The old forms will lose their haloes, the sense of an enchanted life in which they could once envelop us. But because the new modes of expression arising in place of the old are explicitly posed as antinomian, counter-hegemonic, and individualized, they, of necessity, cannot succeed in effectuating a complete transfer to themselves of that elusive sense of wholeness and enchantment associated with their predecessors. What they inevitably bring about, instead, is a version of the hedonic treadmill, as the next fleeting spiritual and sexual trend succeeds the last in ever-more rapid succession, with proponents of each successive iteration repeatedly finding themselves looking in the rearview mirror at speeding bandwagons overtaking the ones they had only recently mounted. And this, of course, is precisely what we have seen arise among us, as the icons of one sexual revolution, such as Martina Navratilova, become the demonized rearguard impeding the progress of the next wave. The unsurprising end result is an all around loss of collective and individual meaning and life satisfaction, as society degenerates from a crucible refining a diverse citizenry into a sturdy universal alloy to a spinning centrifuge unceremoniously hurling more and more of us outward toward irreconcilable opposite poles.

To be sure, the lost soul hankering after ever-better alternatives or desperately switching from one gender to another and back in search of that elusive sense of calm in the storm is a victim caught in our social maelstrom and need not be blamed, scolded, or stigmatized for our collective failings. The solution to this problem is communal, not individual. It is about what we teach and dont teach our children at school, what we show and dont show them on screens, what our laws prohibit and permit, what our institutions incentivize and disincentivize, what our psychological, psychiatric, and medical associations adopt and reject as their governing norms and ideologies. Making the lives of gay or transgender people more difficult than they may already be is a far less appealing option than making gay or transgender lifestyles less appealing in the first place. There are those, as I have said, who will be gay in any society. They have always existed. Let them be. It is the far larger number of toss-up cases with whom we are concerned. Instead of punishing adults after the fact, let us work to avoid tempting kids to make the errors in judgment that lead them into the wilderness.

And let us, most of all, endeavor with all our collective imagination and resolve to re-mythologize and re-enchant our traditions and traditional sexual experiences that the counterculture has done its utmost to uproot. We do this by changing laws and norms, yes, but we do it, first and foremost, by singing hymns, erecting images, and telling stories, both real and fictional, both sacred and secular. A few well-rendered tales of great doomed loveRomeo and Juliet, Anthony and Cleopatra, Troilus and Cressidawill save more souls than a thousand legislative enactments ever could. We must preach this gospel vigorously and persistently not only for the sake of our own congregation but for the sake, still more, of those who have strayed and who do not realize that what they were seeking was waiting for them right here at home all along.

Alexander Zubatovis a practicing attorney specializing in general commercial litigation. He is also a practicing writer specializing in general non-commercial poetry, fiction, essays, and polemics that have been featured in a widevariety of publications. He lives in the belly of the beast in New York, New York. He can be found on Twitter@Zoobahtov.

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CHENNAI: In 2004, flight attendant Kaveri Mandanna was battling frequent fevers, cold, and dipping haemoglobin. Life was an endless series of check-ups and blood transfusions. After consultations with a haematology specialist, tests and procedures ensued. Kaveri's condition was found to be leukaemia -- it meant that her bone marrow tissue was rapidly producing abnormal numbers of a certain type of blood cell, crowding out the others.

Although shaken, she didnt want to lose hope. "I had to be alive for my daughter -- that was the only thought pushing me to fight," says Kaveri who was in her 30s then.

A bone marrow transplant, also called a stem cell transplant, was recommended as a recourse. That gave Kaveri additional succour.

"Today, people suffering from rare diseases like certain types of cancer, sickle cell anaemia, immune conditions, and other conditions affecting the production of blood, have a shot at being cured through such stem cell transplants," says Dr G Buvaneswari, infertility specialist, Rela and GBR Hospitals.

Stem cells are special cells which can create copies of themselves. "These are the bodys raw cells -- they keep dividing and evolving into other cell types such as the bones, heart muscle, nerves, other organs and tissue," explains Dr Buvaneswari.

Its a matchThe tricky part of such transplants? Finding an immunologically compatible donor. As Kaveri had two siblings, who are natural genetic matches, they were HLA-typed.

Explaining this, Dr Buvaneswari says, "This procedure identifies protein markers on cells and tissues. The markers help determine whether or not a donor and a beneficiary match."

The more the markers, the fewer the risks of infection. To Kaveri's luck, her younger brother was found to be eligible to donate.

Uthappa, Kaveris brother and donor, was glad that he could potentially save his sister's life. However, he was apprehensive, too.

"Blood from one of my arms was collected every day, for five days, for a few hours. It was a smooth process, but, still, I was worried I'd experience side effects after giving away my stem cells," says Uthappa. But there was no cause for concern, he found, as donors are given injections to replicate extra bone marrow stem cells.

On D-day of the transplant process, Uthappa's stem cells were introduced into Kaveri's body via a catheter. Meanwhile, Kaveri had undergone chemotherapy which emptied her bone marrow of all its blood cells, including the healthy ones. This is done to make space for the donor's stem cells, says Dr Buvaneswari.

With time, the transplanted stem cells travelled to Kaveris bone marrow, where it started producing healthy red blood cells, white blood cells, and platelets of its own.

Kaveri still needed to do check-ups at regular intervals. "At first, I had to meet my specialists every week. Then, the frequency reduced to quarterly sessions, and later, once a year," Kaveri recounts. Subsequent signs of her cell count returning to the normal number indicated disease remission.

Almost six years later, from the day of the transplant in 2004, Kaveri's cancer was cured. "The transplant's success and the blessing of being declared cancer-free gave me the confidence to resume my globe-trotting life," she exclaims.

