A Cure for Hemophilia? BioMarin Attempts to Stop the Bleeding with a Single Shot

By Matthew Rojas, Biotech Analyst

Most people recall learning about hemophilia from the history books. Specifically, Queen Victoria of England, who ruled from 1837-1901, was a suspected carrier of the hemophilia B trait that causes the infamous, potentially fatal bleeding disorder. Since then, hemophilia has commonly been referred to as a royal disease due to its prevalence in various royal families throughout England, Germany, Russia, and Spain during the 19th and 20th centuries.

In the United States, there are approximately 20,000 people with hemophilia, and an estimated more than 400,000 individuals have the disorder worldwide. In addition to hemophilia B, there is also hemophilia A. The difference between the two conditions lies in which clotting protein is defective or missing for hemophilia B it is factor IX and for hemophilia A, factor VIII. Nevertheless, the symptoms of both variations of hemophilia are the same and range in severity from excessive bleeding only after an injury to frequent, spontaneous bleeding.

Presently, people with hemophilia A or B need infusions of the respective clotting protein two to three times per week. Not to mention, the weekly injections do not stop all bleeding episodes. Going to the doctor this frequently is extremely time-consuming, making it inconvenient for most individuals. Hence, many people with hemophilia fail to receive adequate treatment for their condition, which puts them at great risk. There is a pressing need for a more efficient way to treat individuals with hemophilia this is where BioMarin comes to the rescue.

BioMarin is a California-based biotechnology company that focuses on rare diseases driven by genetic causes. Currently, they have something revolutionary in their clinical pipeline for patients suffering from hemophilia A: valoctocogene roxaparvovec or valrox. Unlike traditional methods for treating hemophilia, valrox does not require repeated injections to temporarily mitigate symptoms; valrox uses gene therapy and only requires a single infusion to cure hemophilia A patients. Yes, you read that right cure. Gene therapy is a complicated process that works by inserting genetic material, via a carrier or vector, into cells so that they can make a protein in this case, factor VIII. For valrox, the vector is AAV5; a concern arose because people with AAV5 antibodies are ineligible to receive valrox. However, BioMarin estimates that 80% of people with hemophilia A do not have AAV5 immunity, so this should not be a problem.

A cure almost seems too good to be true, but the data are clear. In BioMarins Phase III clinical trial, seven out of 16 hemophilia A patients exhibited required levels of factor VIII. The company submitted this data along with three years of Phase I/II data for FDA approval. The application is currently under priority review, and a decision is expected on August 21, 2020. Therefore, now is the perfect time to invest in BioMarin because its current stock price does not reflect the potential revenue from valrox in the near future.

According to Hank Fuchs, president, Global Research and Development at BioMarin, Valoctocogene roxaparvovec has the potential to be the first gene therapy to be approved in any type of hemophilia. In the gene therapy space, it is critical to be a first mover because once patients are treated, they are taken off the market. After all, people only need a single shot.

Some of BioMarins competitors include Pfizer and Sangamo Therapeutics SB-525 and Spark Therapeutics SPK-8011, both gene therapies for hemophilia A. However, SB-525 is still in the process of Phase III clinical trials, and Spark ran into trouble when one patient ended up in the hospital due to an immune reaction related to SPK-8011. On the other hand, valrox is safe, has already completed its clinical trials, and is currently under priority review by the FDA. Thus, BioMarin is on track to be the first mover.

To further ensure its dominance in the hemophilia A gene therapy space, BioMarin increased the number of doses its gene therapy facility could produce from 4,000 to 10,000. To put that increase in perspective, the company can now treat all of the hemophilia A patients in the United States in two years. If established as the first mover, BioMarin has sufficient capacity to quickly dose hemophilia A patients before other gene therapies are approved to go to market.

As stated above, the current treatments for hemophilia A are weekly, expensive injections of prophylactic FVIII. Patients are dependent on these injections for their entire lives, costing an estimated $700,000 to $750,000 per year. Also, many hemophilia patients have greater costs due to frequent hospital visits, procedures, various tests, etc.

One study analyzes the possible cost-effectiveness of valrox compared to traditional prophylactic FVIII injections. The results are astounding the average patient cost of valrox is an estimated $16.7 million, whereas the average patient cost of the prophylactic FVIII injections is an estimated $23.5 million. Therefore, valrox provides a reduction in costs of $6.8 million per patient, on average. Because valrox is cheaper and more effective, it is likely to become the dominant way that hemophilia A patients are treated.

Unlike many biotechnology companies, BioMarins stock (BMRN) has come out on top at the tail-end of the COVID-19 pandemic. Before the crisis, the company was trading at around $97.00, and now the share price has increased by about 10% to $106.00. This increase in share price is promising because if BioMarin can perform well in times of economic-downturn, imagine what they can do in times of economic health. The reason for this continued growth is likely because BioMarin has steady revenue streams from a diversified portfolio of products for rare diseases; in 2019 alone, the company generated nearly $1.7 billion in revenue from its product lines, a 13% increase compared to 2018. With the likely approval of valrox in late August, I expect that the stock price will increase even further.

Furthermore, BioMarin has solid financials across all of its first-quarter 2020 statements. As of its most recent balance sheet, BioMarin has a current ratio slightly above 1, indicating that it can cover its short-term debt obligations. Additionally, the company generated over $100 million in revenues in the first quarter, a 25% increase from the fourth quarter of 2019. Lastly, BioMarin ended the most recent quarter with an increase of about $40 million in cash, which shows that it can generate liquidity even in times of crisis. BioMarins financials are stronger than ever, allowing it to continually achieve success.

Hundreds of thousands of hemophilia patients around the world have an unmet need: a permanent treatment for their disorder. BioMarin meets that need. With the use of revolutionary gene therapy, BioMarin has developed valrox, a single infusion that will cure hemophilia A patients once and for all. Not only is valrox more effective than the leading treatments for hemophilia A, but it is also much cheaper, saving patients and payers millions of dollars. With BioMarin scheduled to be the first-mover in the hemophilia A gene therapy space, now is the critical time to invest before valrox stops the bleeding.

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Gene Therapy: Regal Profits From Curing "The Royal Disease"? - Sick Economics

Recommendation and review posted by Bethany Smith

Cancer isnt waiting for Covid-19 to go away. Neither is Karen Howley.

Diagnosed two years ago with advanced ovarian cancer, Howley started on a new experimental drug in mid-March, just as coronavirus case counts were soaring in Massachusetts. Her treatment, part of a clinical trial at Dana-Farber Cancer Institute in Boston, began with a four-week hospital stay, and since then, shes been returning every Monday for infusions.

While the study drug dripped into her body, she heard the hospital staff apprehensively discussing the coming surge of cases. Howley felt safe on a floor devoted to cancer patients, where there was no shortage of personal protective gear for the medical workers, but she still wiped down her tray each time a a meal was delivered to her bedside.

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Ambulance sirens wailing endlessly outside her window made her anxious. The hospitals no-visitor policy made her lonely. But Howley, who has faced her cancer with both humor and realism, never considered quitting the clinical trial.

I dont think it occurred to me, Howley, 56, said during an infusion appointment last week that she wryly called her spa day.

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Treatment for me is prolonging my life at this point. And if I do get Covid, I do.

Around the world, Covid-19 has disrupted all types of clinical trials, decreasing by 74% the number of new patients enrolling. In cancer, the number of new patients entering Phase 2 and 3 cancer trials in the U.S. plummeted by about 46% to 48% in the last two weeks of March, said Margaret Mooney, associate director of the Cancer Therapy Evaluation Program in the Division of Cancer Treatment and Diagnosis at the National Cancer Institute. By the last week of May and first week of June, the cliff wasnt so steep, moderating to a 25% to 30% decline.

Some medical centers put certain research trials on hold, stretched too thin by the needs of treating Covid-19 patients. Others continued their cancer trials by taking advantage of NCI-modified protocols allowing patient consent by phone or delivery of oral drugs to patients homes. Depending on where an individual site was located, they made local decisions that were best for their patients and their patient population in terms of clinical trials, Mooney said.

At Dana-Farber, Ursula Matulonis, chief of gynecologic oncology and Howleys oncologist, recalled patients feeling frightened and doctors feeling uncertain about exactly how they would carry on in the early days of the pandemic but no one ever doubted that they would.

We said, look, weve got to go in to see our patients because theyve got cancer. They want to continue to be treated in the same way, she said. We have a job to do and we have to continue to do that job.

Doing that job at Dana-Farber means patients are screened for symptoms when they enter the cancer center and at each step along the way. Howley answers the same set of questions Any fever? Any cough? Any contact with anyone who has Covid-19? when she has her vitals checked, gets her blood drawn, sees her doctor, receives her infusion.

Shes used to the waiting-room chairs zip-tied in opposite directions to keep single patients (no more friends or family) from getting too close. She expects to park her own car rather than turn it over to a valet. Because shes enrolled in a research trial, there are more blood samples taken for analysis and for tracking her response to the drug, but the entire visit moves along more quickly now, streamlined to reduce waiting times so no patient is exposed longer than necessary to other people.

Andrew Wagner, an oncologist who is leading Dana-Farbers efforts to keep patients safe and on treatment during Covid-19, said in consultation with study sponsors, some tissue biopsies were canceled, or for some patients chemotherapy was adjusted from every week to every three weeks. Physician visits to discuss imaging scans moved from in-person to video. Dana-Farber had zero telemedicine before March, but virtual visits now account for just under half of patient appointments, holding lessons for the future.

Its been hard in oncology, of course. Such a large part of what we do is the emotional care of patients and their families, Wagner said. Being able to hold someones hand is really hard to do through telemedicine, but certainly the video aspect of it is much better than just the telephone. Youre able to express yourself empathically.

Patient visits to Dana-Farber plunged by 40% in the course of one week in mid-March but chemotherapy appointments slipped by only 10% to 15% over that same week. Now doctors are encouraging patients to come back in. We think that its very safe here. We are certainly safer than in the grocery store, Wagner said. Cancer is not going to wait for Covid to go away.

Other cancer centers made similar adjustments. At the Ohio State University Comprehensive Cancer Center in Columbus, where close to 1,000 clinical trials are typically underway, Ohio Gov. Mike DeWines March 23 stay-at-home policy kept 200 research nurses and other staffers away from their duties. That meant only trials with a critical therapeutic outcome, extremely modest staffing needs, or time-sensitive enrollment targets continued, said Raphael Pollock, director of the cancer center.

Now that Ohios stay-at-home policy has been lifted and the research machinery is gearing up again, he expects trial participation to tick back up, too. Cancer didnt take time off, Pollock said. Well be quite busy by the mid- to late summer.

And at Memorial Sloan Kettering Cancer Center in New York City, the U.S. epicenter of the pandemic, no therapeutic trials were put on hold, but in-clinic volume in March and April did drop by about 75%. Telemedicine helped, said Paul Sabbatini, an oncologist and deputy physician-in-chief for clinical research. We and most centers have developed processes to rationally deal with the Covid risk as best we can so [clinical trials] can proceed now.

Now patients are coming back.

While it was prudent for patients to avoid the medical setting when the pandemic was at peak, enough time has elapsed that many of those patients clearly now have a benefit/risk ratio in favor of care, Sabbatini said. Clinical trials remain the only way we evaluate and ultimately approve new therapies for patients with cancer.

NCIs Mooney believes some good may come from adjustments made to ensure the safety of patients participating in studies and medical staff. But its still a work in progress, as hotspots rise and fall.

I think were learning more as we go along, she said. Some of the adaptations weve made have made all of us realize that perhaps there is better use we can make of technology telemedicine or technologies like that to take care of the patient. Thats a benefit to everyone, and they may be things that we can continue into the future once the public health emergency, as we all hope, has been resolved.

At Dana-Farber, Howley is enrolled in a Phase 1 trial of REGN4018, a bispecific antibody developed by the biotech company Regeneron. It grabs onto cancer cells at two points connected by a bridge. One side targets MUC16, a gene mutated in ovarian cancer and previously known as CA125 (which is still the name for the biomarker measured in diagnostic blood tests). The other side of the antibody binds to a T cell receptor that can then kill the cancer cell, the theory goes.

You realize this [Covid-19] is temporary and one day we will be back. For me, its like, I dont know how long I have.

When patients are hospitalized at the outset of the trial, which at this early phase is designed to test safety and dosing, its not an easy time for them with or without a pandemic. They are waiting for the drug to provoke their immune systems into killing their cancers. Howley felt savage pain across her abdomen and the wrath of a cytokine storm, the massive inflammatory response that also occurs in some Covid-19 patients whose immune systems go into overdrive.

We believe that the best antibodies you can get are the specific antibodies that travel to the sites of tumors. And thats what causes the abdominal pain, Matulonis, her oncologist, said.

From the beginning, Howleys treatment path has not been easy. After initial surgery to remove her tumor, she endured peritoneal delivery of the chemotherapy drug cisplatin directly to her abdomen, which was both painful and ultimately ineffective. She went on a standard drug called Doxil, but her cancer still progressed. Next she started a clinical trial that combined three drugs: one immunotherapy drug, one drug that blocks new blood vessel growth, and one PARP inhibitor that interferes with how cancer cells repair DNA damage. It was an aggressive regimen designed to expose the cancer to three agents it had never seen before, Matulonis said.

But one drug caused a bowel perforation, a known side effect. She continued to take the immunotherapy and the PARP inhibitor, but by November her cancer was progressing, measured by blood tests gauging her CA125 levels and imaging scans that spot metastasis.

The new trial, of the bispecific antibody, started in February.

I think for her, Ive always wanted to go beyond standard chemotherapy, Matulonis said. You can see that the tumor was a harder nut to crack. We really have to think outside the box to treat her.

Matulonis said Howley can stay on the current trial as long as she meets three conditions: She is benefiting from the drug, she is not having any significant toxicities, and she wants to continue. Howleys CA125 has hit four figures in the past. Before last weeks blood test, her last reading was 499. She was both nervous and eager to know the latest, though she tries not to put too much stock in the biomarker. The reading can vary with inflammation and the drug she is on causes inflammation, irritating one hip so much that she wants to ask if a cortisone shot would be allowed under the trials rules.

Except for the cancer, shell tell you shes healthy, and Matulonis agrees. Retired now from a career in client services, she lives with her husband in Sudbury, Mass., about a 40-minute drive to Boston. She walks three miles every morning, and she just got back to playing tennis. She ran the Falmouth Road Race last summer, astonishing a research nurse on her medical team who was volunteering on the sidelines.

