Male infertility is a heterogeneous condition of largely unknown etiology that affects at least 7% of men worldwide. Classical genetic approaches and emerging next-generation sequencing studies support genetic variants as a frequent cause of male infertility. Meanwhile, the barriers to transmission of this disease mean that most individual genetic cases will be rare, but because of the large percentage of the genome required for spermatogenesis, the number of distinct causal mutations is potentially large. Identifying bona fide causes of male infertility thus requires advanced filtering techniques to select for high-probability candidates, including the ability to test causality in animal models. The mouse remains the gold standard for defining the genotype-phenotype connection in male fertility. Here, we present a best practice guide consisting of (a) major points to consider when interpreting next-generation sequencing data performed on infertile men, and, (b) a systematic strategy to categorize infertility types and how they relate to human male infertility. Phenotyping infertility in mice can involve investigating the function of multiple cell types across the testis and epididymis, as well as sperm function. These findings will feed into the diagnosis and treatment of male infertility as well as male health broadly.

PubMed

Excerpt from:
A framework for high-resolution phenotyping of candidate male infertility mutants: from human to mouse. - Physician's Weekly

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As the novel coronavirus cuts its relentless swath across the globe, doctors have identified one grim constant: COVID-19 has men, more than women, in its sights.

In Italy, men account for at least 70 percent of all coronavirus deaths. While South Korea has seen more confirmed COVID-19 cases in female patients than in males, a higher percentage of men have been felled by it. Here in New York City, more men than women are testing positive for coronavirus, with 55 percent of all cases. They also are dying of it at even higher rates. As of Friday, 1,159 men in the five boroughs had been killed by COVID-19 62 percent of the citys 1,867 deaths.

The phenomenon has stumped medical experts. In their rush to make sense of the data, many are pointing fingers at men and their behavior. Some speculate that higher male smoking rates leave them vulnerable to the respiratory infection. Others guess that men are blowing off social-distancing guidelines, or are neglecting to wash their hands.

I find that so offensive, genetic researcher Sharon Moalem, MD, told The Post. Talk about blaming the victim.

Sure, there are some behaviors that might affect the number of infections, he said. But why should poor hand-washing lead to death for a patient whos already in intensive care? Its ridiculous.

In fact, the coronavirus bulls-eye on men is consistent across age groups, regardless of underlying risk factors.

What we are actually seeing is that males do not do well once infected, Moalem said. So it comes down to genetics. There is a genetic component to this illness.

As a clinical researcher studying genetic disease, Moalem spent years working with patients at both ends of the human life span from babies in the neonatal intensive care unit to seniors grappling with Alzheimers. In both groups he noticed that his female patients were more resilient than males, better at fighting off infections and recovering from injuries.

The hardest thing a human being can do is surpass the age of 110, he noted. And 95 percent of those supercentenarians are women. Meanwhile, around the world, more girls than boys make it to their first birthdays.

That brought Moalem to a startling conclusion contradicting centuries worth of conventional wisdom: Men, not women, are the weaker sex.

In The Better Half (Farrar, Straus and Giroux), out Tuesday, Moalem explains that from the time they are still in the womb to their final breaths, womens immune systems outperform those of men an inherent advantage that lengthens their lives and improves their overall health.

And when it comes to outwitting COVID-19, Moalem says, womens genes provide an even bigger edge.

With this virus, there is immense risk simply due to the fact of being male.

Its not just that females have a stronger immune system to fight this infection, he said. Its that their genes give them a better defense at the cellular level.

Every human, male and female, carries a set of 46 chromosomes in our cells. One of those 23 chromosome pairs determines a humans biological sex. A mans cells contain an X chromosome inherited from his mother and a Y chromosome provided by his father. A womans cells carry two X chromosomes one from each of her parents.

The genes within our chromosomes contain the code that builds our bodies. The Y chromosome, with only about 70 genes, is a specialist that fashions the male reproductive system. But the X chromosome, with nearly 1,000 genes, does much more.

The X chromosome has the genes that go into making the brain and the immune system, the two crucial things you need to survive as a human being, Moalem said.

Both of a females X chromosomes are present in all her cells. But within each cell, only one of the Xs calls the shots. Half of a womans cells are dominated by the X chromosome that came from her mother, half by the X contributed by her father.

That genetic diversity is really valuable, Moalem explained. One of the immune systems most important weapons is the ability to recognize a virus. Well, genes on the X chromosome are involved in viral recognition. Right away, women have two different populations of immune cells that are best at spotting invaders.