Banking for the futureWhile Kaveri was lucky enough to find a biologically-related donor, the odds in general are not quite high. Contacting a registry of voluntary unrelated donors is the only option then.Healthy individuals between the ages of 18 to 60 can register to donate their blood stem cells, says Sumati Misra, head, counselling and transplant centre management at DATRI blood stem cell registry. Having a wide pool of registered donors increases the odds of finding HLA matches for those needing transplants, she says.

"At DATRI, we have 1,800 patients registered with us who havent found a match yet from our registry of almost four lakh registered donors," shares Sumati.

Another factor in HLA typing is ethnicity, thus, it's hard to find a European registry match for an Indian. A large Indian donor registry solves that problem, she suggests.

Did you know that umbilical cord blood is a rich source of stem cells?

"The cord and the placenta, generally discarded as medical waste. They can be saved, and the stem cells from the tissue and the blood extracted, and stored for future transplant use," says Dr Buvaneswari.

As the blood is tested for infections, the likelihood of a person's body rejecting stem cells from cord blood is lesser than from bone marrow.

Some parents pay for their children's cord blood cells to be cryo-preserved in private banks for an extended period of time. They can be used in the rare event of a child developing a condition, in the future, that can be treated with stem cell therapy. The child's siblings stem cells, too, if they are HLA matches, can prove helpful.

"If the child is found to be an HLA match with another child, alternatively, parents can take a call on donating the banked cord blood. As cord blood banking is an expensive undertaking, donating them may be ideal," suggests Dr Buvaneswari.

Research on stem cells is underway to see if they can treat various conditions that affect different systems and parts of the body. Stem cell therapy could be a prospective game-changer in not just regenerating tissues but also organs, says Dr Buvaneswari, who is currently researching the use of stem cells in infertility treatment.

Sharing a recent trend from the field, the doctor says, "After pre-clinical trials with animals, it was observed that stem cell therapy could restore their ovarian and even testicular functions."

"After more phases of the trials with human cells, the results, if favourable, could lead to advancements in reproductive care," she concludes.

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Thalassemia is an inherited blood disorder that cannot be treated with medication. But stem cell therapy may be able to help. Know if stem cell therapy will work for the disease.

Written by Editorial Team | Updated : May 18, 2022 10:56 AM IST

Haemoglobin is the oxygen-carrying protein in the blood. In the absence or reduced amount of haemoglobin, the red cells do not survive for a long period and there is a diminished oxygen supply to the tissues causing a variety of symptoms. Thalassemia is an inherited blood disorder in which there is less haemoglobin than normal. There are two parts to the haemoglobin molecule alpha and beta. The disease is named based on the subunit that is not being made by the body alpha or beta-thalassemia.

Thalassemia runs in families; however, not everyone who has a dysfunctional gene for haemoglobin will have the symptoms of the disease. Those with moderate-severe disease experience symptoms such as breathlessness, weakness etc. (symptoms of anaemia), all associated with low levels of oxygen, from childhood. However, those with the mild disease might incidentally be diagnosed with thalassemia, mostly during investigations for other conditions or for anaemia.

Unfortunately, thalassemia cannot be prevented. Patients with the severe disease receive frequent blood transfusions, in an attempt to replenish a pool of healthy red blood cells. However, this procedure is associated with several issues such as iron overload that can deposit in different organs over time, immune system reactions, and risk of blood-related infections such as hepatitis, HIV etc. Folic acid is also prescribed to patients, which can help in the development of red blood cells.

Considering the issues with the conventional treatment of thalassemia, stem cell therapy can be an attractive choice for the condition. Allogeneic hematopoietic stem cell (blood stem cells) transplantation has been considered the only curative treatment for thalassemia. This treatment works by replenishing a healthy pool of blood-forming stem cells (master cells of the body) in the bone marrow consider the bone marrow as a factory of stem cells and specialized blood and tissue forming cells. However, considering that the source of stem cells is from a donor (usually a first-degree relative) because a patient's own blood-forming stem cells would be affected by the genetic mutation there are chances of certain side effects. One way to manage these issues is by the use of mesenchymal stem cells, which are known to have immune system regulating properties. By this, the rejection-related issues with hematopoietic stem cells as well as reduced immunity-related side effects can be handled efficiently. Considering that thalassemia is a disease that affects blood cells, mesenchymal cells (tissue forming cells) from the patient's own body are not affected.

Through this combined approach, a patient can achieve long-term remission from the symptoms of thalassemia without side effects. "Stem cell therapy for thalassemia is not a new treatment, only the approach by using a combination of stem cells to achieve holistic outcomes is novel.

(The article is contributed by Dr Pradeep Mahajan, Regenerative Medicine Researcher, StemRx Bioscience Solutions Pvt. Ltd., Navi Mumbai/Mumbai)

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Named for their ability to branch out to become cells that build multiple kinds of tissue, mesenchymal stem cells (MSC) and mesenchymal stromal cells appear in embryos and adult bone marrow, respectively. In 2019 scientists suggested redefining the MSC acronym as medicinal signaling cells, because the therapeutic cells usually come from bone marrow rather than the mesenchymea part of embryos. In this article well refer to all these similar cell types as stem cells.

Twenty years ago biologists had successfully developed stem cells into cartilage, tendon, heart, bone, and other kinds of tissues in their laboratoriesspurring hope for unprecedented tissue repair therapies in humans and animals.

Scientists now know stem cells use a very different healing mechanism than previously suspected, Oosterlinck says. In fact, recent research has revealed its not what these cells become that matters, but what they doand, more specifically, how they do it, in large part through a process known as paracrine signaling.