For her visit last week, she wore a white, cowl-necked knit top port-friendly for blood draws and drug infusions through an opening high on her chest. Her lively blue eyes were set off by sparkly deep-blue eye shadow, her dark hair accented with blond highlights. Shes been the woman in the waiting room with no hair or eyebrows and knows how it feels when people look at you. Now she jokes about reluctantly giving up her fashion-coordinated cloth face mask for the fresh paper one Dana-Farber offers each patient upon check-in.

Howley has dual motivations for participating in cancer research. One is to help other women with ovarian cancer. Hopefully Im a piece of that puzzle thats going to give them a little insight, she said. They might have something here thats going to be so critical down the road for others.

Her other driving force is her 29-year-old daughter. She doesnt worry about their sharing BRCA1 or BRCA2 mutations her genetic tests were negative for those mutations but she is concerned about being a role model.

So much of my determination is just really providing an example to her, she said. Im not saying Ive got it down at all, but I try very hard to show her how to do it kind of gracefully. It doesnt mean Im going to do it. But I still try.

Cancer has already narrowed how she thinks about the future. Six months is as far out as shell plan these days, and Covid-19 has cramped her dreams of traveling to one of her favorite places, Marco Island in Florida. You realize this [Covid-19] is temporary and one day we will be back, Howley said. For me, its like, I dont know how long I have.

No one can tell her that, but she looks to Matulonis to see if her new CA125 number matches how good shes felt, even if she hit lousy on the tennis court.

The number is still moving in the right direction, Matulonis tells her: 259, down from 499 a month ago. That could mean her cancer burden is diminishing, Matulonis said, but cautioned that imaging scans will have to confirm it.

Howley knows that.

If it goes up 50 points, it doesnt necessarily mean anything. But at the same time, Im just blown away, she said. Today, its almost surreal to me, its going to take me a while to digest.

She is still elated as she climbs into the infusion chair for her next dose of the trial drug.

Maybe I better plan that trip.

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Cancer patients and doctors carry on with clinical trials during Covid-19 - STAT

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SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the Phase III IMpassion031 study, evaluating Tecentriq (atezolizumab) in combination with chemotherapy (Abraxane [albumin-bound paclitaxel, nab-paclitaxel]; followed by doxorubicin and cyclophosphamide) in comparison to placebo plus chemotherapy (including Abraxane), met its primary endpoint by demonstrating a statistically significant and clinically meaningful improvement in pathological complete response (pCR) for the treatment of people with early triple-negative breast cancer (TNBC), regardless of PD-L1 expression.

Triple-negative breast cancer remains an aggressive disease with high rates of recurrence, said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. Our goal in treating TNBC at its earliest stages is to provide people with the best chance for a future cure. Adding Tecentriq to chemotherapy now has the potential to help women with TNBC at multiple different stages of the disease.

In the study, fewer patients who received the Tecentriq combination as a neoadjuvant (before surgery) treatment had evidence of tumor tissue detectable at the time of surgery (known as pCR), regardless of PD-L1 expression, in comparison to the control arm. Neoadjuvant treatment may allow a doctor to quickly assess whether a medicine is working, and may also reduce a tumor's size so it is easier to surgically remove. pCR is a common measure of neoadjuvant treatment effect in breast cancer and can be assessed more quickly than traditional endpoints in early-stage breast cancer.

Safety for the Tecentriq combination appeared to be consistent with the known safety profiles of the individual medicines and no new safety signals were identified. Results of the IMpassion031 study will be presented at an upcoming medical meeting and will be discussed with global health authorities including the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA).

The IMpassion031 study is the second positive Phase III study from Genentech demonstrating the benefit of Tecentriq in TNBC, and the first Tecentriq study to demonstrate benefit in early TNBC. Tecentriq in combination with nab-paclitaxel is currently approved in more than 70 countries worldwide, including the U.S. and across Europe, for the treatment of adults with unresectable locally advanced or metastatic TNBC in people whose tumors express PD-L1 (IC1%).

Genentech has an extensive development program for Tecentriq, including multiple ongoing and planned Phase III studies across lung, genitourinary, skin, breast, gastrointestinal, gynecological, and head and neck cancers. This includes studies evaluating Tecentriq both alone and in combination with other medicines.

About the IMpassion031 study

The IMpassion031 study is a Phase III, multi-center, randomized, double-blind study evaluating the efficacy and safety of Tecentriq (atezolizumab) in combination with chemotherapy (Abraxane, [albumin-bound paclitaxel; nab-paclitaxel]; followed by doxorubicin and cyclophosphamide) in comparison to placebo plus chemotherapy, in people with previously untreated, early TNBC. The primary endpoint is pCR using the American Joint Committee on Cancer (AJCC) staging system in the intention-to-treat (ITT) population and in the PD-L1-positive population. Secondary endpoints include overall survival, event-free survival, disease-free survival and quality of life measures.

About Tecentriq (atezolizumab)

Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1. Tecentriq is designed to bind to PD-L1 expressed on tumor cells and tumor-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the re-activation of T cells. Tecentriq may also affect normal cells.

About triple-negative breast cancer

Breast cancer is the most common cancer among women worldwide. According to the American Cancer Society, close to 280,000 people in the United States will be diagnosed with invasive breast cancer, and more than 42,000 will die from the disease in 2020. Breast cancer is not one, but many diseases based on the biology of each tumor. In triple-negative breast cancer, tumor cells lack hormone receptors and do not have excess HER2 protein. Approximately 15 percent of breast cancers are triple-negative based on the results of diagnostic tests. It is an aggressive form of the disease with few treatment options.

Tecentriq U.S. Indications (pronounced t-SEN-trik)

Tecentriq is a prescription medicine used to treat adults with:

A type of bladder and urinary tract cancer called urothelial carcinoma.

Tecentriq may be used in patients with urothelial carcinoma if their bladder cancer has spread or cannot be removed by surgery, and if they have any one of the following conditions:

The approval of Tecentriq in these patients is based on a study that measured the amount of time until patients disease worsened. Continued approval for this use may depend on the results of an ongoing study to confirm benefit.

A type of lung cancer called non-small cell lung cancer (NSCLC).

Tecentriq may be used alone as the first treatment in patients with lung cancer if:

Tecentriq may be used with the medicines bevacizumab, paclitaxel, and carboplatin as the first treatment in patients with lung cancer if:

Tecentriq may be used with the medicines paclitaxel protein-bound and carboplatin as the first treatment in patients with lung cancer if:

Tecentriq may be used alone in patients with lung cancer if:

If a patients tumor has an abnormal EGFR or ALK gene, they should have also tried an FDA-approved therapy for tumors with these abnormal genes, and it did not work or is no longer working.

A type of breast cancer called triple-negative breast cancer (TNBC).

Tecentriq may be used with the medicine paclitaxel protein-bound in patients with TNBC when their breast cancer:

The approval of Tecentriq in these patients is based on a study that measured the amount of time until patients disease worsened. Continued approval for this use may depend on the results of an ongoing study to confirm benefit.

A type of lung cancer called small cell lung cancer (SCLC).

A type of liver cancer called hepatocellular carcinoma (HCC).

It is not known if Tecentriq is safe and effective in children.

Important Safety Information

The most important information about Tecentriq is:

Tecentriq can cause the immune system to attack normal organs and tissues and can affect the way they work. These problems can sometimes become serious or life-threatening and can lead to death.

Patients should call or see their healthcare provider right away if they get any symptoms of the following problems or these symptoms get worse.

Tecentriq can cause serious side effects, including:

Getting medical treatment right away may help keep these problems from becoming more serious. A healthcare provider may treat patients with corticosteroid or hormone replacement medicines. A healthcare provider may delay or completely stop treatment with Tecentriq if patients have severe side effects.

Before receiving Tecentriq, patients should tell their healthcare provider about all of their medical conditions, including if they:

Patients should tell their healthcare provider about all the medicines they take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

The most common side effects of Tecentriq when used alone include:

The most common side effects of Tecentriq when used in lung cancer with other anti-cancer medicines include:

The most common side effects of Tecentriq when used in TNBC with paclitaxel protein-bound include:

The most common side effects of Tecentriq when used in hepatocellular carcinoma with bevacizumab include:

Tecentriq may cause fertility problems in females, which may affect their ability to have children. Patients should talk to their healthcare provider if they have concerns about fertility.

These are not all the possible side effects of Tecentriq. Patients should ask their healthcare provider or pharmacist for more information. Patients should call their doctor for medical advice about side effects of Tecentriq.

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.Tecentriq.com for the Full Tecentriq Prescribing Information for additional Important Safety Information.

About Genentech in cancer immunotherapy

Genentech has been developing medicines to redefine treatment in oncology for more than 35 years, and today, realizing the full potential of cancer immunotherapy is a major area of focus. With more than 20 immunotherapy molecules in development, Genentech is investigating the potential benefits of immunotherapy alone, and in combination with various chemotherapies, targeted therapies and other immunotherapies with the goal of providing each person with a treatment tailored to harness their own unique immune system.

In addition to Genentechs approved PD-L1 checkpoint inhibitor, the companys broad cancer immunotherapy pipeline includes other checkpoint inhibitors, individualized neoantigen therapies and T cell bispecific antibodies. For more information visit http://www.gene.com/cancer-immunotherapy.

About Genentech

Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20200617005876/en/

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Genentech's Tecentriq in Combination With Chemotherapy (including Abraxane) Meets Primary Endpoint of Improved Pathological Complete Response,...

Recommendation and review posted by Bethany Smith

Gemma Collins has revealed she hopes to be pregnant next year when she turns 40.

The reality TV star has been trying to prepare her body in order to conceive and has lost nearly three stone on the advice of doctors.

Gemma believes if she could become pregnant, she could send a positive message to women who start a family later in their lives.

I would love to have a child, she told The Sun.

It would be great for me and such a positive message for all the girls out there who dont want to rush their life or their life has taken different a direction, like me whos put their career first.

But in my forties Id love everybody to see The GC walking around with a pram.

Read more: Jessie J shares infertility struggles, but vows she will be a mum one day

The TOWIE star isnt worried about hitting the birthday milestone pointing out other stars who are enjoying successful careers into their forties and beyond, some of whom are yet to become parents.

Im going to be up there with them all Mariah Carey, Madonna, Kylie Minogue and Jennifer Aniston.

Kylies not married yet or got children. Jennifer hasnt got kids either.

Dont write us off yet. Were just beginning.

Read more:Kelly Brook shares two stone weight loss

When it comes to conceiving a child, Gemma, who refers to herself as The GC, has had regular consultations with her doctor about her prospects, having suffered a number of miscarriages in her thirties.

And though shes been told it is possible for her to become pregnant doctors have advised losing weight could help her achieve her parenting dream.

I can definitely have a child, he just told me it would be easierwhen Im not carrying as much weight, she told The Sun.

He gave me the confidence not to panic about it. He told me to lose a few stone and it will help me.

And the lockdown period has provided Gemma with an opportunity to take stock of where she was in life and make some positive changes for the future.

Things are a lot calmer now, she said. Im cooking my own meals at home, riding my bike in the countryside and enjoying long walks. I am established. My career has gone above and beyond.

Read more:Carer slimmed down by as much as Adele

An additional factor in Gemmas journey to motherhood is that she hasPolycystic ovary syndrome (PCOS), a condition that affects how a woman's ovaries work and can impact fertility.

Gemma was 28 when she was diagnosed with the condition after becoming alarmed by sudden weight gain.

She says: I was always very slim. But I really started piling on the weight and Ill never forget it.

I said to my mum, Have you shrunk my clothes?. She said, I hate to break this to you,but youre putting on weight.

Figures frompcos-uk.org.uksuggest that one in 10 women have PCOS, which roughly translates into 3.5 million women in the UK, and makes it the most common female hormone condition.

Symptoms can include irregular periods, weight gain and excess hair growth.

Read more: Size 20 nursery worker, who ate McDonald's five times a week, sheds four stone in three months

Some women with the condition can experience difficultygetting pregnant as a result of irregular ovulation or failure to ovulate.

Women who are overweight and trying to get pregnant will be advised to lose weight before trying fertility drugs or treatments, explains Mr Parijat Bhattacharjee, consultant gynaecologist at BMI The Clementine Churchill Hospital and BMI Syon Clinic in West London.

Losing weight might be enough to restart ovulation, and fertility drugs are also most effective on women with a healthy body mass index.

According to the NHS medications are also available to treat symptoms such as excessive hair growth, irregular periods and fertility problems.

If fertility medications are not effective, a simple surgical procedure called laparoscopic ovarian drilling (LOD) may be recommended.

This involves using heat or a laser to destroy the tissue in the ovaries that's producing androgens, such as testosterone.

For women who do get pregnant, being a healthy weight helps to reduce the risk of complications throughout the pregnancy, including gestational diabetes, high blood pressure and pre-eclampsia, Mr Bhattacharjee adds.

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Gemma Collins reveals her desires to have a baby in her forties, talks losing weight to try to get pregnant - Yahoo Sports

Recommendation and review posted by Bethany Smith

One of the dark-horse contenders in a race to the finish line with a new vaccine for Covid-19 has just wooed a senior AstraZeneca researcher to the fold as its new chief medical officer.

Novavax reports that it has recruited Filip Dubovsky to the team after a 14-year stretch at MedImmune/AstraZeneca. While at the big AstraZeneca sub, Dubovsky had been area head for infectious diseases and vaccines. Earlier he had been scientific director for PATH, a malaria vaccine initiative.

Dubovskys arrival comes 1 day after Novavax announced that David Mott the ex-CEO at MedImmune recently retired from a top spot at New Enterprise Associates is joining the board.

Novavax also hired Silvia Taylor, as SVP, investor relations and corporate affairs.

Novavax jumped into the race with a seed grant from the Coalition for Epidemic Preparedness Innovations, which followed up with a grant of up to $384 million. And just yesterday, the company raised $200 million in an equity investment from RA Capital. But the biotech has been noticeably absent from the frontrunners cited by Operation Warp Speed so far in any case. John Carroll

It would come as no surprise that Stphane Bancel is bullish about Modernas Covid-19 vaccine candidate, which has garnered plenty of attention as the frontrunning project most steps of the way. But just how bullish may yet turn some heads.

In an interview with CNBC, Bancel went on the record giving it an 80% to 90% chance that mRNA-1273 can reduce the risk of disease by half, or efficacy of above 50% in technical speak.

At the public health level, a vaccine with 50% [efficacy] will slow down drastically infections, Bancel said, even if it doesnt protect everyone who gets exposed to SARS-CoV-2.