Meanwhile, maybe the other X has a gene thats very good at identifying and killing infected cells, he said. So womens immune cells function like a tactical unit. They specialize, then they interact and cooperate to fight the invaders.

Men, with their single X chromosome, have a far less nimble immunological army at their command.

As a man, I dont have all those options, Moalem said. I can only hope that my one X has the genes that can recognize the virus and can kill it, too.

It gets worse for men in the age of COVID-19: The new coronavirus takes direct aim at their single-X vulnerability.

What we researchers are seeing right now is the way this coronavirus gets into our lung cells, Moalem said. It has a key: a spike protein we think it uses to break in. And the lock it picks to enter is called ACE2 an enzyme attached to the outer surface of the cell membrane.

The gene that makes ACE2 is on the X chromosome, he continued. So if the coronavirus has the right key, it can unlock every one of a males lung cells. But females have two Xs so half of their lung cells use one ACE2 lock, and the other half use a slightly different ACE2 lock. The chance that the virus has the perfect key to unlock both of them is not great. So thats another enormous advantage for females.

The virus lock-picking action damages the ACE2 so badly that it can no longer perform one of its crucial functions: preventing the buildup of fluid in the lungs during the infection.

Its the lungs filling up with fluid that happens in COVID-19 that can lead to the breathing difficulties experienced by so many, Moalem said. The severest lung injury were seeing with this infection is not likely to occur unless all your locks get picked. In females, the virus cant usually get into enough of their cells to do that amount of damage and that may be the reason why were seeing so many men dying.

If that idea is correct, he said, we should expect more tragedies like that of the Fusco family of New Jersey, who lost four closely related members 73-year-old matriarch Grace Fusco, two of her sons, and a daughter to the coronavirus last month.

We will likely see siblings or families that are particularly susceptible to this virus, because their cells share the same lock that the coronavirus is picking, Moalem said. We will see young people succumbing very quickly, very likely because they were born with a genetic version of the ACE2 lock that the coronavirus easily picks.

And yet he sees reason to hope as research laboratories around the world home in on ACE2 to thwart the coronavirus attack.

In that effort we can learn from the superimmunity of females, he said.

Moalems own lab was in the midst of investigating new antibiotics when the crisis hit.

We quickly switched our research efforts to find out if we can repurpose a drug that already exists, he said. There are a lot of drugs available, drugs whose safety profile we know, that could be used. Im hopeful we can find something already in the toolkit that will be effective.

Until then, he said, understanding the genetic risk factors of COVID-19 should spur us to safeguard those who are most in danger.

We should be shielding all our seniors, but we should actually be protecting our male elders most of all, he said. With this virus, there is immense risk simply due to the fact of being male.

The homogenous chromosomes benefit other animals too.

Human females are not the only ones that benefit from the double-X advantage. Across the animal kingdom, in all kinds of creatures whose sex is determined by their chromosomes, researchers are learning that the sex that has the doubled chromosome is almost always the one that lives longer.

Essentially Im proposing a new biological law, genetic researcher Sharon Moalem told The Post. The sex that gets two of same chromosomes will have an immense genetic advantage.

Moalem calls it the Law of Homogameity (same-gene).

In a study published just last month, researchers from Australias University of New South Wales found new evidence to support his thesis. Biologists analyzed life-span data on 229 different animal species mammals, birds, insects, fish, spiders, and more.

We found that across that broad range of species, the heterogametic sex does tend to die earlier than the homogametic sex, and its 17.6 percent earlier on average, lead researcher Zoe Xirocostas said.

It isnt always the female of a species that gets the edge. Birds, some reptiles and butterflies dont have the X and Y chromosomes that humans and other mammals share. Instead, they have whats called a ZW sex-determination system. Female birds cells contain Z and W chromosomes; males get the double-Z.

Just as Moalem suspected, its the males in those animal species that gain the longevity edge.

Across the animal kingdom, these creatures benefit from a double chromosome hit

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Why women are better than men at beating the coronavirus - New York Post

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Written by Oscar Holland, CNNHong Kong

Despite his father having an "m-shaped" hairline, Alex Han from northeast China never thought he'd experience hair loss in his 20s.

"I was prepping my masters entrance examinations and there was a lot of pressure, so I probably didn't sleep very well," Han said in a phone interview. "At that time, (my receding hairline) was under control, but after three years in Beijing getting my masters, I moved to Germany for PHD study ... and not only me, but other Asian students there, had a problem with hair loss."