Basically, theres a lot of crosstalk that happens between stem cells and the injured cells, Schnabel says. That crosstalk seems to recruit special cells within the injured tissue called progenitor cellsand those appear to develop into the original local tissue cells, such as tendon cells.

Some research groups are looking at ways to predifferentiate cells in a laboratorypreparing them to go into tendon versus cartilage tissue, for exampleto help encourage them to be more effective in their therapeutic environment, Oosterlinck says.

Meanwhile, other research teams are showing how stem cells trigger specific cytokines (cell-signaling proteins) and growth factors that contribute to better tissue healing, he says.

The cells also encourage vascularization, says Schnabel. They actually bring blood vessels into the area, promoting angiogenesis, she says.

These recent discoveries about stem cell functions are major breakthroughs, says Schnabel. Her team currently focuses on optimizing the use of these cells. One thing theyre homing in on is dosing, which has always been complex, especially in horses, because its impossible, she says, to achieve the per-pound dose of cells recommended in human medicine.

Theyre also fine-tuning the question of treatment timing, she says. Traditionally, clinicians have treated horses with stem cells once the initial inflammatory response from the injury subsides. The idea was that you dont want to cause more inflammation, potentially, and have an even lamer horse, and you dont want the stem cells to get killed by the inflammation, she explains.

Ultimately, that might not be the right approach. All the studies weve been doing actually suggest the opposite, that having them in an inflammatory environment is good, because it further primes the cells to secrete the things you want, she says.

Then that also begs the question, if you get a horse after the time of acute inflammation, could you prime the cells first in the lab so that theyre ready to go when you put them in the horse? she adds. And thats been a major focus of our work. We have a lot of strong preliminary data suggesting that thats true.

Schnabels team, as well as other research groups, have looked specifically at tendon healing, revealing that horses treated with stem cells have significantly reduced re-injury rates, especially in the superficial digital flexor tendon (SDFT)which has a traditional re-injury rate of up to 70% in racehorses (RK Smith, et al.). This is huge, she says.

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Theglobal cell therapy marketsize was valued atUSD 8.1 billion in 2021and is estimated to reachUSD 23.9 billion by 2030, growing at a CAGR of 14.5% over the forecast period. The development of precision medicine and advancements in cellular therapies in context to their efficiency & manufacturing are expected to be major drivers for the market. Moreover, the development of stem cell banking facilities and resultant enhancement of stem cells production, storage, and characterization are also expected to improve the volumetric capabilities of the market at a global level, which is anticipated to directly translate into revenue for this market at a larger level. Ongoing technological advancements in the parent and ancillary markets for stem and non-stem cells usage are expected to reinforce the demand over the forecast period. There are fewer commercialized cellular therapy products in the current market than the number of research products. This is partly due to stringent regulations and the high cost of stem cells.

Cell lines, such as Induced Pluripotent Stem Cells (iPSC) and human Embryonic Stem Cells (hESC) are recognized as having high growth potential; as a result, many research entities and companies are making significant investments in R&D pertaining to iPSC- and hESC-derived products.

Pricing of stem cell transplantation varies from region to region. For instance, the cost of transplantation in the U.S. is higher than that in Germany or China. In March 2018, Alofisel by TiGenix received approval for marketing in Europe. This was the first allogeneic stem cell therapy to be approved in Europe. Furthermore, revenue for certain products varies for the country; for instance, products like INVOSSA received approval for marketing in Korea but have yet to receive marketing authorization in the U.S. Growth is also influenced by the commercialization of unauthorized stem cell treatments revenue generation.

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Global Cell Therapy Market Definition

Therapy in which viable cells are injected, grafted, or implanted into a patient to effectuate a medicinal effect is known ascell therapy; for instance, In immunotherapy, T-cells capable of fighting cancer cells via cell-mediated immunity are transplanted, and stem cells are grafted to regenerate diseased tissues.

Cellular therapies hold a great therapeutic promise across various clinical applications. This has resulted in substantial global investments in research and their clinical translation. Rapid advances in stem cell research have the potential to fulfill the unmet demand of pharmaceutical entities, biotech entities, and doctors in disease management. Several unknown therapies are in clinical development.

Furthermore, government and private funding agencies are constantly offering grants to support projects at various stages of clinical trials, increasing the number of ongoing clinical trials.

Research on human embryonic stem cells is ethically controversial. Harvesting embryonic stem cells involves the destruction of human embryos, raising a moral concern. In addition, stringent regulations for obtaining Intellectual Property Rights (IPR) for products or materials used in research are major restraints for commercializing these services. Ethical approval should be obtained to store cell lines and tissues in biorepositories to avoid the usage of tissue for illegal purposes or to identify proxy diseases to claim insurance. Moreover, controversies surrounding the use of embryonic stem cells for research impede the market growth in several regions

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The study categorizes the cell therapy market based on use type and therapy type at the regional and global levels.

The analysis of the cell therapy market is based on the use of stem cells for clinical and research purposes. The research-use segment dominated the market for the global cell therapy market and accounted for the largest revenue share of 58.3% in 2021. Currently, cell therapies (stem & non-stem cells) are majorly being used for research projects, which in turn, has led to a large revenue share of this segment in 2021. Cell-based therapies are all possibilities for the replacement, repair, restoration, and regeneration of damaged tissues, cells, and organs. As an alternative to traditional treatment strategies, researchers are investing heavily in developing effective and safe cell-based treatments.