He was cautious not to commit to a probability around 90% efficacy, saying hed need more data to assess. Yet the optimism is still extraordinary: As CNBC noted, new vaccines entering human trials from 2000 to 2015 had about a 1-in-3 chance of getting approval.

Bancel cites several reasons why Moderna, a 10-year-old startup, was able to leapfrog storied biopharma players. The mRNA technology lends itself to rapid turnaround; its been tested against nine other pathogens; it had a trial run with partners at the NIH in MERS; and it boasts of its own manufacturing site near its headquarters in Boston.

Having touted somewhat controversially an antibody response from eight patients in the Phase I trial and more recently released animal data, Moderna has outlined a 30,000-person Phase III trial to begin in July. The goal is to have a vaccine ready to deploy by the end of the year a goal NIAID director Anthony Fauci has called aspirational, but its certainly doable. Amber Tong

The stock of one of Martin Shkrelis former biotechs has been soaring over the last month, from less than a $1 to more than $5 per share.

Humanigen, which for several weeks in 2015 was run by the infamous Pharma Bro, makes anti-inflammatories for use in, among other things, the hyperactive immune responses, called cytokine storms, that often afflict patients who receive CAR-T cancer treatments. That made their drug a natural fit for Covid-19 after doctors determined these storms were causing some of the worst symptoms in infected patients.

Still, the data on their drug, a GM-CSF inhibitor called lenzilumab, are still highly limited. In a non-controlled preprint posted on MedRxiv earlier this week, 12 patients with severe pneumonia and at least one co-morbidity associated with poor Covid-19 outcomes, were given the drug. Of those, 11 were discharged within 5 days, with no treatment-emergent adverse effects.

That particular round of data sent their stock from $4.08 to $5.45. The company plans to test their drug in larger trials.

Shkreli and an investor group bought a majority stake in the company, then known as KaloBios, in 2015. But when Shkreli was arrested for security fraud for his dealings at a different company, KaloBios fired him. It filed for bankruptcy soon after and re-emerged in 2016 as Humanigen.

On June 2, Venrock, Citadel, and Valiant invested $72 million into the company, spurring the initial resurgence in value and prepping the company for scaling the drug should it be approved.

CEO Cameron Durrant, in an interview with theWall Street Journal, called Shkrelis time at the company an unfortunate history that lasted roughly 3 weeks.

TheNew York Timesreported earlier this month that the Trump administration had whittled Operation Warp Speed from 14 to 5 different vaccine candidates, but HHS said yesterday that there would be 7 candidates that move beyond the initial list.

And for vulnerable Americans, any vaccine that comes out of the project will be free.

The number of candidates beyond the initial list, in line with early reporting fromBloomberg,give renewed hope for vaccine developers who were left off the initial reported list. That includes Novavax and Inovio, both of which are in Phase I, and Sanofi, a company long backed by HHS and which expects to put their vaccine into clinical testing by the end of the year.

The list of 7 will then be winnowed to a smaller, unspecified number of finalists. The 7 will receive funding and assistance for early trials, and the final few will receive aid for large-scale testing and manufacture. The first of those large trials are expected to come this summer: from Moderna, AstraZeneca and J&J, in that order. The work of scaling is also underway, most recently with federal contracts of $628 million for Emergent BioSolutions and a $204 million for Corning, who will make vials to store and distribute a vaccine.

Questions of price have been thorny so far for the top vaccine developers. Some, such as J&J and AstraZeneca, have said they will not profit on the vaccine. Moderna and Pfizer have said they will not charge exorbitantly.

Administration officials pledged to make the vaccine available to those who cant afford it or are vulnerable on a conference call yesterday, according to several media reports. The officials also said that they cant guarantee a vaccine will be available by January, the widely reported aim of the initiative. Jason Mast

Two days after the German government poured 300 million into the mRNA biotech CureVac, the company announced it will put their vaccine into human trials.

Although straggling some of the other major players, the date of the announcement is in line with the timeline CureVac laid out over the winter. Still, it comes on the heels of three tumultuous months for a company that previously reached unicorn status while largely avoiding controversial headlines.

Arguably the first biotech built around mRNA, CureVac was one of the first companies to publicly begin work on a Covid-19 vaccine after the outbreak emerged, and they were quickly backed by the Center for Epidemic Preparedness Innovations.

Then a flurry of headlines hit over a single week in March. First CEO Daniel Menichella was replaced by founding CEO Ingmar Hoerr. The company cited the need for leadership with a scientific background during a crisis, but the news of a CEO shift in the middle of an unprecedented vaccine race prompted widespeculation.

Then later that week,Reutersand a prominent German paper reported that the Trump administration had tried to lure CureVac to the US to secure access to their Covid-19 vaccine, alarming German officials and beginning what has since been months of international tussling over vaccine access. (CureVac denied the reports, but theNew York Timessubsequently reported similarly). The EU subsequently made80 million available to CureVac to shore up manufacturing on the continent on the same day Hoerr announced that, after a week-long return, he was stepping down for medical reasons and CCO Franz-Werner Haas would step in as acting CEO.

The concerns over access to CureVacs vaccine havent dissipated. TheFinancial Timesreported that the 300 million German government investment was intended to ward off a planned IPO.FTcited a document from the German Finance Ministry: Theintended acquisition of a federal shareholding in CureVac is intended to ensure that the company is not taken over by a foreign investor and that it does not leave the country It is feared that in case of takeover and migration abroad, a vaccine against Covid-19 developed by CureVac in the future will not be made available to Germany and Europe.

Unlike Moderna or the Pfizer-partnered vaccine developer BioNTech, CureVac uses a form of mRNA vaccine that triggers an innate immune response, which theyve long touted as allowing them to give much smaller doses and thus produce far more vaccines. (Moderna considered the technology early in its history and decided against it.) Their first trial, set to take place in Belgium and Germany, will test between 2 and 8 micrograms in 168 patients. Moderna, by contrast, tested between 10 and 200 micrograms. Jason Mast

For a look at all Endpoints News coronavirus stories, check out our special news channel.

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Covid-19 roundup: Novavax recruits AstraZeneca vet as its new CMO right after David Mott jumps on the board; Operation Warp Speed will cut to 7...

Recommendation and review posted by Bethany Smith

Sonya Lynchs youngest child was central to her discovery that she had breast cancer.

My gorgeous bubbly little man he was nearly three at the time jumped on top of me in the bed. This led to me feeling discomfort in my breast that I found hard to ignore. Four weeks later that breast was removed.

To this day, the family based in Douglas, Cork call the little boy, now aged eight, their hero. We joke that he might grow up to be an oncologist and jump on peoples bellies to diagnose them, says the 45-year-old mum of three.

But jokes aside, Sonya says cancer has been the biggest crisis theyve had to deal with as a family. When it hit back in May 2014, she had never felt healthier. I looked and felt well.

Finding out she had hormone-positive breast cancer sent her into shock but the former paediatric nurse also knew it would be relatively easy to treat. She quickly underwent a mastectomy of her left breast, followed by chemotherapy. In early 2015 she had breast reconstruction and then reduction of her right breast, after which she went on cancer-prevention drug Tamoxifen.

Sonya Lynch at home in Douglas, Cork.Picture: Eddie O'Hare

I stayed on Tamoxifen until 2018 when nodules appeared on my lung, which meant more aggressive hormone therapy was needed. This basically shut down my ovaries to eliminate the oestrogen that my cancer feeds on. I need regular scans to monitor how effective this is and I had to have CyberKnife radiotherapy [non-invasive alternative to conventional surgery] recently to complement it.

Sonya says she found her secondary diagnosis very isolating and cripplingly fearful but is grateful for meeting many kind people who recognise the need for supporting women to help themselves. My medical care has been excellent, but its difficult for oncologists to cover all aspects of our care. Clinic times are mostly taken up with discussing crucial planning of treatments, with scan results and so on. Cancer is only half the story. Theres a huge need for psychological support.

She points to social confidence and self-worth taking a battering when women lose their hair due to chemo. She recalls after shed lost hers, her husband introducing her to somebody hed gone to school with. I felt like a 70-year-old woman. I wanted to scream: this is not me! It was as if Id been made to wear the most horrible embarrassing jacket that wasnt me. I felt I had to explain to everyone, even strangers, that this wasnt my taste.

Sonya and Don Lynch with their children from left, Isaac, Isabele and Alex at home in Douglas, Cork Picture: Eddie O'Hare

And, while she says it sounds like vanity, it really isnt. Its psychological. You cant hide away you have to face people. As a mother, you have to go to the school gate, for example. Shes also very conscious of how tough a cancer diagnosis is on loved ones, especially on ones partner.

I knew what I was feeling and what my limits were. I can vividly remember some really low points, but something would pick me up again. My husbands a quiet man. He didnt tell anyone initially. But when I lost my hair, well you cant deny that. Thats when it hit him, when my hair came out. And while a husband might be able to take a day off work when his wifes going through surgery, he most likely wont be able to take a day off to go for counselling for himself.

Adding that shes blessed with an amazing husband and that cancer has brought them closer, she can completely see how such a diagnosis can put a couples relationship under stress. She knows that maintaining confidence and intimacy with your partner is challenging and she recalls joking with a friend whod undergone surgery for varicose veins and who was going on a weekend trip with her partner.

When I told her to enjoy her romantic weekend, she said: What romantic weekend? With all this stitching? And I said: Well try it with no hair and one boob.

Having gone through treatment that induced menopause and all of the consequent side effects, Sonya says: Luckily, I have a very understanding husband. He loves me for who I am and we still manage to be very close and intimate.

Women with cancer are daughters, sisters, mothers, partners, friends, employees and employers, and the knock-on effects of cancer hit all, says Sonya. Theres often a lot of support when a womans undergoing treatment, at the time when she needs to step away from her usual duties. But what about afterwards?

Not long after, we need and want to return to our roles [jobs]. But were not the same. Recognising that vulnerability can bring surprising benefits, as opposed to struggling with trying to regain the life we once had, she says, adding that she returned to work as a paediatric nurse but found shift work too hard physically.

So I changed to a cancer information-giving job with the Marie Keating Foundation.

Sonya and Don Lynch at home in Douglas, Cork Picture: Eddie O'Hare

Sonya has been proactive about helping herself cope with cancer, its treatment and the side-effects. She has gained vast information by attending conferences, as well as remedies to counter side-effects. And she has found mindfulness techniques at Cork ARC House invaluable.

She has also been involved, in a consulting role alongside other patients, with the Irish Cancer Society in helping set up The Womens Health Initiative, a pilot scheme that will see clinics established in Cork and Dublin, aimed at improving the health/wellbeing of female cancer survivors.

The initiative will see clinics established in Cork and Dublin aimed at improving the health and wellbeing of female cancer survivors.

The clinics were designed in close consultation with women like Sonya Lynch whove suffered profound side effects after treatment. The clinics in Cork and Dublin will run on a trial basis for two years. The clinics will involve initial groups of selected participants, and it is hoped that the pilot scheme will eventually lead to the roll-out of a national programme for cancer survivors.

The Womens Health Initiative is funded to the tune of 890,000. The Irish Cancer Society is the single largest funder. The Society is hugely reliant on public donations for funding and with Daffodil Day cancelled this year, the public is invited to donate online at http://www.cancer.ie

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'Cancer is only half the story. Theres a huge need for psychological support' - Irish Examiner

Recommendation and review posted by Bethany Smith

DUBLIN--(BUSINESS WIRE)--The "Global Regenerative Medicine Market: Size & Forecast with Impact Analysis of COVID-19 (2020-2024)" report has been added to ResearchAndMarkets.com's offering.

This report provides an in-depth analysis of the global regenerative medicine market with description of market sizing and growth. The analysis includes market by value, by product, by material and by region. Furthermore, the report also provides detailed product analysis, material analysis and regional analysis.

Moreover, the report also assesses the key opportunities in the market and outlines the factors that are and would be driving the growth of the industry. Growth of the overall global regenerative medicine market has also been forecasted for the years 2020-2024, taking into consideration the previous growth patterns, the growth drivers and the current and future trends.

Regenerative medicines emphasise on the regeneration or replacement of tissues, cells or organs of the human body to cure the problem caused by disease or injury. The treatment fortifies the human cells to heal up or transplant stem cells into the body to regenerate lost tissues or organs or to recover impaired functionality. There are three types of stem cells that can be used in regenerative medicine: somatic stem cells, embryonic stem cells (ES cells) and induced pluripotent stem cells (iPS cells).

The regenerative medicine also has the capability to treat chronic diseases and conditions, including Alzheimer's, diabetes, Parkinson's, heart disease, osteoporosis, renal failure, spinal cord injuries, etc. Regenerative medicines can be bifurcated into different product type i.e., cell therapy, tissue engineering, gene therapy and small molecules and biologics. In addition, on the basis of material regenerative medicine can be segmented into biologically derived material, synthetic material, genetically engineered materials and pharmaceuticals.

The global regenerative medicine market has surged at a progressive rate over the years and the market is further anticipated to augment during the forecasted years 2020 to 2024. The market would propel owing to numerous growth drivers like growth in geriatric population, rising global healthcare expenditure, increasing diabetic population, escalating number of cancer patients, rising prevalence of cardiovascular disease and surging obese population.

Though, the market faces some challenges which are hindering the growth of the market. Some of the major challenges faced by the industry are: legal obligation and high cost of treatment. Whereas, the market growth would be further supported by various market trends like three dimensional bioprinting , artificial intelligence to advance regenerative medicine, etc.

Market Dynamics

Growth Drivers

Challenges

Market Trends

Companies Profiled

For more information about this report visit https://www.researchandmarkets.com/r/ufteqn

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Global Regenerative Medicine Market (2020 to 2024) - Size & Forecast with Impact Analysis of COVID-19 - ResearchAndMarkets.com - Business Wire

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Researchers say that very few people with autism are undergoing the genetic testing they should. (Dreamstime/TNS)

It is widely recommended that individuals with autism receive a battery of genetic tests, but new research finds strikingly few people on the spectrum partaking.

Just 3 percent of those with autism have received both chromosomal microarray and fragile X testing, according to findings from a study published recently in the journal JAMA Psychiatry.

The American Academy of Pediatrics, the American College of Medical Genetics and the American Academy of Child and Adolescent Psychiatry all recommend both assessments in order to determine more precisely what might underlie an individuals symptoms and point to treatment options, the researchers said.

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The study looked at medical records and self-reported information from 1,280 people with autism ranging in age from 1 to 68 between 2013 and 2019. More than 16 percent of the participants said they had received some variety of genetic testing, with 13 percent having undergone fragile X testing and 4.5 percent receiving chromosomal microarray testing. But, the researchers found that only a small number of people were taking both of the recommended tests.