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As per the CGT Catapult database of clinical trials, 59 cell and gene therapy trials are ongoing in the UK. Out of all therapeutic areas, oncology has the highest number of ongoing clinical trials. T cells, CD34+ and CD133+ stem cells, mesenchymal stem/stromal cells are some predominantly employed cell types for clinical investigation. Neural cells, bone marrow mononuclear cells, fibroblasts, cornea cells, antigen-presenting cells, epithelial cells, and chondrocytes are some other cells that are being explored for the development of cell therapies.

Asia Pacificaccounts for the highestCAGR during the forecast period

Based on the regions, the global cell therapy market has been segmented across North America, AsiaPacific, Europe, South America, and the Middle East & Africa.In the Asia Pacific, the market for cell therapy is anticipated to witness a lucrative growth rate of 15.5% over the forecast period. Advancements in stem cell therapy in Asian countries are observed to be better than those in the U.S. This has resulted in Asia leading stem cell research. Several stem cell consortiums in Asian countries aim to ensure coordinated and focused R&D programs. Moreover, patients from western countries migrate to Asian countries for treatment, owing to the flexible legal framework.

Companies from Japan, South Korea, India, China, Taiwan, Singapore, and the rest of Asia were active participants in the conference. In addition, the large regional population and untapped potential present in the region have resulted in global firms entering the market. Moreover, this region offers relatively inexpensive manufacturing & operating units for conducting research. These factors are expected to play a major role in expanding the stem cell market in this region.

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The cell therapy market is mildly concentrated in nature with few numbers of global players operating in the market such as Kolon TissueGene, Inc., Anterogen Co., Ltd., JCR Pharmaceuticals Co., Ltd., Castle Creek Biosciences, Inc., MEDIPOST, Osiris Therapeutics, Inc., PHARMICELL Co., Ltd, Tameika Cell Technologies, Inc., Cells for Cells, NuVasive, Inc., Vericel Corporation, and Celgene Corporation

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Cell Therapy Market Status and Size Report 2030 The Daily Vale - The Daily Vale

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personalized-cell-therapy-market

Global Personalized Cell Therapy Market is growing at a High CAGR during the forecast period 2022-2028. The increasing interest of the individuals in this industry is that the major reason for the expansion of this market and This has brought along several changes in This report also covers the impact ofCOVID-19on the global market.

The latest research report, titled Personalized Cell TherapyMarket Added by Market Info Reports, provides the reader with a comprehensive overview of the Personalized Cell Therapy Industry and familiarizes them with the latest market trends, industry information, and market share. The report content includes technology, industry drivers, geographic trends, market statistics, market forecasts, producers, and raw material/equipment suppliers. Global Personalized Cell Therapy market size was xx million US$ and it is expected to reach xx million US$ by the end of 2028, with a CAGR of XX between 2022 and 2028.

Personalized Cell Therapy Market competition by top manufacturers as follow:Novartis AG, Vericel Corporation, Bellicum Pharmaceuticals, MolMed SpA, Cytori Therapeutics Inc, Gilead Sciences, Inc, Celgene Corporation, Bluebird Bio, Aurora Biopharma Inc, Saneron CCEL Therapeutics?Inc, Kuur Therapeutics, MediGene AG, Sangamo Therapeutics and More

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The global Personalized Cell Therapy market has been segmented on the basis of technology, product type, application, distribution channel, end-user, and industry vertical, along with the geography, delivering valuable insights.

Market split by Type, can be divided into:By Cell TypeHematopoietic Stem CellSkeletal Muscle Stem Cell/Mesenchymal Stem Cells/LymphocytesBy TechniquePlatelet Transfusions/Bone Marrow Transplantation/Packed Red Cell Transfusions/Organ Transplantation

Market split by Application, can be divided into:Cardiovascular DiseasesNeurological DisordersInflammatory DiseasesDiabetesCancer

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Market segment by Regions/Countries, this report covers:North AmericaEuropeChinaRest of Asia PacificCentral & South AmericaMiddle East & Africa

Years Considered to Estimate the Market Size:History Year: 2015-2019Base Year: 2019Estimated Year: 2022Forecast Year: 2022-2028

Major factors covered in the report:

Detailed TOC of Personalized Cell Therapy Market Report 2022-2028:Chapter 1: Personalized Cell Therapy Market OverviewChapter 2: Economic Impact on IndustryChapter 3: Market Competition by ManufacturersChapter 4: Production, Revenue (Value) by RegionChapter 5: Supply (Production), Consumption, Export, Import by RegionsChapter 6: Production, Revenue (Value), Price Trend by TypeChapter 7: Market Analysis by ApplicationChapter 8: Manufacturing Cost AnalysisChapter 9: Industrial Chain, Sourcing Strategy and Downstream BuyersChapter 10: Marketing Strategy Analysis, Distributors/TradersChapter 11: Market Effect Factors AnalysisChapter 12: Personalized Cell Therapy Market ForecastContinued

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The analysis objectives of the report are:

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Personalized Cell Therapy Market 2022 Strategic Analysis, Growth Drivers, Industry Trends, Demand and Future Opportunities till 2028 |Novartis AG,...

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SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--May 24, 2022--

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that new data from clinical trials of 18 approved and investigational medicines across more than 20 cancer types will be presented at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting, which will be held June 3-7, 2022. Genentech and its partners will present clinical studies across medicines, comprehensive genomic tests, and real-world data at this years meeting.

At ASCO this year, progress from our portfolio, partnerships and collaborations showcase our commitment to advance innovation in cancer care, said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. Were especially pleased to present data from our broad hematology portfolio, including pivotal data for glofitamab, a potential first-in-class bispecific antibody that may improve the lives of people with heavily pre-treated aggressive lymphoma.