I had the impression that the frequency of recommended genetic testing was not going to be very high based on the patients I encounter clinically, but 3 percent is actually lower than I thought it would be, said Daniel Moreno De Luca, an assistant professor of psychiatry and human behavior at Brown University who worked on the paper.

The study found that genetic testing is more common for those diagnosed in recent years. Among individuals diagnosed with autism between 2010 and 2014, nearly 10 percent said they had received chromosomal microarray testing, which is a more modern offering. But, adults with autism were unlikely to have had any genetic testing.

Researchers behind the study said their findings highlight a disconnect between research and professional recommendations and whats happening in clinical practice.

This paper is really about how you implement clinical genetic tests in the clinical diagnostic setting, said Eric Morrow, an associate professor of biology at Brown and an author of the study. There is rapid progress from research, and then theres the doctor and health systems that need to translate that to clinical practice.

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Despite Recommendations, Genetic Testing Rare Among Those With Autism - Disability Scoop

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Progenity, a molecular diagnostics testing lab, has amended its initial public offering filing and now aims to raise as much as $122.6 million through the sale of more than 7 million shares of its common stock.

The Ann Arbor, Michigan-based firm offers noninvasive prenatal tests for monogenic disease and chromosomal aneuploidies. It also carries a test for genetic diseases that parents can pass to their children.

Progenity initially filed in late May to go public, said it expects to float its shares on the Nasdaq at between $14 and $16 per share under the ticker symbol PROG. The underwriters of the planned offering Piper Sandler, Wells Fargo Securities, Robert W. Baird, Raymond James, and BTIG will also be granted a 30-day option to purchase an additional 1,000,000 shares at the IPO price.

Progenity is also redeveloping its proteomics-based preeclampsia rule-out test, and a platform for gastrointestinal (GI) disorders that uses a localizable, ingestible capsule to obtain a GI tract sample for diagnostic analysis or to deliver a therapeutic payload.

The molecular diagnostics testing lab said it expects to net approximately $103.0 million from the IPO, assuming a $15 per share offering price and full exercise of the underwriters' option. Progenity said it will use about $60 million to $65 million to support its operations, $9 million to $10 million to invest in its molecular testing R&D programs, and around $13 million to $15 million for its GI disorder platform.

The company also owes about $33 million to settle allegations of misconduct by three major insurance companies, it noted in the SEC filing.

Progenity recently agreed to pay millions to insurers Cigna, Aetna, UnitedHealthCare under settlement agreements related to allegations over undisclosed past business practices. Specifically, Progenity would pay Cigna $12 million on behalf of Avero, of which $2.5 million remains outstanding; Aetna $15 million, of which $7.5 million remains unpaid; and United HealthCare $30 million, with $23 million remaining to be paid.

Progenity also recently agreed to pay $49 million over a five-year period to resolve criminal and civil charges filed by the U.S. Department of Justice and the State of New York over discontinued billing practices for its NIPT and microdeletion tests, as well as alleged kickbacks or inducements made to physicians and patients. In the SEC filing, however, Progenity noted it had accrued $49 million as of March 31 to cover the potential settlement.

Natera on Wednesday sued Progenity, alleging that the firm's noninvasive prenatal test infringes six of its patents. The San Carlos, Cali-based genetic testing firm is seeking injunctive relief, monetary damages, court expenses, and a jury trial.

As of March 31, Progenity had $11.6 million in cash and cash equivalents.

This story first appeared in our sister publication, Genomeweb.

Original post:
Progenity eyes $122.6M in amended IPO - ModernHealthcare.com

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According to the World Health Organisation, breast cancer is the most frequently occurring cancer in women, affecting more than 21 lakh women every year. Breast cancer and ovarian cancer is determined by mutations in a prominent gene present in the body known as the Breast Cancer Gene (BRCA). The BRCA genes are not only present in women but men too.

Moreover, previous studies have shown that mutations (change in the structure) in the BRCA genes in men can increase the risk of breast cancer, prostate cancer, and other cancers. Recently, the Food and Drug Administration (FDA) of the US, approved two new drugs, rucaparib and olaparib, specifically for men with BRCA-positive prostate cancer that has stopped responding to other treatment.

Representational image. Pixabay

What is BRCA?

Each person has a DNA which forms the human body and helps it in functioning. Genes are a part of that DNA which gives each individual different traits. For instance, if a person has the genes for blue eyes, they will have blue coloured eyes. Similarly, BRCA is a type of gene which stands for Breast Cancer. There are two types of BRCA genes: BRCA1 and BRCA2. These genes produce tumour suppressor proteins which then help in repairing the damaged DNA.

Whenever there is an alteration (mutation) in any of these genes, there is either an absence of the protein formation or formation of faulty proteins. These faulty proteins are incapable of repairing the DNA damage, thus increasing the risk of cancer.

What all cancers have been linked to mutations in BRCA?

Mutations in BRCA1 and BRCA2 can increase the risk of several cancers in both men and women. In women, the mutation of BRCA can lead to the cancer of the breast, ovaries, fallopian tube and peritoneum. In men, BRCA mutations can increase the risk of breast cancer and prostate cancer. Harmful BRCA1 or BRCA2 mutations in both men and women can increase the risk of pancreatic cancer.

Can BRCA mutation run in family?

BRCA mutation can lead to cancer and cancers can run in the family. If you have a family member with a history of ovarian cancer, fallopian tube cancer, breast cancer, male breast cancer, prostate cancer, pancreatic cancer or even melanoma, then it is possible that a BRCA mutation is running in your family.

Are there any tests that can help detect mutations in BRCA1 and BRCA2?

Yes, there are several tests available that can help in determining harmful BRCA1 or BRCA2 gene mutation that has already been recognised in another family member. Multigene panel testing is one such test which uses next-generation sequencing to find out harmful mutations in many genes that are linked with an increased risk of breast and ovarian cancer along with BRCA1 and BRCA2.

For this test, the doctor studies the DNA derived from the blood or saliva samples.

If you have a family history of cancer, you can reach out to a doctor for genetic counselling and theyll be able to guide you further and help you decide if you need genetic testing.

For more information, read our article on Breast Cancer.

Health articles in Firstpost are written by myUpchar.com, Indias first and biggest resource for verified medical information. At myUpchar, researchers and journalists work with doctors to bring you information on all things health.

Updated Date: Jun 16, 2020 22:42:16 IST

Tags : BRCA, BRCA Genes, BRCA Genes In Men, brca1, brca2, Breast Cancer Gene, Breast Cancer Genes, DNA, FDA, Genetic Mutation, Genetic Testing, Health, Mutation, Myupchar, NewsTracker, Olaparib, Reuters, Rucaparib, WHO, World Health Organisation

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Breast Cancer genes found in both men and women; here's all you need to know about BRCA and genetic testing - Firstpost

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It has been another busy week for FDA as the agency made moves to broaden COVID-19 testing including those who are not showing any symptoms of having the virus while also cracking down on fraudulent testsand revoking an antibody test that was previously authorized.

The agency posted template updatesregarding the validation of molecular diagnostic tests for developers that intend their assay to be used for pooling patient samples or for screening asymptomatic individuals not suspected of having COVID-19. The agency also published a FAQswith information regarding tests for screening asymptomatic individuals.

FDA has authorized molecular diagnostic tests for anyone whose healthcare providersuspectsof having the virus that causes COVID-19, whether they are symptomatic, pre-symptomatic, or asymptomatic. It has always been the healthcare provider's discretion to test patients who don't exhibit any of the symptoms if, for example, the individual has been in contact with someone else who has tested positive for the virus. However, FDA says that is not the same as using COVID-19 diagnostic tests as a broad screening tool.

The agency's updated templates for test developers explains FDA's expectations for how a test can be validated for screening of asymptomatic individuals, in an effort to make it easier to get tests authorized for this use. The point is so that organizations can conduct screening as part of a broader strategy to ensure the safety of employees, patients, students, and others.

FDA said that in order to preserve testing resources, many developers are interested in performing their COVID-19 testing using a technique of "pooling" samples, which allows a lab to mix several samples together in a batch or pooled sample and then process the pooled sample with a diagnostic test. For example, four samples may be tested together, using only the resources needed for a single test. If the pooled sample is negative, it can be deduced that all patients were negative. If the pooled sample comes back positive, then each sample needs to be tested individually to find out which was positive.

Because samples are pooled together, ultimately fewer tests are run overall, meaning fewer testing supplies are used, and results can be returned to patients more quickly in most cases, FDA said. The agency warned, however, that because samples are diluted, there is a greater likelihood of false negative results, particularly if not properly validated. The agency said this method works well when there is a low prevalence of cases, meaning more negative results are expected. Testing asymptomatic individuals means testing a greater volume of patients, and a low prevalence may be more likely in an asymptomatic population, particularly if the population is at low risk for contracting COVID-19, FDA said developers may be interested in using pooling techniques in tests for asymptomatic screening.

FDA also slapped three companies with warning letters this week for marketingadulterated and misbranded COVID-19 antibody tests. Generally, antibody tests, also called serological tests, detect antibodies to SARS-CoV-2, which can help identify individuals who have developed an adaptive immune response to the virus, as part of either an active infection or a prior infection. These tests may be important in the fight against this pandemic, the agency noted, as they may provide information on disease prevalence and the frequency of asymptomatic infection. Todays warning letters are the first set of letters the agency has issued for marketing adulterated or misbranded COVID-19 test kits.

Warning letters were issued to:Medakit Ltd.of Sheung Wan, Hong Kong;Antibodiescheck.com and Yama Group; andDr. Jason Korkus, DDS and Sonrisa Family Dental d/b/a My COVID19 Clubof Chicago, Illinois.

Providing regulatory flexibility during this public health emergency never meant we would allow fraud, said Jeff Shuren, MD,director of FDAs Center for Devices and Radiological Health. When tests are marketed inappropriately, with inaccurate or misleading claims such as the ability to perform the test completely at home, or that the test is authorized, cleared, or approved when it is not they put the health of Americans at risk. Such conduct will not be tolerated by the FDA, and we will continue to monitor tests marketed in the U.S., taking appropriate action as warranted.

Violations outlined in the warning letters include: offering test kits for sale in the United States directly to consumers for at-home use without marketing approval, clearance, or authorization from the FDA; misbranding products with labeling that falsely claims products are FDA approved; and labeling that bears the FDA logo.

FDA says consumers and healthcare professionals are encouraged to report suspected fraud to FDA's health fraud program,the Office of Criminal Investigations, or emailFDA-COVID-19-Fraudulent-Products@fda.hhs.gov.

Performance/accuracy concerns prompted FDA to revoke the emergency use authorization ofChembio Diagnostic System's antibody SARS-CoV-2 antibody test, which was among the first COVID-19 antibody tests authorized in the United States. FDA said it previously authorized the test based on information Chembio submitted at the time because the test's known and potential benefits outweighed its known and potential risks.

This week the agency said that as ithas learned more regarding the capability for performance of SARS-CoV-2 antibodytests during the pandemic, and what performance is necessary for users to make well-informed decisions, FDA has developed general performance expectations for these tests, and Chembio's test didn't make the cut.

Data submitted by Chembio as well as an independent evaluation of the Chembio test showed that itgenerates a higher than expected rate of false results and higher than that reflected in the authorized labeling for the device. The agency said that the risk to public health from the false test results makes EUA revocation appropriate.

Since the beginning of the COVID-19 public health emergency, the FDA has balanced the urgent need for access to diagnostic and antibody tests with providing a level of oversight that helps to ensure accurate tests are being deployed, Shuren said. By continuing to monitor authorized tests and emerging scientific evidence, we are able to make changes when appropriate including taking action when a tests benefits no longer outweigh its risks. Through these efforts, we are able to help assure that FDA-authorized tests meet the needs of the American public.

To date, FDA has authorized140testsunder emergency use authorizations, which include 118 moleculartests, 21 antibodytests, and oneantigen test.

The agency also continues to authorize more tests that are designed for at-home sample collection. Most recently, Fulgent Geneticsreceived emergency use authorization for a COVID-19 diagnostic test.Fulgent said it will be offering the testing service through Picture Genetics, the companys consumer-initiated genetic testing platform, beginning next week.

One molecular diagnostic company is cutting through the noise and reaching investors ears with a rapid COVID-19 test. Cue Health said last week it has raised a sizeable $100 million in a series C financing to help support the development and commercialization of its tests, which includes a molecular diagnostic for COVID-19. Speaking of which, Cue Health finished out the week on a high note with FDA authorizing therapid, portable, point-of-care molecular test designed to detectthe RNA of SARS-CoV-2. The test uses a nasal swab sample taken from the lower partof the nose and produces results in 25 minutes, Cue said.

Another significant recent development on the testing front is the addition of next-generation sequencing.FDA gave Illumina the greenlight to bring the first next-generation sequencingCOVID-19 diagnostic test to the U.S. market, which is expected to become a key weapon in the battle against the virus. The test not only expands the United States' testing capabilities, but genetic sequencing information is expected to help scientists monitor if and how the virus mutates, which will be crucial as they continue to learn and fight the virus.

Abbott emerged as an early leader for COVID-19 testing, especially after bringing its ID NOW COVID-19 rapid test to the U.S. market. In May, however, the company went on the defensive after several independent research teams questioned the accuracy of the point-of-care molecular diagnostic test. One study in particular, out of NYU Langone Health,suggested that Abbott's test produced false negative results for almost half of the positive samples in a study of 101 patients. That study was criticized however becausethe patient samples were not collected at the point of care like the test was designed for. Instead, the researchers transported the samples to the hospital's laboratory within one or two hours and then tested using both Abbott's ID NOW machine and Cepheid's Xpert Xpress test. Abbott argued that outcomes of its ID NOW test depend on a number of factors including conformity to the way the test was designed to be run.ID NOW is intended to be used near the patient with a direct swab test method,"

FDA said on May 14 it was investigating concerns about the test, but the agency has not announced any updates or action related to those concerns.

Recently, Abbott published an interim analysis of an ongoingmulti-site clinical studyin urgent care clinics that indicates its ID NOW COVID-19 rapidtestis showing strong agreement to lab-based molecular polymerase chain reaction (PCR) instruments. Abbott said the interim results are demonstrating ID NOW COVID-19test performance is 94.7% in positive agreement (sensitivity) and 98.6% negative agreement (specificity) when compared to two different lab-based PCR reference methods.