Focusing on improving outcomes in non-Hodgkin lymphoma

New and updated data in non-Hodgkin lymphoma will be presented at ASCO. This includes pivotal data from the Phase II NP30179 study investigating glofitamab, an investigational CD20xCD3 T-cell engaging bispecific antibody, in heavily pre-treated patients with diffuse large B-cell lymphoma (DLBCL). DLBCL is an aggressive form of lymphoma, where as many as 40% of patients will relapse, at which point treatment options are limited and survival is shortened. Glofitamab is part of Genentechs broad bispecific antibody development program, which may offer a new immunotherapy-based approach to tackle a range of blood cancers. It is being investigated in several clinical trials including the STARGLO Phase III study, evaluating glofitamab in combination with gemcitabine and oxaliplatin (GemOx) versus MabThera/Rituxan (rituximab) in combination with GemOx in autologous stem-cell transplant ineligible relapsed or refractory DLBCL. In addition, key findings from an analysis of the Asia subpopulation from the pivotal Phase III POLARIX study investigating Polivy (polatuzumab vedotin) in combination with MabThera/Rituxan plus cyclophosphamide, doxorubicin and prednisone (R-CHP) in people with newly diagnosed DLBCL will be featured. Polivy plus R-CHP is the first treatment regimen to significantly improve outcomes in previously untreated DLBCL in more than 20 years, potentially transforming treatment for people with this disease.

Driving innovation in personalized cancer care

More than 20 new pieces of research from partnerships with Foundation Medicine will be presented, which continue to support innovation as well as progress in personalized cancer care. This includes new data from the Phase II Profiler02 study,* which investigates the use of a comprehensive genomic profiling testing panel from Foundation Medicine, with the aim of informing possible treatment decisions for patients based on their tumors unique genomic information.

Data from the imCORE network

Additionally, three abstracts from the Immunotherapy Centers Of Research Excellence (imCORE) Network will be presented at ASCO: a Phase I study** investigating autogene cevumeran (an mRNA-based individualized neoantigen-specific immunotherapy [iNeST]***) in the adjuvant setting of pancreatic ductal adenocarcinoma; a data mining study** evaluating intermediate endpoints for survival in metastatic breast cancer in the real-world setting; and a study identifying mechanisms of acquired resistance to immune checkpoint blockade.**

imCORE is an academic-industry network for scientific collaboration. Established by Genentech and connecting experts from 26 leading institutions around the globe, imCORE is committed to advancing and accelerating cancer immunotherapy research. imCORE is an example of Genentechs dedication to collaborating with the global cancer community to further understand cancer biology and immunology, help inform the development of potential future treatment, and transform patients lives.

Genentechs data presented at ASCO will feature its efforts to drive innovation and commitment to health equity through delivery of pioneering medicines and personalized cancer care that together improve outcomes for every patient while reducing the cost to society, inclusive clinical trials that remove barriers to participation, partnerships that multiply our ability to address challenges in cancer care, and bringing innovation into earlier stages of disease to maximize a chance of cure.

Overview of key presentations featuring Genentech medicines

Medicine

Abstract title

Abstract number

Blood cancer

Glofitamab

Glofitamab in patients (pts) with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) and 2 prior therapies: Pivotal Phase II expansion results

#7500

Mosunetuzumab

CELESTIMO: a Phase III trial evaluating the efficacy and safety of mosunetuzumab plus lenalidomide versus rituximab plus lenalidomide in patients with relapsed or refractory follicular lymphoma who have received 1 line of systemic therapy

#TPS7588

Polivy

Asia subpopulation analysis from the Phase III POLARIX trial

#7558

Initial safety run-in results of the Phase III POLARGO trial: polatuzumab vedotin plus rituximab, gemcitabine, and oxaliplatin in patients (pts) with relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL)

#7551

Lung cancer

Tiragolumab

SKYSCRAPER-02: primary results of a Phase III, randomized, double-blind, placebo-controlled study of atezolizumab (atezo) plus carboplatin plus etoposide (CE) with or without tiragolumab (tira) in patients (pts) with untreated extensive-stage small cell lung cancer (ES-SCLC)

#LBA8507

Breast cancer

Giredestrant

Neoadjuvant giredestrant (GDC-9545) plus palbociclib (P) versus anastrozole (A) plus P in postmenopausal women with estrogen receptor-positive, HER2-negative, untreated early breast cancer (ER+/HER2 eBC): final analysis of the randomized, open-label, international Phase 2 coopERA BC study

#589

Inavolisib

Long-term safety of inavolisib (GDC-0077) in an ongoing Phase 1/1b study evaluating monotherapy and in combination (combo) with palbociclib (palbo) and/or endocrine therapy in patients (pts) with PIK3CA-mutated, hormone receptor-positive/HER2-negative (HR+/HER2) metastatic breast cancer (BC)

#1052

Tumor agnostic treatment and personalized healthcare

Rozlytrek

Efficacy/safety of entrectinib in patients (pts) with ROS1-positive (ROS1+) advanced/metastatic NSCLC from the Blood First Assay Screening Trial (BFAST)

#LBA9023

Rozlytrek

Trial in progress: a randomized Phase 3 study of entrectinib vs crizotinib in patients (pts) with locally advanced/metastatic ROS1 fusion-positive (fp) NSCLC with or without baseline CNS metastases (mets)

#TPS9141

Comprehensive genomic profiling

(IIS, Centre Lon Brard)

Increasing targeted therapy options for patients with relapsed cancer with broader somatic gene panel analysis from the primary tumor: The Profiler02 randomized Phase II trial*

#3130

Comprehensive genomic profiling

Clinical and genomic characteristics of patients with durable benefit from immune checkpoint inhibitors (ICI) in advanced non-small cell lung cancer (aNSCLC)

#9048

Comprehensive genomic profiling

ctDNA Shed as a Tool to Select Immune Checkpoint Inhibitors (ICPI) with or without Chemotherapy for Patients (pts) with advanced Non-small Cell Lung Cancer (aNSCLC)

#9045

Comprehensive genomic profiling

Trial in progress: LCMC LEADER Neoadjuvant Screening Trial: LCMC4 Evaluation of Actionable Drivers in Early Stage Lung Cancers

#TPS8596

Real world data

A real world (rw) evidence study quantifying the clinical value of multi-gene testing in early-stage lung adenocarcinoma (LUAD)

#8525

Real world data

Real world analysis of quantitative MET copy number (CN) as a biomarker in advanced NSCLC (aNSCLC)

#9123

Real world data

Ancestry-based differences in gene alterations in non-small cell lung cancer: real-world data using genetic ancestry analysis

#9125

imCORE,

ISR, Genentech

Identifying mechanisms of acquired immune escape from sequential, paired biopsies**

#2519

imCORE

ISR, Dana-Farber Cancer Institute

Real-World Progression-Free Survival (rwPFS) and Time to Next Line of Therapy (TTNT) as Intermediate Endpoints for Survival in Metastatic Breast Cancer: A Real World Experience**

#6520

imCORE

ISR, Memorial Sloan Kettering Cancer Center

Phase I Trial of Adjuvant Autogene Cevumeran, an Individualized mRNA Neoantigen Vaccine, for Pancreatic Ductal Adenocarcinoma**

#2516

* IIS, investigator-initiated study

** ISR, institution-sponsored research

*** jointly developed by Genentech and BioNTech

About Polivy (polatuzumab vedotin-piiq)

Polivy is a first-in-class anti-CD79b antibody-drug conjugate (ADC). The CD79b protein is expressed specifically in the majority of B cells, an immune cell impacted in some types of non-Hodgkins lymphoma (NHL), making it a promising target for the development of new therapies. Polivy binds to CD79b and destroys these B cells through the delivery of an anti-cancer agent, which is thought to minimize the effects on normal cells. Polivy is being developed by Genentech using Seagen ADC technology and is currently being investigated for the treatment of several types of NHL.

Polivy U.S. Indication

Polivy is a prescription medicine used with other medicines, bendamustine and a rituximab product, to treat diffuse large B-cell lymphoma in adults who have progressed after at least two prior therapies.

The accelerated approval of Polivy is based on a type of response rate. There are ongoing studies to confirm the clinical benefit of Polivy.

Important Safety Information

Possible serious side effects

Everyone reacts differently to Polivy therapy, so its important to know what the side effects are. Some people who have been treated with Polivy have experienced serious to fatal side effects. A patients doctor may stop or adjust a patients treatment if any serious side effects occur. Patients must contact their healthcare team if there are any signs of these side effects.

Nerve problems in arms and legs: This may happen as early as after the first dose and may worsen with every dose. If a patient already has nerve pain, Polivy may make it worse. The patients doctor will monitor for signs and symptoms, such as changes in sense of touch, numbness or tingling in hands or feet, nerve pain, burning sensation, any muscle weakness, or changes to walking patterns

Side effects seen most often

The most common side effects during treatment were:

Polivy may not be for everyone. A patient should talk to their doctor if they are:

These may not be all the side effects. Patients should talk to their healthcare provider for more information about the benefits and risks of Polivy treatment.

Report side effects to the FDA at (800) FDA-1088 or http://www.fda.gov/medwatch. Report side effects to Genentech at (888) 835-2555.

Please visit http://www.Polivy.com for the full Prescribing Information for additional Important Safety Information.

About Tecentriq (atezolizumab)

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Forward-looking Statements

Inadequate capital and barriers to raising the additional capital or to

Litigation with or legal claims and allegations by outside parties; and

Insufficient revenues to cover operating costs.

The Company is expanding its efforts to attract and cultivate collaborativepartners to accelerate its product development efforts, harnessing itsmanufacturing platform and tissue processing platforms. The R&D collaborationsare to discover, develop, and commercialize cellular therapies, laboratoryproducts and combinations thereof with synergistic technologies to createregenerative medicine applications and develop new intellectual property.

1. The Company filed its first Investigational New Drug Application (IND) with

the US Food and Drug Administration (FDA) for the ATCELL cellular therapy

product. The IND filing is titled "ATCell Expanded Autologous Adipose Derived

Mesenchymal Stem Cells deployed via Intravenous Infusion for the Treatment of

Post-Concussion Syndrome (PCS) in Retired Athletes and Military Personnel",

File number 19089, which was approved by the FDA on September 17, 2020. The

Company intends to invite additional developers of cellular therapies to

initiate additional arms of the clinical study focused on the use of ATCELL

for use in systemic inflammatory response relief for patient suffering from

systemic diseases. A number of these additional study targets have been

identified and ongoing discussions support the Company's belief that clinical

investigations can be developed and rapidly added upon completion of the new

2. DMD - The Company has completed the protocol for the treatment of Duchene

Muscular Dystrophy and is in final discussions with its Collaborative partner,

to select the principal investigator (PI) and clinical trial site selection.