Data from this, as well as two otherAbbott-sponsored studies The Everett Clinic in Washington and an ongoingstudyof hospitalized and nursing home patients suggest ID NOW performs best in patientstested earlier post symptom onset, when they are most likely to go for care. In these studies, ID NOW was used as intended with variations in patient populations based on the number of days a patient wastested after first experiencing symptoms, Abbott said.

Read more here:
FDA Looks to Bring COVID-19 Testing to More Americans - Medical Device and Diagnostics Industry

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Tempus, a Chicago-based technology company that offers genetic testing and aggregates clinical information, initially focused on cancer patients. But with the coronavirus pandemic spreading across the world, it's joining the fight against Covid-19.

Tempus was founded in 2015 by its CEO, Eric Lefkofsky, who previously co-founded the e-commerce company Groupon in 2008. But while Tempus' mission may seem far removed from that of an online discount marketplace, Lefkofsky had personal reasons for branching out.

"My wife was diagnosed with breast cancer about five years ago, and I was amazed how little data was actually used as a part of her therapy, largely because our system makes it hard for doctors to access data when making real-time clinical decisions," he said. "It became clear to me that I needed to try and tackle this problem, and I founded Tempus soon afterwards."

Tempus, which ranked No. 6 on the 2020 CNBC Disruptor 50 list, has three primary lines of business. It offers genomic tests that physicians can order, its most popular being a test that looks for over 600 genes associated with cancer. (It does not offer any direct-to-consumer genetic testing, like a 23andMe.)

After Groupon co-founder Eric Lefkofsky's wife was diagnosed with breast cancer, he discovered how hard the U.S. health system makes it for doctors to access data in clinical decision-making. That led him to found disease-agnostic AI start-up Tempus, which is now mining patient data for a potential Covid-19 medicine.

Tempus

It also partners with academic medical centers and community health-care systems to organize and aggregate clinical data, primarily data held in electronic health records. The clinical data is de-identified to protect patient privacy, then typically used in research projects to help understand patterns. Tempus claims to have one of the largest molecular and clinical data libraries.

There is crossover between these two businesses, as data from genomic tests that run in its Chicago and Atlanta labs can be de-identified and added to the molecular and clinical data library.

Finally, it curates and sells de-identified data to pharmaceutical companies working on drug discovery.

Tempus is a covered entity under the Health Insurance Portability and Accountability Act (HIPAA), so all of the datais scrubbed of patient name, date of birth, address and any other data point that could identify an individual.

Early on, Lefkofsky felt that the Tempus platform should apply to a broad cross-section of patient data. For this reason the Tempus platform was designed to be what the company calls "disease agnostic," which means it can be applied to patients suffering from many kinds of illnesses, including cancer, depression, diabetes, cardiovascular disease and Covid-19.

In April, Tempus began offering a polymerase chain reaction (PCR) test for Covid-19 from its Chicago and Atlanta laboratories. It currently expects to build its testing capacity to approximately 10,000 tests a day in the coming months. The test, offered through physicians, was rolled out parallel to the start of a research project to gather data on Covid-19 patients and look for patterns that can help physicians treating patients as well as drug-discovery efforts. Procedures may vary from patient to patient, but this is where Lefkofsky thinks the company's AI platform can do the most good.

"We are focused on collecting real-world evidence for patients that are Covid-19 positive to help doctors stratify patients based on risk and help triage patients to the optimal therapeutic path for them, based on their unique phenotypic characteristics," he said.

Dr. Scott Gottlieb, resident fellow at the American Enterprise Institute and special partner at New Enterprise Associates, sits on Tempus' board of directors. He joined after serving as commissioner of the Food and Drug Administration, where he spearheaded efforts to advance the use of artificial intelligence to create individualized patient care.

"I was impressed by the company's ability to rapidly scale its sequencing operations to support major academic institutions and community oncologists across the country and get data to patients and providers," he said. "They were focused not only on the back-end technologies to enable these opportunities, but equally important the front-end interfaces to make this information useful at the point of care."

Artificial intelligence could help us solve a number of serious public health problems and improve outcomes for patients with infectious diseases.

Scott Gottlieb

former FDA commissioner and Tempus board member

It also launched an initiative whose goal is to aggregate data for 50,000 patients who are Covid-19-positive. The hope is that this data will help reveal genetic characteristics that cause specific Covid-19 outcomes, as well as treatment practices for the illness.

Gottlieb added that Tempus is partnering with employers and health-care providers to support Covid-19 testing in states where restrictions are being relaxed, and employees are going back to work, so they'll know what to watch out for.

"We're going to have to be more aggressive in detecting and identifying respiratory viruses," he said. "To these ends, Tempus is also working on a next-generation sequencing panel for respiratory pathogens, including Covid-19, to diagnose patients and create a library for infectious disease research that could reduce the impact of future epidemics."

While Tempus' use of health data as a way to accelerate research shows promise, there are limitations.

Dr. Jose Morey, Chief Medical Innovation Officer for Liberty BioSecurity and advisor for MIT Solve and NASA iTech, said that one problem in relying on AI in the case of a new virus is that there isn't enough data at the moment.

"You have to have large data sets to be able to train, test, and validate," he said. "When you have something new and novel like this, they just don't exist. ... It will come eventually, but not yet."

More from Disruptor 50:Meet the 2020 CNBC Disruptor 50 companiesThe technology that will dominate daily life on the other side of coronavirusOpportunity Missed: Why there are no Black CEOs on this year's list

He added that the technology is also only as good as the data, and currently, there are systemic flaws in the way medical data is gathered and recorded. For example, he said that data in medical centers could be "dirty."

"This means that the data is not structured to be plugged into the math that is AI,'" he said. He added that health-care data is also frequently "siloed," or separated into unconnected compartments. For AI to do its job, it requires large amounts of interconnected data, which Morey said doesn't exist in the U.S. health-care system.

"Health-care entities, such as device manufacturers, electronic medical record vendors, and hospitals, are not incentivized to share data amongst each other," he said. "This is why there are so many AI companies doing incremental algorithm and application development."

In April, Tempus began offering a polymerase chain reaction (PCR) test from its Chicago and Atlanta laboratories. It expects to build its testing capacity to 10,000 tests a day in the coming months and hopes to aggregate data for 50,000 patients who are Covid-19-positive.

Tempus

While this is a challenging moment for the U.S. health-care system, Tempus has been recognized by the medical community and investors as a company whose platform shows great promise.

The company has raised $620 million from investors such as Baillie Gifford, Franklin Resourcesand T. Rowe Price,and is valued at $5 billion. It has also entered into a partnership with CVS Health, which allows oncologists in the CVS Health/Aetna network to use the results of its genomic sequencing tests.

Covid-19 research, like cancer research, has yet to yield a cure. However, Gottlieb said that he sees AI tools as indispensable for cancer patients, infectious disease patients and others in the future.

"As we collect more data and apply AI tools to large datasets, we can direct care to patients at greatest risk," he said. "Artificial intelligence could help us solve a number of serious public health problems and improve outcomes for patients with infectious diseases."

Correction: Tempus has raised $620 million from investors at a valuation of $5 billion. An earlier version of this article misstated the fundraising amount.

Disclosure: Scott Gottlieb is a CNBC contributor.

Original post:
Tempus: Health start-up backed by Groupon co-founder joins the fight against Covid-19 - CNBC

Recommendation and review posted by Bethany Smith

Federal and state law already prevents health insurers from using DNA data to influence their coverage. But Florida lawmakers want to expand that privacy to life, disability and long-term care insurance.

With that bill (HB 1189) now on his desk, Gov. Ron DeSantiswill offer the final say on whether the Sunshine State will become the first state to bar those insurance companies from using genetic tests like 23andMe for coverage purposes. And because incoming House SpeakerChris Sprowls spearheaded the effort, the Governor isnt likely to take out his veto pen.

Sprowls said he discovered the issue in December 2017 when he was applying for life insurance. While he was on hold on the telephone waiting for assistance, he said he was struck by commercials from companies such as 23andMe and AncestryDNA encouraging people to buy genetic tests.

Insurers have noted that information gleaned from genetic testing, such as a persons medical predispositions, could be used to lower insurance premiums across the board. But while it hasnt happened yet, that would punish genetic losers who would see a premium hike, lawmakers said.

The Senate approved the bill 35-3 with Democratic Sen. Kevin Raderand Republican Sens.Jeff BrandesandJoe Grutersdissenting. The amended proposal, which outlined that insurers could use genetic information if it came from a medical diagnosis, passed the House unanimously.

Dr.Robert Gleeson, a medical consultant for the American Council of Life Insurers, hasopposed the bill in past years.

Sen.Kelli Stargel led the Senate effort.

While countless Floridians have used DNA testing kits to learn more about their background or identify potential health risks, they didnt sign up in order for insurers to access this personal information and then base their policies on it, Stargel said in a prepared statement at the bills passage. We are elected to protect Floridians, and this good public policy protects them from insurers invading their private personal DNA data and using it against them.

DeSantis has until June 30 to veto the bill before it goes into effect July 1.

More here:
Gov. DeSantis to decide whether to expand DNA protections from insurers - Florida Politics

Recommendation and review posted by Bethany Smith

Using the mostcomprehensive genomic test availablerapid Whole Genome Sequencing (rWGS)the program called Project Baby Bear analyzed the genetic code of 178 infants to provide doctors and families with vital diagnostic information that empowered them tomake life-altering medical decisions resulting in shorter hospital stays, fewer invasive procedures and targeted personalized care.

"Among high-risk infants with rare, genetically determined diseases, time-to-treatment is crucial," said Stephen Kingsmore, MD, DSc, President and CEO of Rady Children's Institute for Genome Medicine (RCIGM). "Project Baby Bear significantly shortened the time needed to accurately diagnose and optimally treat these critically ill children."

Project Baby Bear helpeddoctors identifythe exact cause of rare, genetic diseasesin an average of three days, instead of the four to six weeks standard genetic testing offers. This allowed physicians to deliver timely treatment tailored to the baby's specific condition.

Through the program, Rady Children's Institute for Genomic Medicine provided rapid Whole Genome Sequencing for 178 babies eligible for Medi-Cal, resulting in a diagnosis for 43% that explained the reason for the infant's admission to the hospital; 31% had changes in their medical care as a result of rWGS.

In addition, substantial reductions in healthcare spending$2.5 millionaccrued largely because rWGS permitted doctors to discharge babies sooner (513 fewer hospital days) and reduce the number of procedures that may have been performed in the absence of a precise diagnosis. Avoided procedures included 11 major surgeries and 16 fewer diagnostic tests including open muscle, liver and other biopsies that are performed under general anesthesia.

"The economic data from Project Baby Bear showed that in addition to life-changing health benefits there are cost savings in getting a quick diagnosis from a single comprehensive test," said David Dimmock, MD, RCIGM Senior Medical Director. "Doctors were able to avoid additional testing, ineffective treatments and lengthy hospitalizations that would have resulted in greater pain and medical spending."

Project Baby Bear was funded by the State of California as a $2-million Medi-Cal pilot aimed at examining the benefits of using rWGS to help improve outcomes for infants hospitalized in intensive care with undiagnosed illness and whether the use of this technology would be cost effective.

Patient blood samples were sent to RCIGM for sequencing and interpretation from the California Children's Services accredited regional neonatal and pediatric intensive care units at the following participating hospitals:

The program was championed by Assemblymember Todd Gloria (San Diego) in partnership with the California Legislative Rare Disease Caucus led by Assemblymembers Brian Maienschein (San Diego) and Rob Bonta (Oakland). Strong support also came fromState Senate President Pro Tem Toni Atkins (San Diego); and Assemblymembers Joaquin Arambula, MD (Fresno); and Marie Waldron (San Diego).

Until the initiation of Project Baby Bear, Whole Genome Sequencing had not been covered by private insurance nor public health programs and was available only through clinical trials paid for by research grants or philanthropic donations.

"Project Baby Bear has shown that California is once again leading the way in improving the lives of children and families faced with unexplained rare diseases," said Patrick Frias, President and CEO of Rady Children's Hospital-San Diego. "Based on the results of this demonstration program, California is now in a position to be the first state to make this life-changing diagnostic solution available to every child who needs it."

Encouraged by the early success of Project Baby Bear, the State of Florida and State of Michigan have since initiated their own publicly-funded rWGS demonstration projects. In addition, San Diego Congressman Scott Peters introduced "Ending the Diagnostic Odyssey Act of 2019" that would provide rapid Whole Genome Sequencing to diagnose children with critical unexplained conditions. That bill, HR 4144, as well as is a counterpart bill in the U.S. Senate, are now pending.

Project Baby Bear Final State Report https://radygenomics.org/wp-content/uploads/2020/06/PBB-Final-Report_06.16.20.pdf

About Rady Children's Institute for Genomic Medicine: The Institute is leading the way in advancing precision healthcare for infants and children through genomic and systems medicine research. Discoveries at the Institute are enabling rapid diagnosis and targeted treatment of critically ill newborns and pediatric patients at Rady Children's Hospital-San Diego and collaborating hospitals. The vision is to expand delivery of this life-saving technology to enable the practice of precision pediatric medicine at children's hospitals across California, the nation and the world. RCIGM is a subsidiary of Rady Children's Hospital and Health Center. Learn more at http://www.RadyGenomics.org. Follow us on Twitterand LinkedIn.

About Rady Children's Hospital-San Diego: Rady Children's Hospital-San Diegois a 505-bed pediatric care facility providing the largest source of comprehensive pediatric medical services in San Diego, southern Riverside and Imperial counties. Rady Children's is the only hospital in the San Diego area dedicated exclusively to pediatric healthcare and is the region's only designated pediatric trauma center. In June 2020, U.S. News & World Report ranked Rady Children's among the best children's hospitals in the nation in all ten pediatric specialties the magazine surveyed. Rady Children's is a nonprofit organization that relies on donations to support its mission. For more information, visit http://www.rchsd.org and find us onFacebook,TwitterandVimeo.

Media Contact: Grace Sevilla Office: 858-966-1710 Cell: 619-855-5135 [emailprotected]

SOURCE The Rady Childrens Institute for Genomic Medicine (RCIGM)

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Rady Children's Shows Genomic Sequencing for Infants in Intensive Care Yields Life-Changing Benefits and Medical Cost Savings - PRNewswire

Recommendation and review posted by Bethany Smith

Global Breast Cancer Predictive Genetic Testing Market OverviewGlobal Breast Cancer Predictive Genetic Testing Market presents insights on the current and future industry trends, enabling the readers to identify the products and services, hence driving the revenue growth and profitability. The research report provides a detailed analysis of all the major factors impacting the market on a global and regional scale, including drivers, constraints, threats, challenges, opportunities, and industry-specific trends. Further, the report cites global certainties and endorsements along with downstream and upstream analysis of leading players.