3. Long COVID - The Company has completed the protocol for treatment of Long

COVID and is currently finalizing its FDA filings. We have completed, along

with a government partner the clinical protocol for a new Investigational New

Drug (IND) application to be filed with FDA within the next 90 days for Long

COVID. According to the Centers for Disease Control and Prevention,

"post-COVID conditions can be considered a lack of return to a usual state of

health following acute COVID-19 illness." In the US, following COVID recovery,

it is reported that up to 30% of those afflicted, diagnosed, or treated for

COVID-19 have continuing symptoms and medical complications following recovery

4. Wound Healing - the creation of topical applications and ingredients used by

physicians in the wound care and cosmetic industries as well as therapeutic

cellular applications and bio-materials development. An initial pilot study

involving a minimum of 10 participants for the assessment of its autologous

tissue products for the wound healing market is underway. The Company is

combining its tissue products, which do not require FDA approval, with current

standard-of-care methods to accelerate and improve the healing of diabetic and

5. ATGRAFT - products include adipose tissue and cell sample processing and

storage as a form of personal "bio-insurance", and adipose tissue (fat)

storage for cosmetic fat engraftment procedures. High demand for pure and

natural aesthetics in fast growing cosmetic industry with non-FDA required

Tissue Processing and Storage Services:

Laboratory Products; Culture Medium, and Manufacturing Services

The Company has created several versions of its ACSelerate cell culture mediaincluding:

ACSelerate-MAX - xeno serum free cell culture media,

ACSelerate-SFM - animal serum free cell culture media,

ACSelerate-LSM - low FBS (0.05%) cell culture media,

ACSelerate-CY- for differentiation of ATCELLinto chondrocytes (ATCELL-CY),

ACSelerate-OB- for differentiation of ATCELLinto osteoblasts (ATCELL-OB)

ACSelerate-AD - for differentiation of ATCELLinto adipocytes (ATCELL-AD)

ACSelerate-MY- for differentiation of ATCELL into myocytes (ATCELL-MY)

ACSelerate-CP- non-DMSO (Dimethyl Sulfoxide) cellular cryopreservation media

ACSelerate-TR- sterile transportation medium designed to maintain the

viability of the tissue during the shipment of adipose tissue to our processing

International Licensing Program - COVID RISK FACTOR

(https://www.transparencymarketresearch.com/pressrelease/stem-cells-market.htm)

China

Thailand

Japan

Collaborations / Partnering Opportunities / Acquisitions

WRNMMC

WRNMMC is part of The Military Health System (MHS) which is the enterprisewithin the United States Department of Defense that provides health care toactive duty, Reserve component and retired U.S. Military personnel and theirdependents.

To ensure that all active and reserve medical personnel in uniform are trained

and ready to provide medical care in support of operational forces around the

world.

To provide a medical benefit commensurate with the service and sacrifice of

more than 9.5 million active-duty personnel, military retirees, and their

families.

The MHS also provides health care, through the TRICARE health plan, to:

Active-duty service members and their families,

Retired service members and their families,

Reserve component members and their families,

Surviving family members,

Medal of Honor recipients and their families

Some former spouses, and

Others identified as eligible in the Defense Enrollment Eligibility Reporting

Intellectual Property

Systems and Methods for the Adipose Tissue Digestion U.S. Serial No.Digestion of Adipose Tissue Laboratory Processing 13/646,647 filed OctoberSamples Obtained From a Client Methods

Additionally, the Company has in-licensed the following IP:

Wound healing compositions and Protein Genomics andmethods using tropoelastin and American CryoStem USPTO: #6,808,707lysyl oxidase

Market Size and Opportunities

Regenerative Medicine Market

Development of Regional U.S. Markets

Physician Network

Development of International Markets

Corporate Information

Available Information

Results of Operations - Three Months

The Company's revenue for the quarter ended March 31, 2022, increased to $31,935versus $1,935 in the same period of Fiscal 2021.

Liquidity and Capital Resources

Accounts Receivable decreased to $65,680 at March 31, 2022 from $78,782 atSeptember 30, 2021.

There was no significant impact on the Company's operations as a result ofinflation for the six months ended March 31, 2022.

The Company leases Equipment at its laboratory from NFS Leasing, Inc. Leasepayments are $2,993.62 per month for eighteen (18) months. The final leasepayment is scheduled for January 1, 2023. When the final payment is made, theCompany will own the equipment. See Note 11 . Leases in the FinancialStatements.

The Company was not party to any litigation against it and is not aware of anylitigation contemplated against it as of March 31, 2022. See also LegalProceedings below.

From time to time the Company takes advances makes principal payments on thenote. During the six months ended March 31, 2022, the Company was advanced$1,729 and made payments of $18,000 on the note.

The principal balance of the Note is $131,505 at March 31, 2022 and 147,775 atSeptember 30, 2021.

Terms of the Series A Voting Convertible Preferred Shares are as follows:

1. Each Series A Share is convertible into 20 shares of American CryoStem common

stock $0.001 par value, subject to any recapitalization event.

2. Stated annual dividend of $0.20 per share payable quarterly in cash or stock

at the discretion of the Company's Board of directors.

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Case Overview:

Initial Presentation (Jan 2017)

A 64-year-old man is found to have a firm bilateral prostate nodule of 1.8 mm on his routine physical exam

Clinical workup

PSA 109.1 ng/mL

Family history of prostate cancer (father, uncle)

Transrectal ultrasound (TRUS)-guided biopsy of the prostate confirms advanced adenocarcinoma of the prostate and Gleason score of 8 (4 + 4)/Grade Group 4

MRI is negative for pelvic LN involvement but positive for one 1.1-cm mediastinal supraclavicular LN (T2bN0M1a)

His ECOG PS is 1

Germline multigene testing of biopsy specimen revealed a BRCA2 mutation

Initial Treatment (starting Feb 2017)

Patient was started on leuprolide and abiraterone; scheduled for physical exam, PSA assessment, and imaging every 3 months.

By the second follow-up visit (6 months after initiating treatment; August 2017), PSA levels declined to 2.1 ng/mL and prostate nodule size was 1.4 mm.

Patients disease remained stable through August 2018 (18 months of treatment).

21- and 24-month Follow-up Notes (November 2018, February 2019)

Patients PSA levels increased to 46.9 ng/mL in 11/2018 and 73.7 ng/mL in 2/2019.

MRI revealed that the size of the existing positive LN increased to 1.3 cm, and revealed a new, faintly positive 0.9-cm para-aortic LN.

Given the recent findings and the patients known BRCA2 mutation status, the patient and clinician decide to initiate olaparib 300 mg BID.

Neal Shore, MD, FACS: Lets review the utility of genetic testing in patients with prostate cancer. This is a really important topic. Lets talk about the guidelines for testing. I think most would agree that the NCCN [National Comprehensive Cancer Network] has done a good job in evolving their recommendations for both germline and somatic testing. Right now, in 2022, its really not who do you test, whos newly diagnosed, its who dont you test for germline alterations. The answer is, if youre in grade group 1 or grade group 2, so Gleason score 6, or 3 plus 4, and you have no significant family history of cancer, the NCCN says dont get germline testing. Everyone else, grade group 1 and 2 with a significant family history of cancerbreast, ovarian, colorectal, prostate, male breast, upper tract, urothelial, melanoma, skin cancer, pancreatic canceryou would get germline testing. Certainly, anybody whos high-risk localized, you get germline testing. And anyone who has metastatic disease, de novo or recurrent, you get germline testing.

We presented some data, we had a podium presentation of 1000 patients studied prospectively. We presented it at ASCO [American Society of Clinical Oncology annual meeting] 2021 and at AUA [American Urological Association meeting] 2021. We basically came to the conclusion that we think all patients should be tested regardless of their grade group or their family history, because oftentimes family history is not reliable. Its important to get when it is reliable, but it can be unreliable. And some patients and their caregivers and their partners just dont know their family history. Some people are adopted. Then theres always the chance that the histopathology report can have variable or different interpretations, so a 3 plus 4 might actually be a 4 plus 3. I even see second opinions where a 3 plus 3 has turned into a 4 plus 3. Or a 3 plus 4 can become a 4 plus 4. Im a believer in democratizing germline testing to make it simpler. Its gotten less expensive. Thats subjective, but it used to be in the thousands-of-dollars range. Now its only a few hundred dollars, so I think anyone diagnosed with localized prostate cancer, my personal opinion is they should get germline testing.

Now, somatic testing per the NCCN recommendation is to get it when you are resistant, so when you are castration resistant. Its important because if youre germline negative, you might pick up another 50% of patients with HRR [homologous recombination repair] mutations. We saw that about 28%, 30% in some centers have HRR mutations, and we saw that in the PROfound trial. Other trials and studies have corroborated that. For newly diagnosed, youre probably going to see positive germline alterations in the HRR category of about 10% to 12%. So its important if youre germline negative that you dont stop there once the patient develops resistance, that you get either the archival tissue, prostate biopsy tissue, the prostatectomy specimen. Or you can get metastasis-directed biopsies. If you cant get tissue or you cant do a biopsy, then you can what we describe as a liquid biopsy, and you look for circulating DNA alterations.

This then opens up a field of opportunity of clinical utility because we now have level 1 evidence for the use of PARP inhibitors. We also have level 1 evidence for the use of a checkpoint inhibitor when theres MSI [microsatellite instability]-high. We also have multiple trials ongoing with other alterations, such as ATM, PTEN loss, other alterations where were looking in a clinical trial landscape to come up with additional therapeutics. Then theres the importance of cascade family testing. If theres a germline alteration, youd want to certainly know to inform the patients children, siblings, nieces and nephews. It would be great to be able to pick up a very early ovarian, breast or prostate cancer, pancreatic cancer, colorectal cancer, and cure that patient at its earliest stages.

How do the test results impact patient management? Well, exactly, if you have an alteration, its a pathogenic variant as opposed to a variant of uncertain significance. It can lead to approved therapies as Ive described. It could lead to more vigilant surveillance or possibly an active intervention for localized disease. Or it certainly could lead to an approved indication of a therapy when the patient reaches that point in their journey.

Transcript edited for clarity.

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The Utility of Genetic Testing in Patients with Prostate Cancer - Urology Times

Recommendation and review posted by Bethany Smith

MarketResearch.biz has released the report Genetic Testing Services Market By Type, Application End-Use Industry And Region-Global Forecast to 2022-2031. The Global Genetic Testing Services market is expected to reach 103Bn, with a CAGR of 5.99% between 2022 and 2031. This report presents the strengths and opportunities, as well as future business risks, and provides a comprehensive overview of global market conditions using COVID-19 results.

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Laboratory Corporation of America Holdings, Quest Diagnostics Incorporated, Genomic Health, Inc., NeoGenomics Laboratories, Inc., Eurofins Scientific, Ambry Genetics, Illumina, Inc

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Prenatal TestingNew Born ScreeningPredictive and Presymptomatic TestingPharmacogenomic TestingOthers

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Hospital based LaboratoriesDiagnostic laboratoriesSpecialty ClinicsOthers

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Genetic Testing Services Market Size 2022 With 5.99% CAGR : Recent Industry Developments With Top Players and Forecast Up to 2031 - Taiwan News

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