The novel COVID-19 pandemic has put the world on a standstill, affecting major operations, leading to an industrial catastrophe. This report presented by Garner Insights contains a thorough analysis of the pre and post pandemic market scenarios. This report covers all the recent development and changes recorded during the COVID-19 outbreak.

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This Breast Cancer Predictive Genetic Testing market report aims to provide all the participants and the vendors will all the details about growth factors, shortcomings, threats, and the profitable opportunities that the market will present in the near future. The report also features the revenue share, industry size, production volume, and consumption in order to gain insights about the politics to contest for gaining control of a large portion of the market share.

Top Key Players in the Breast Cancer Predictive Genetic Testing Market: Amgen,Celgene,MagForce AG,Nanotherapeutics,Spectrum Pharmaceuticals,Ablynx,AMAG,CytImmune,Delpor,Nanospectra,Merrimack,Tarveda,.

Competitive landscapeThe Breast Cancer Predictive Genetic Testing Industry is severely competitive and fragmented due to the existence of various established players taking part in different marketing strategies to increase their market share. The vendors operating in the market are profiled based on price, quality, brand, product differentiation, and product portfolio. The vendors are turning their focus increasingly on product customization through customer interaction.Breast Cancer Predictive Genetic Testing Market segment by Regions/Countries: United States, Europe, China, Japan, Southeast Asia, India, Central & South America.

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Major Types of Breast Cancer Predictive Genetic Testing covered are:High Penetrant Genes,Intermediate Penetrant Genes,Low Penetrant Genes,

Major end-user applications for Breast Cancer Predictive Genetic Testing market:Hospitals,Clinics,Other,

Points Covered in The Report:

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Impact of Covid-19 on Breast Cancer Predictive Genetic Testing Market is Expected to Grow at an active CAGR by Forecast to 2026 | Top Players Amgen,...

Recommendation and review posted by Bethany Smith

London, June 16, 2020 (GLOBE NEWSWIRE) -- The non-invasive prenatal testing market is expected to grow at a CAGR of 17.1% from 2019 to 2027 to reach $13.14 billion by 2027.

With the emergence of innovative diagnostic and screening techniques, several methods of genetic testing are gaining popularity. These include carrier testing, preimplantation genetic diagnosis / screening (PGD / PGS), non-invasive prenatal testing (NIPT), paternity testing, and newborn screening. Technological advancements in the healthcare industry such as wearable healthcare devices, sequencing technologies, regenerative medicine, and genomic technologies, supported by breakthroughs in the field of genome sequencing and molecular research have opened new and promising pathways to combat genetic diseases and reduce the overall global economic burden.

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Among the innumerable advancements witnessed by the industry, non-invasive prenatal testing stands as one of the most distinctive technologies in curbing the concerns related to genetic diseases. NIPT a novel genetic screening method based on the analysis of cell-free fetal deoxyribose nucleic acid (cff-DNA) in the maternal plasma is considered as a valuable test for pregnant women, which provides early diagnosis of genetic disorders in fetus.

Further, advancements in genome sequencing technologies have reduced the turnaround time and lowered complexities associated with diagnosis. NGS technology provides several avenues to develop non-invasive diagnostic procedures for an early and accurate detection of various genetic disorders. This is driving several companies to invest in research and development of NGS-based NIPT products and develop innovative solutions for the market. For instance, in January 2019, Yourgene Health plc (U.K.) launched the Sage 32 plex test which uses Thermo Fishers Ion Torrent sequencing technology to detect placental cff-DNA in a maternal blood sample. Similarly, in September 2018, Yourgene Health formerly known as Premaitha Health plc. (U.K.) partnered with Illumina Inc. (U.S.) to use the Illuminas sequencing technology for the NIPT test developed by Premaitha.

The growth in the overall NIPT market is majorly driven by factors like shifting trend towards childbirth at an advanced maternal age, increasing prevalence of chromosomal abnormalities, availability of reimbursement for NIPT, and development of advanced technologies for non-invasive parenteral testing. However, the high cost of the non-invasive prenatal screening techniques hinders the growth of this market.

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The global non-invasive prenatal testing market studied in this report is segmented on the basis of product & solutions type (kits / consumables, systems, software), method (ultrasound screening & cell free DNA screening), application (trisomies, microdeletions, & sex chromosomal abnormalities), end user (diagnostic laboratories, hospitals, and academic & research institutes), and geography

On the basis of product and solution type, the kits / consumables segment commanded the largest share of the overall non-invasive prenatal testing market in 2019. The major share of this segment is attributed to the increasing incidence of chromosomal abnormalities, rise in the number of tests and products for NIPT, and improvement in regulatory approvals for NIPT assays.

On the basis of method, cell free DNA screening commanded the largest share of the overall non-invasive prenatal testing market in 2019. Technological advancements, increasing initiatives by companies to develop new NIPT products, and growing awareness for prenatal testing among pregnant women are the major factors driving the growth of the cell free DNA screening method for non-invasive prenatal testing.

On the basis of application, trisomy detection commanded the largest share of the overall non-invasive prenatal testing market in 2019. Rising incidences of trisomy due to increasing maternal age, higher accuracy of NIPT methods in trisomy detection, and lower cost of NIPT to detect trisomy as compared to other invasive methods are the major factors driving the growth of the NIPT products and solutions market for trisomy detection application.

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On the basis of end user, diagnostic laboratories commanded the largest share of the overall non-invasive prenatal testing market in 2019. Availability of the well-equipped facility and trained/skilled technicians and significant investments by government agencies to improve healthcare infrastructure are some of the key factors attributed to large share of diagnostic laboratories in the non-invasive prenatal testing market.

Geographically, the global non-invasive prenatal testing market is segmented into five major regions, namely, North America, Europe, Asia-Pacific, Latin America, and the Middle East & Africa with a further analysis of major countries in each region. North America commanded the largest share of the global non-invasive prenatal testing market in 2019, followed by Europe and Asia-Pacific region. The major share of the North American region is mainly attributed to the high diagnostic and treatment rate of trisomy disorders in the region, high awareness for prenatal testing, and presence of laboratories offering NIPT services in the region.

Some of the key players operating in the global non-invasive prenatal testing market are Illumina, Inc. (U.S.), Agilent Technologies, Inc. (U.S.), Thermo Fisher Scientific Inc. (U.S.), GE Healthcare (U.S.), PerkinElmer Inc. (U.S.), Beijing Genomics Institute (BGI) (China), Eurofins LifeCodexx (Germany), Natera, Inc. (U.S.), Igenomix S.L (Spain), Laboratory Corporation of America Holdings (U.S.), F. Hoffmann-La Roche Ltd (Switzerland), and Yourgene Health plc (U.K.).

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Non-Invasive Prenatal Testing (NIPT) Market Worth $13.14 Billion by 2027, Growing at a CAGR of 17.1% from 2019- Global Opportunity Analysis and...

Recommendation and review posted by Bethany Smith

The global market for high-resolution melting analysis is gaining momentum on account of the advancements in molecular biology. High-resolution melting analysis involves the microscopic study of double-stranded DNA samples to successively detect polymorphisms, epigenetics, and mutations. The study involves the amplification of the region where the mutational analysis needs to be carried out and generation of multiple copies of that region in the sample tube. The applications of high-resolution melting analysis in molecular biology are expansive, which is expected to play to the advantage of the market. TMR Research throws light on several market forces that are expected to contribute to the growth of the market over the coming. Moreover, a multifaceted approach to understand the knit and grit of the market was followed during research and analysis.

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One of the most important applications of point high-resolution melting (HRM) analysis is the detection of point mutation. The conventional method of SNP typing is expensive and time-consuming which shifts the focus on HRM analysis. Testing of zygotes has also emerged as an important application of HRM analysis, which is propelling demand within the global market. Apart from the above-mentioned applications, intercalating dyes used for the transition of double-standard DNAs to single-stranded ones are another key area that is projected to contribute to the growth of the market.

Genetic testing centers have been specifically very successful in North America which has given an impetus to the market. On the other hand, prominence of academic Institutes and research centers in Europe has also contributed to the growth of the regional market.

Global High-resolution Melting Analysis Market: Overview

High resolution melting analysis is a powerful and strong methodology in molecular biology for the purpose of detecting epigenetic differences, polymorphisms, and mutations in double-stranded DNA samples. It was first discovered and developed by the Idaho Technology and University of Utah. High resolution melting analysis has several advantages over genotyping technologies such as cost effectiveness, it is powerful and fast as compared to genotyping technologies, and it is comparatively simple. Based on products and services, the global high-resolution melting analysis market can be segmented into software and services, consumables and reagents, and instruments. In terms of application, it can be segmented into epigenetics, pathogen identification, species identification, mutation scanning, and SNP genotyping.

The global market for high-resolution melting analysis is likely to have a fruitful future owing to ongoing research and developments in this field sponsored by several leading companies operating in this particular field. For instance, FDA in the U.S. approves many treatments which are made for addressing a specific genomic profile or genetic makeup of the tumor of the patient.

Global High-resolution Melting Analysis Market: Drivers and Restraints

The prime factors that are boosting the growth of the market comprise the growing prevalence of cardiovascular diseases, COPD, chronic diseases such as cancer, and other different infectious diseases. The prime benefits associated with high-resolution melting analysis are optimization of therapies, patient compliance, drug safety, cost savings on several treatments, and disease diagnosis. In return, these are also expected to propel the demand for DNA testing services. Moreover, rising awareness pertaining to the applications of high resolution melting analysis technologies for HLA typing, mutation discovery, and DNA mapping are additional aspects that are anticipated to propel the growth of the high-resolution melting analysis market during the forecast period. High resolution melting analysis is a technology employed for assessing melting curve plots of amplified gene. This particular technology is basically used for gene mutation scanning, microbial species identification, methylation profiling, and other different diagnostics based on PCR. Thus, mutation scanning and other applications are likely to gain prominence over time owing to rising prevalence of advancements in technology of molecular biology, genetic disorders, and growing awareness pertaining to SNP typing.

Global High-resolution Melting Analysis Market: Market Potential

Growing government budget provision for research and development in the field of pharmaceuticals, biotechnology, and applied life sciences is a crucial factor heightening the demand for numerous diagnostic techniques and tools. For instance, in 2015, the Obama led administration announced the introduction of the Precision Medicine Initiative with a huge investment of US$216 mn in the Presidents budget of 2016. This initiative is further expected to have positive impact on the growth of the high resolution melting analysis market.

Global High-resolution Melting Analysis Market: Regional Overview

Region-wise, the market can be segmented into North America, Asia Pacific, Europe, and the Rest of the World. North America is expected to perform extremely owing to factors such as robust adoption of advanced technology in healthcare, numerous genetic testing centers, strong biotech and pharmaceutical industry, prevalence many academic universities, and high prevalence of diseases. Asia Pacific has also been identified as one of the potential regions where the market can grow steadily owing to dynamics such as rising prevalence of chronic diseases such as HIV, COPD, and cancer, growing cases of genetic disorders, and rising private and public expenditure on genetic testing and molecular diagnostic.

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Global High-resolution Melting Analysis Market: Competitive Landscape

The top drawer companies operating in the market areThermo Fisher Scientific, Kapa Biosystems, Idaho Technology Corporation, and Roche Molecular Systems.

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High-resolution Melting Analysis Market Current Outlook Of Industry & Forecast 2017-2025 - Owned

Recommendation and review posted by Bethany Smith

Testosterone Gel Industry report provides a basic overview of the industry including definitions, classifications, applications and industry chain structure. The Testosterone Gel industry analysis is provided for the international markets including development trends, competitive landscape analysis, and key regions development status.

Global Testosterone Gel Industry 2020 Research report is spread across 126 pages and provides exclusive vital statistics, data, information, trends and competitive landscape details in this niche sector.

Inquire more or share questions if any before the purchase on this https://www.orianresearch.com/enquiry-before-buying/1571158

The key players covered in this study

AbbVie

Teva

Perrigo

Endo Pharmaceuticals

Acerus Pharmaceuticals

Lupin

Dr. Reddys Laboratories

Upsher-Smith Laboratories.

This report focuses on price, sales, revenue and growth rate of each type, as well as the types and each type price of key manufacturers, through interviewing key manufacturers. Second on basis of segments by manufacturers, this report focuses on the sales, price of each type, average price of Testosterone Gel, revenue and market share, for key manufacturers.

Development policies and plans are discussed as well as manufacturing processes and cost structures are also analyzed. This report also states import/export consumption, supply and demand Figures, cost, price, revenue and gross margins. Third by regions, this report focuses on the sales (consumption), production, import and export of Testosterone Gel.

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The Global Testosterone Gel Industry focus on Global major leading industry players, providing information such as company profiles, product picture and specification, capacity, production, price, cost, revenue and contact information. Upstream raw materials and equipment and downstream demand analysis are also carried out.

Market segment by Type, the product can be split into

0.01

0.0162.

Market segment by Application, split into

Primary hypogonadism

Hypogonadotropic hypogonadism

Late-onset hypogonadism.

Market segment by Regions/Countries, this report covers

North America

U.S.

Canada

Europe

Germany

France

U.K.

Italy

Russia

Asia-Pacific

China

Japan

South Korea

India

Australia

Taiwan

Indonesia

Thailand

Malaysia

Philippines

Vietnam

Latin America

Mexico

Brazil

Argentina

Middle East & Africa

Turkey

Saudi Arabia

U.A.E.

Finally by applications, this report focuses on consumption and growth rate of Testosterone Gel in major applications.

Major Points Covered in Table of Contents:

1. Testosterone Gel Market Overview

2. Market Competition by Manufacturers

3. Production Capacity by Region

4. Global Testosterone Gel Consumption by Regions

5. Production, Revenue, Price Trend by Type

6. Global Testosterone Gel Market Analysis by Application

7. Company Profiles and Key Figures in Testosterone Gel Business

8. Testosterone Gel Manufacturing Cost Analysis

9. Marketing Channel, Distributors and Customers

10. Market Dynamics

11. Production and Supply Forecast

12. Consumption and Demand Fprecast

13. Forecast by Type and by Application (2021-2026)

14. Reseach Finding and Conclusion

15. Methodology and Data Source.

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Testosterone Gel Market: 2020 Industry Trends, Size, Growth Predictions, Segmentation, Business Statistics, Top Key Players and 2026 Forecast Research...

Recommendation and review posted by Bethany Smith

Anabolic steroids additionally called androgenic steroids are derivatives of testosterone, significant for advancing and keeping up muscle development and creating auxiliary male sex qualities, for example, an extending voice and facial hair. They are anabolic and increment protein inside cells, particularly in skeletal muscles, Anabolic steroids utilized restoratively in ailments to animate muscle increment, set off male adolescence and treat constant squandering conditions, comprising of malignancy and AIDS.

Increment in geriatric populace drives the androgens and anabolic steroids commercial center, as more men are susceptible to hypogonadism. Also, ascend in weight issues in men propels the overall androgens and anabolic steroids market. The growing negative health status specifically within the developing countries is projected to fuel the growth of the marketplace during the forecast period. Besides, rise in government ventures for higher human services is attributed to the growth of the overall androgens and anabolic steroids market. Increment in occurrence of hypogonadism among men is anticipated to enlarge the worldwide androgens and anabolic steroids market all through the forecast span. Rise in impotence among men due to weight problems and tiredness is expected to enhance demand for androgens and anabolic steroids during forecast duration.

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Anabolic Steroids Market can be segmented on basis of compound derivatives, mode of administration, applications, Distribution channels and geography.

On basis of synthetic derivatives, Anabolic steroids market is segmented as:

On basis of Modes of administration, Anabolic steroids is segmented as:

On basis of Applications, anabolic steroids is segmented as:

On basis of Distribution channels, anabolic steroids market is segmented as:

Anabolic steroids include di-hydro-testosterone, testosterone, and other marketers. Anabolic steroids stimulate the improvement of male sex organs and male sexual characters including growth of beard and deepening of voice. Various varieties of tissues grow due to stimulation of anabolic steroids, specifically muscle and bone. Rise in red blood cells production is due to anabolic results. Androgens and anabolic steroids are used for the remedy of breast cancer in ladies, impotence, hypogonadism in men, and alternative therapy delayed puberty in adolescent boys. Anabolic steroids are also used for the treatment of numerous conditions with hormonal imbalance, weight loss, osteoporosis, and anemia. Anabolic steroids market can be segmented based on synthetic derivatives, mode of administration, application, end-user, and region.

In terms of mode of administration, the market can be categorized into oral, injection, topical, skin patches and inhaler. Based on application type, anabolic steroids market can be divided into Anabolic, Androgenic and others. Based on distribution channels anabolic steroids market can be classified into hospital pharmacies, retail pharmacies and online pharmacies. The hospital pharmacies segment dominated the market owing to elevated availability of medications and hospitals being the first point of contact for treatment.

Anabolic steroids market in North America held the biggest marketplace share due to expanded prevalence of breast cancer in women. According to many researches, breast cancers is one of the main cause of death in U.S. Europe held the second largest share in anabolic steroids market because of accelerated occurrence of hypogonadism in men and delayed puberty in adolescent boys. The Anabolic steroids market in Asia Pacific is expected to grow at a fast pace during the forecast period attributable to multiplied government initiatives to get rid of breast cancer. Anabolic steroids market in Middle East & Africa is predicted to be driven via improved occurrence of impotence, hypogonadism in men, and behind schedule puberty in adolescent boys. The market in Latin America is projected to witness robust increase at some point of the forecast length due to accelerated government tasks within the fitness care sector.

Valeant, Endo Pharmaceuticals Solutions Inc., Germiphene Corporation, Taro Pharmaceuticals, Inc., Antares Pharma, Inc, Actavis Pharma, Inc, Sandoz, Pfizer, Unimed Pharmaceuticals, Upsher-Smith and others

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Excerpt from:
Anabolic Steroids Market to Witness Heightened Revenue Growth in the Next Decade - Owned

Recommendation and review posted by Bethany Smith

This post deals with suicide and might be triggering for some readers.

Yesterday morning, I woke up to the usual 10-minute morning cuddle session with my girlfriend who seemed uber content to be on the receiving end of my stream of kisses. Of course, I complained about how Im not working from home anymore, I worried about a bunch of things I cant change, and then I dropped my girlfriends five and eight year old kids to school on my way to work.

A quick Instagram scroll sent me into a spiral of shock, worry, and grief.

Sara Hegazy, 30, was found dead in her apartment in Canada by suicide.

Image: Twitter.

If youre not an Arab, news about Sara wouldnt have been in your feed. But my algorithms work differently. So I already knew that Sara is an Egyptian LGBT+ activist who rose to prominence after raising the LGBT rainbow flag at a concert in Egypt in October 2017.

What I didnt know was that Sara was charged with promoting sexual deviancy and debauchery, and was jailed for three months following that October 2017 incident. I also had no idea that she then suffered horrific beatings and abuse at the hands of other inmates, while prison officials would violently assault and torture her with electrocutions.

I cant help but think, this couldve been me.

Despite being warned by some friends, I decided to take a look at some of the comments and reactions to the post about Sara.

Ill do the honour of translating some for you.

Hell and misery is awaiting her.

Its not okay to have any form of empathy towards her.

Dont you know how to hide your sexuality? Do you think its okay to be public about your queerness while youre living in a conservative society? Whats next to come? Maybe someday, someone will come along and tell me its alright to have sex with children and animals too. Would you then consider this some sort of freedom of expression?

This couldve been written about me.

Im in conflict while writing this. I want to tell you that the Arab world is full of the warmest people Ive ever had the experience of knowing, food to die for, and a rich culture and heritage to be proud of.

But I also have to tell you that Im ashamed of the ignorance that is infiltrating my community. Ashamed of the debilitating inflexibility in the mindset of so many in that community.

Read more:
'Sara Hegazy was jailed and tortured for a photo. It could have been me.' - Mamamia

Recommendation and review posted by Bethany Smith

Physicians Wish More Women Understood They Are Not To Blame

DUBLIN, June 17, 2020 /PRNewswire/ -- Sixty percent (60%) of women surveyed feel it's their fault they have cellulite and 57% feel judged for their cellulite,i according to new Harris Poll survey results released today by Endo Aesthetics LLC, an affiliate of Endo International plc (NASDAQ: ENDP). Conversely, 92% of physicians surveyed wish more women understood having cellulite is not their fault.Although celluliteii is common, many women are unsure about its root causes, lack knowledge about treatment options and feel a sense of blame and judgment for having cellulite.

The Harris Poll survey was conducted online among 2,006 U.S. women and captured feedback from those ages 18-59 who have cellulite, as well as 302 board certified dermatologists and plastic surgeons. Harris polled the women and physicians about their experience with cellulite and current treatment options.

Of aesthetic physicians surveyed, 93% said most women want to know how to improve their cellulite. Additionally, one-third of women surveyed (34%) feel that having information on what does and does not cause cellulite would make it easier to have conversations with their physician about this topic.

"It doesn't surprise me that 60% of women surveyed feel it's their fault they have cellulite," says Lisa Donofrio, MD, a New Orleans based board-certified dermatologist, past president and board member of the American Society for Dermatologic Surgery, and a fellow of the American Academy of Dermatology. "I've consulted with patients who are embarrassed and frustrated with having cellulite; however, I want them to know that they are not alone. In fact, 80% of women surveyed said they have cellulite and over three-quarters of them noted they spend time or effort focused on it. It's a very common issue that can stem from a variety of factors, including but not limited to hormones, genetics, skin structure and skin texture."

Cellulite can have a negative impact on how women perceive themselves. Nearly half of women surveyed (49%) say they are bothered "a great deal" or "a lot" by their cellulite. Women most commonly think about their cellulite at certain times, including when looking in the mirror (65%), at the beach or pool (54%) and during warmer weather (46%).iii

"The Harris Poll survey results reinforce that many women are looking for trusted information and resources from their healthcare professionals," says Robert Catlin, Vice President of Aesthetic Sales and Marketing at Endo. "We undertook this survey to understand how women feel about their cellulite and to help remove the blame and replace it with data and information."

Additional highlights from the Harris Poll survey include:iv

Scientists continue to explore treatments that target the root causes of cellulite in minimally invasive ways.iCurrently, surgical and invasive options get to the bands under the skin's surface that can cause cellulite.iiTheHarris Poll survey showed many of the women surveyed tried to improve their cellulite using various methods, including exercise (71%), diet (58%), topical treatments (36%), massages (25%) and in-office procedures (12%).By releasing the Harris Poll survey results, Endo Aesthetics is seeking to clear up the misinformation that exists around the etiology of cellulite,which may be one of the reasons 74% of women surveyed said that "no matter what I do, I will always have cellulite."v

Research MethodThis survey was conducted online within the U.S. by The Harris Poll between January 2, 2020 and January 26, 2020 on behalf of Endo Pharmaceuticals among two groups: 2,006 women, ages 18-59 who have cellulite; and 302 licensed U.S. healthcare professionals, including 151 dermatologists and 151 plastic surgeons.

Patient data were weighted by age, education, race/ethnicity, region, income, household size, marital status, and employment status to be representative of the broader population. Propensity score weighting was also used to adjust for respondents' propensity to be online. Dermatologist and plastic surgeon data were weighted by gender, years in practice, and region, and a post-weight was applied to the total data to reflect the proportions of dermatologists and plastic surgeons within the U.S. population.

About CelluliteCellulite is a localized alteration in the contour of the skin that has been reported in over 90 percent of post-pubertal females and affects women of all races and ethnicities.vi,vii The presence of cellulite is associated with changes in dermal thickness, and in the fat cells and connective tissue below the skin. A primary factor in the cause of the condition is the collagen containing septae which attach the skin to the underlying fascia layers. The septae tether the skin which, with additional contributing protrusions of subcutaneous fat, causes the surface dimpling characteristic of cellulite.viii,ixThese fibrous septae are oriented differently with varying thickness in females than in males, which helps our understanding of cellulite as a gender-related condition.xi Cellulite clinically presents on the buttocks, thighs, lower abdomen and arms.

It is known that cellulite is different from generalized obesity. In generalized obesity, adipocytes undergo hypertrophy and hyperplasia that is not limited to the pelvis, thighs, and abdomen.xIn areas of cellulite, characteristic large, metabolically stable adipocytes have physiologic and biochemical properties that differ from adipose tissue located elsewhere.An anatomical study in 2019 found that women have increased fat lobule height compared with men, which may also contribute to the mattress-like appearance seen as a result of the tension of the fibrous septae.xi Weight gain can make cellulite more noticeable, but it may be present even in thin subjects.

About The Harris PollThe Harris Poll is a global consulting and market research firm established in 1963 to help support decision making among leaders. Harris workswith clients in three primary areas: crafting brand strategy, building corporate reputation, and earning organic media through public relations research. To learn more, visitwww.theharrispoll.com.

About Endo Aesthetics LLCEndo Aesthetics is embarking on a mission devoted to pushing the boundaries of aesthetic artistry. Driven by world-class research and development, Endo Aesthetics is advancing solutions to address unmet needs beginning with an investigational treatment for cellulite. Headquartered in Malvern, PA, Endo Aesthetics is an affiliate of Endo International plc (NASDAQ: ENDP). Learn more at https://www.endoaesthetics.com.

About Endo International plcEndo International plc (NASDAQ: ENDP) is a highly-focused specialty branded and generics pharmaceutical company delivering quality medicines to patients in need through excellence in development, manufacturing and commercialization. Endo has global headquarters in Dublin, Ireland, and U.S. headquarters in Malvern, PA. Learn more at http://www.endo.com.

Forward Looking StatementsThis press release may contain certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and Canadian securities legislation, including, but not limited to, the statements by Dr. Donofrioand Mr. Catlin, and other statements regarding the purpose and results of the survey. Statements including words such as "believes," "expects," "anticipates," "intends," "estimates," "plan," "will," "may," "look forward," "intend," "guidance," "future" or similar expressions are forward-looking statements. Because these statements reflect Endo's current views, expectations and beliefs concerning future events, they involve risks and uncertainties. Although Endo believes that these forward-looking statements and information are based upon reasonable assumptions and expectations, readers should not place undue reliance on them, or any other forward-looking statements or information in this news release. Investors should note that many factors, as more fully described in the documents filed by Endo with the Securities and Exchange Commission ("SEC") and with securities regulators in Canada on the System for Electronic Document Analysis and Retrieval ("SEDAR"), including under the caption "Risk Factors" in Endo's Form 10-K, Form 10-Q and Form 8-K filings, and as otherwise enumerated herein or therein, could affect Endo's future results and could cause Endo's actual results to differ materially from those expressed in forward-looking statements contained in this communication. The forward-looking statements in this press release are qualified by these risk factors. Endo assumes no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise, except as may be required under applicable securities laws.

References:

iEndo Pharmaceuticals data on file 2020. Cellulite Survey: Women and HCP Survey Results, The Harris Poll online survey, 1/2/20 1/26/20 of2,006 U.S. women ages 18-59 who have cellulite and 302 U.S. licensed physicians aged 18+iiZerini I et al. Cellulite treatment: a comprehensive literature review. J Cosmet Dermatol. 2015 Sep 14(3):224-40 iiiEndo Pharmaceuticals data on file 2020. Cellulite Survey: Women and HCP Survey Results, The Harris Poll online survey, 1/2/20 1/26/20 of2,006 U.S. women ages 18-59 who have cellulite and 302 U.S. licensed physicians aged 18+ivEndo Pharmaceuticals data on file 2020. Cellulite Survey: Women and HCP Survey Results, The Harris Poll online survey, 1/2/20 1/26/20 of2,006 U.S. women ages 18-59 who have cellulite and 302 U.S. licensed physicians aged 18+v Endo Pharmaceuticals data on file 2020. Cellulite Survey: Women and HCP Survey Results, The Harris Poll online survey, 1/2/20 1/26/20 of2,006 U.S. women ages 18-59 who have cellulite and 302 U.S. licensed physicians aged 18+viHexsel, D., & Mazzuco, R. (2013). Cellulite. Update in Cosmetic Dermatology, p.2viiKhan MH et al. Treatment of cellulite: Part I. Pathophysiology. J Am Acad Dermatol. 2010 Mar;62(3):361-70. viiiQuerleux B et al. Anatomy and physiology of subcutaneous adipose tissue by in vivo MRI and spectroscopy: Relationship with sex and presence of cellulite, Skin Research and Technology; 8: 118-124. ixQuerleux B et al. Anatomy and physiology of subcutaneous adipose tissue by in vivo MRI and spectroscopy: Relationship with sex and presence of cellulite, Skin Research and Technology; 8: 118-124. xKhan MH, Victor F, Rao B, Sadick NS. Treatment of cellulite: Part I. Pathophysiology. J Am Acad Dermatol 2010;62(3):361-370xi Rudolph C, Hladik C, Hamade H, Frank K, et al. Structural gender-dimorphism and the biomechanics of the gluteal subcutaneous tissue - implications for the pathophysiology of cellulite. Plast Reconstr Surg 2019; 143: 1077-86.

Photo - https://mma.prnewswire.com/media/1191944/Endo_International_Harris_Poll_Survey_Infographic.jpg

http://www.endo.com

SOURCE Endo International plc

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New Harris Poll Survey Shows 60% of Women Surveyed Feel It's Their Fault They Have Cellulite - PR Newswire UK

Recommendation and review posted by Bethany Smith

This high-end research comprehension on the Global Cryonics Technology Market renders major impetus on detailed growth facets, in terms of product section, payment and transaction platforms, further incorporating service portfolio, applications, as well as a specific compilation on technological interventions that facilitate ideal growth potential of the market.

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This study covers following key players:PraxairCellulisCryologicsCryothermKrioRusVWRThermo Fisher ScientificCustom Biogenic SystemsOregon CryonicsAlcor Life Extension FoundationOsiris CryonicsSigma-AldrichSouthern Cryonics

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This illustrative research report on the Cryonics Technology market is an all-in-one, ready to use handbook of market dynamics that upon mindful inference lends valuable insights on market developments, growth trajectory, dominant trends as well as technological sophistication as well as segment expansion and competition spectrum that have a strong bearing on the growth probabilities of the Cryonics Technology market.

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Market segment by Type, the product can be split into Slow freezingVitrificationUltra-rapid

Market segment by Application, split into Animal husbandryFishery scienceMedical sciencePreservation of microbiology cultureConserving plant biodiversity

The report further unveils pertinent details about segment contribution in coining ample revenue flow, sustainability and long term growth in global Cryonics Technology market. A thorough knowledge base of market facets remains integral and indispensable to decode Cryonics Technology market prognosis. This recent research compilation on the Cryonics Technology market presents a deep analytical review and a concise presentation of ongoing market trends that collectively inculcate a strong influence on the growth trajectory of the aforementioned Cryonics Technology market.

The report sheds light on the particular segment that sets revenue maximization, rolling, thus incurring steady growth in revenues and contributing towards steady sustenance of the Cryonics Technology market. This well versedreport is thoughtfully crafted to arm report readers with convincing market insights on the mettle of all aforementioned factors that propel relentless growth despite significant bottlenecks in the Cryonics Technology market.

Some Major TOC Points:1 Report Overview2 Global Growth Trends3 Market Share by Key Players4 Breakdown Data by Type and ApplicationContinued

In addition to all of the above stated inputs, discussed at length in the report, the report sheds tangible light on dynamic segmentation based on which the market has been systematically split into prominent segments inclusive of type, end use technology, as well as region specific diversification of the Cryonics Technology market to encourage highly remunerative business discretion.

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Global Cryonics Technology Market Projected to Reach USD XX.XX billion by 2025- Praxair, Cellulis, Cryologics, Cryotherm, KrioRus, VWR, etc. - Cole of...

Recommendation and review posted by Bethany Smith

Trending Cryonics Technology Market 2020: COVID-19 Outbreak Impact Analysis

Chicago, United States The Cryonics Technology market report provides a detailed analysis of global market size, regional and country-level market size, segmentation market growth, market share, competitive Landscape, sales analysis, impact of domestic and global market players, value chain optimization, trade regulations, recent developments, opportunities analysis, strategic market growth analysis, product launches, area marketplace expanding, and technological innovations

The Cryonics Technology market report 5 Years Forecast [2020-2025] focuses on the COVID19 Outbreak Impact analysis of key points influencing the growth of the market. The intelligence report prepared contains details on the leading players of the Global Cryonics Technology Market, along with various depending aspects related and associated with the market. Profile the Top Key Players of Cryonics Technology, with sales, revenue and global market share of Cryonics Technology are analyzed emphatically by landscape contrast and speak to info. Upstream raw materials and instrumentation and downstream demand analysis is additionally administrated. The Cryonics Technology market business development trends and selling channels square measure analyzed. Cryonics Technology industry research report enriched on worldwide competition by topmost prime manufactures which providing information such as Company Profiles, Gross, Gross Margin, Capacity, Product Picture and Specification, Production, Price, Cost, Revenue and contact information.

>>>>>>This Report Covers Leading Companies Associated in Worldwide Cryonics Technology Market: PraxairCellulisCryologicsCryothermKrioRusVWRThermo Fisher ScientificCustom Biogenic SystemsOregon CryonicsAlcor Life Extension FoundationOsiris CryonicsSigma-AldrichSouthern Cryonics

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Key Issues Addressed by Cryonics Technology Market: The Cryonics Technology report is a compilation of first-hand information, qualitative and quantitative assessment by industry analysts, inputs from industry experts and industry participants across the value chain. This report provides an in-depth analysis of parent company market trends, macroeconomic indicators and dominant factors, and market attractiveness by segment.

Our exploration specialists acutely ascertain the significant aspects of the global Cryonics Technology market report. It also provides an in-depth valuation in regards to the future advancements relying on the past data and present circumstance of Cryonics Technology market situation. In this Cryonics Technology report, we have investigated the principals, players in the market, geological regions, product type, and market end-client applications. The global Cryonics Technology report comprises of primary and secondary data which is exemplified in the form of pie outlines, Cryonics Technology tables, analytical figures, and reference diagrams. The Cryonics Technology report is presented in an efficient way that involves basic dialect, basic Cryonics Technology outline, agreements, and certain facts as per solace and comprehension.

Key point summary of the Cryonics Technology market Report:

1) Examining the overall market, underlining the recent trends and SWOT analysis2) Cryonics Technology Market scenario, focused on the growth opportunities in the market in the coming years3) Analysis of the different market segments, including qualitative and quantitative research and studies the impact of both economic and non-economic factors4) Inspection of the market at regional and global levels focusing on the demand and supply factors affecting the growth of the Cryonics Technology market.5) Market size (USD Million) and volume (Units Million) statistics for all market segment and sub-segment6) Competitive analysis with Cryonics Technology market share of leading market players, shedding light on project launches and tactical approaches implemented by the players in the last five years7) Extensive company profiling comprising of the product offerings, key financial facts and figures, recent developments, SWOT analysis, and strategic initiatives by the major firms in the Cryonics Technology market

The analysis includes market size, upstream situation, market segmentation, market segmentation, price & cost and industry environment. In addition, the report outlines the factors driving industry growth and the description of market channels.The report begins from overview of industrial chain structure, and describes the upstream. Besides, the report analyses market size and forecast in different geographies, type and end-use segment, in addition, the report introduces market competition overview among the major companies and companies profiles, besides, market price and channel features are covered in the report.

Competitive Landscape:

The competitive analysis of major market players is another notable feature of the Cryonics Technology market report; it identifies direct or indirect competitors in the market.

The Cryonics Technology market report provides answers to the following key questions:

At what rate is the Cryonics Technology market expected to grow in size in the forecast period? What are the key factors influencing the global Cryonics Technology market growth? Which significant market trends are driving the growth of the global Cryonics Technology market? Which factors are the determinants of the market shares of the leading geographies across the globe? Who are the leading participants in the industry and what are the strategies adopted by them in the global Cryonics Technology market? What are the opportunities and challenges encounters by vendors in the global Cryonics Technology market? Which trends, drivers and challenges are affecting the growth of the industry? What is the outcome of the PESTEL analysis of the global Cryonics Technology market?

Analysis of Global Cryonics Technology Market: By TypeSlow freezingVitrificationUltra-rapid

Analysis of Global Cryonics Technology Market: By ApplicationAnimal husbandryFishery scienceMedical sciencePreservation of microbiology cultureConserving plant biodiversity

Cryonics Technology Market Regional Analysis Includes:

Asia-Pacific (Vietnam, China, Malaysia, Japan, Philippines, Korea, Thailand, India, Indonesia, and Australia) Europe (Turkey, Germany, Russia UK, Italy, France, etc.) North America (the United States, Mexico, and Canada.) South America (Brazil etc.) The Middle East and Africa (GCC Countries and Egypt.)

Strategic Points Covered in Table of Content of Global Cryonics Technology Market:

Chapter 1: Introduction, market driving force product Objective of Study and Research Scope the Cryonics Technology market

Chapter 2: Exclusive summary the basic information of the Cryonics Technology Market.

Chapter 3: Displaying the Market Dynamics- Drivers, Trends and Challenges of the Cryonics Technology

Chapter 4: Presenting the Cryonics Technology Market Factor Analysis Porters Five Forces, Supply/Value Chain, PESTEL analysis, Market Entropy, Patent/Trademark Analysis.

Chapter 5: Displaying the by Type, End User and Region 2013-2018

Chapter 6: Evaluating the leading manufacturers of the Cryonics Technology market which consists of its Competitive Landscape, Peer Group Analysis, BCG Matrix & Company Profile

Chapter 7: To evaluate the market by segments, by countries and by manufacturers with revenue share and sales by key countries in these various regions.

Chapter 8 & 9: Displaying the Appendix, Methodology and Data Source.

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Trending News: Covid-19 Impact On Cryonics Technology Market Trends, Growth, Regions, Types And Key Developments, Applications By 2025 | Praxair,...

Recommendation and review posted by Bethany Smith

Cryonics Technology Market Forecast 2020-2026

The Global Cryonics Technology Market research report provides and in-depth analysis on industry- and economy-wide database for business management that could potentially offer development and profitability for players in this market. This is a latest report, covering the current COVID-19 impact on the market. The pandemic of Coronavirus (COVID-19) has affected every aspect of life globally. This has brought along several changes in market conditions. The rapidly changing market scenario and initial and future assessment of the impact is covered in the report. It offers critical information pertaining to the current and future growth of the market. It focuses on technologies, volume, and materials in, and in-depth analysis of the market. The study has a section dedicated for profiling key companies in the market along with the market shares they hold.

The report consists of trends that are anticipated to impact the growth of the Cryonics Technology Market during the forecast period between 2020 and 2026. Evaluation of these trends is included in the report, along with their product innovations.

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The Report Covers the Following Companies:PraxairCellulisCryologicsCryothermKrioRusVWRThermo Fisher ScientificCustom Biogenic SystemsOregon CryonicsAlcor Life Extension FoundationOsiris CryonicsSigma-AldrichSouthern Cryonics

By Types:Slow freezingVitrificationUltra-rapid

By Applications:Animal husbandryFishery scienceMedical sciencePreservation of microbiology cultureConserving plant biodiversity

Furthermore, the report includes growth rate of the global market, consumption tables, facts, figures, and statistics of key segments.

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Years Considered to Estimate the Market Size:History Year: 2015-2019Base Year: 2019Estimated Year: 2020Forecast Year: 2020-2026

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Global Cryonics Technology Market Size |Incredible Possibilities and Growth Analysis and Forecast To 2026 | Praxair, Cellulis, Cryologics, Cryotherm,...

Recommendation and review posted by Bethany Smith

The genetic make-up of an adult male buried in the heart of the ancient Newgrange passage tomb indicates he was among a ruling social elite and in-bred in a similar way to Inca god-kings and Egyptian pharaohs.

This remarkable discovery shedding new light on the earliest periods of Irelands human history has been made by archaeologists and geneticists led by a team in Trinity College Dublin. Their genetic analysis shows he was born as a consequence of first-degree incest.

Older than the pyramids, Newgrange passage tomb in Co Meath is world famous for its annual solar alignment where the winter solstice sunrise illuminates its sacred inner chamber in a golden blast of light. However, little is known about who was interred in the heart of this imposing 200,000-tonne monument or of the Neolithic society which built it more than 5,000 years ago.

The survey of ancient Irish genomes using DNA sequencing technology on bone samples suggests a man who had been buried in this chamber belonged to a dynastic elite, according to Dr Lara Cassidy of TCD, lead author of the research published by Nature scientific journal on Wednesday.

Id never seen anything like it, she said. We all inherit two copies of the genome, one from our mother and one from our father. This individuals copies were extremely similar, a tell-tale sign of close inbreeding. In fact, our analyses allowed us to confirm that his parents were first-degree relatives.

Matings of this type (such as brother-sister unions) are a near universal taboo for cultural and biological reasons. The only confirmed social acceptances of first-degree incest are found among the elites typically within a deified royal family, Dr Cassidy explained.

By breaking the rules, the elite separates itself from the general population, intensifying hierarchy and legitimising power. Public ritual and extravagant monumental architecture often co-occur with dynastic incest, to achieve the same ends, she added.

Here the auspicious location of the male skeletal remains is matched by the unprecedented nature of his ancient genome, said professor of population genetics at TCD Dan Bradley.

The prestige of the burial makes this very likely a socially sanctioned union and speaks of a hierarchy so extreme that the only partners worthy of the elite were family members.

The team also unearthed a web of distant familial relations between this man and others from sites of the passage tomb tradition across the country, namely the mega-cemeteries of Carrowmore and Carrowkeel in Co Sligo, and the Millin Bay monument in Co Down.

It seems what we have here is a powerful extended kin-group, who had access to elite burial sites in many regions of the island for at least half a millennium, Dr Cassidy said.

The monument builders were early farmers who migrated to Ireland and replaced hunter-gatherers who preceded them.

Remarkably, a local myth resonates with these results and the Newgrange solar phenomenon. First recorded in the 11th century AD, four millennia after construction, the story tells of a builder-king who restarted the daily solar cycle by sleeping with his sister. The Middle Irish place name for the neighbouring Dowth passage tomb Fertae Chuile is based on this lore and can be translated as Hill of Sin.

Given the world-famous solstice alignments of Br na Binne, the magical solar manipulations in this myth already had scholars questioning how long an oral tradition could survive, said Dr Ros Maoldin, an archaeologist on the study. To now discover a potential prehistoric precedent for the incestuous aspect is extraordinary.

The genome survey has unearthed other unexpected results. Within the oldest known burial structure on the island, Poulnabrone portal tomb, the earliest yet diagnosed case of Down Syndrome was discovered in a male infant who was buried there 5,500 years ago. Isotope analyses suggest the infant was breast-fed.

It was conducted in collaboration with researchers at University College London; NUIG, UCC, University of Cambridge, Queens University Belfast, Sligo IT and the National Monuments Service with support from the National Museum of Ireland and National Museums Northern Ireland.

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Newgrange tomb body belonged to royal-like male born of incest - The Irish Times

Recommendation and review posted by Bethany Smith