Commuters crowd the subway in Beijing in July 2008. China has traditionally had some of the world's lowest rates of baldness, though changes to people's lifestyles are contributing to an increase in hair loss. Credit: Guang Niu/Getty Images

Han opted to travel to Thailand for the transplant, which sees thousands of hair follicles grafted from other parts of the body -- such as the chest, or back of the neck -- onto the head. The eight- to 10-hour procedure cost him around $9,000, though he found clinics in China quoting "a sixth of that." The transplant may take months to take effect, though Han expressed hope that he will "see the results and see my hair return to normal in the next two or three months," adding, "then I'll behave as if nothing has happened."

Navigating stigmas

Han's fears mirror those experienced by men with receding hairlines around the world, namely the impact on his confidence, professional prospects and first impressions. "Hairstyles, for me, are critically important for men's first impressions," he said.

But losing your hair may be especially difficult in countries where it's less common. The male beauty standards in East Asian popular culture -- from Korean K-pop to Hong Kong's movie industry -- often favor big hair and boyish looks. "In Asian cultures the younger generation really like idols like (Chinese pop band) TFBoys," Han said, adding that standards for white or black men are often different.

"Whenever there is a precedent, people tend to feel (more confident) to follow," he said in an email interview.

A man looks at a robotic hair transplant machine at the China International Import Expo in Shanghai in 2019. Credit: China News Service/Visual China Group/Getty Images

Chinese American entrepreneur Saul Trejo, who has lived in various cities around Asia since 2011, began losing his hair while studying in Beijing. The 30-year-old said he "definitely noticed" the lower proportion of bald men in the city, compared to the US, and "it probably bothered me, but I tried to not let it." He also found that people were more comfortable than those in the West to pass comment -- even if in an entirely observational way.

"People will tell you straight out," he said in a phone interview from Taipei, recounting instances when his loss of hair was casually pointed out to him. "Normally when they're saying it they're not trying to be mean, they're just commenting, so I can't be mad. But you remember.

"I tried to shave my head, but I didn't think it was suitable for my head and body shape," he added, naming Dwayne "The Rock" Johnson and actor Jason Statham as non-Asians who can pull off the look. "I think Asian people, including myself, tend to be a little slimmer, so if I had to choose between bald and slim versus bald and athletic, or even muscular, then I think it looks better with the more size you have."

In 2018, Trejo underwent a hair transplant in Bangkok, where he was based at the time. While it took almost a year to see the final results, Trejo said his new hairline is "a major blessing," that "massively improved my dating life." Before-and-after images shared with CNN show a remarkable amount of hair restoration at the top and sides of his head.

Chinese American Saul Trejo, pictured before and after undergoing a hair transplant in Thailand. Credit: Saul Trejo

The doctor behind Trejo's procedure, Damkerng Pathomvanich, is a leading researcher into hair loss. He said that the number of hair transplant clinics in Asia is "skyrocketing," and that business among Chinese patients at his clinic is "booming."

Alternative approaches

A judge examines finalists at a 1957 baldness competition in Japan, where rates of hair loss have historically been among the world's lowest. Credit: Keystone Features/Hulton Archive/Getty Images

In Korea, meanwhile, houttuynia cordata -- also known as fish mint, or chameleon plant -- can be brewed into a black liquid that is applied to the scalp, according to the journalist, David Ko, who received some from his concerned mother-in-law.

"I used it like a shampoo whenever I washed my hair," he said. "After wetting my hair, I poured a handful of the plant-steeped water on my scalp, finger-massaged my scalp for about one minute, then rinsed it off with fresh water.

"But as time went by without seeing any clear sign of improvement, I got so tired of the remedy that I dumped more of (it) on my hair each time to finish the jar faster and get the practice over with." He then tried other suggested home remedies. "My wife also nudged me to sprinkle some sea salts over my scalp instead of the plant water, and one of my co-workers told me her balding father benefitted from eating lots of black sesame seeds as a snack."

Related video: Beauty is protest for young North Korean women

While New York dermatologist Norman Orentreich is widely known as the father of hair transplants, Japanese doctor Shoji Okuda is believed to have performed the very first procedure in 1937 (though the breakout of World War II meant that his research was largely overlooked). With baldness on the rise in Asia, it's perhaps no surprise that the continent's scientists -- Japan's and South Korea's in particular -- are again leading some of the field's most promising research.

Like 'a triad'

But, still, Asia poses unique challenges for receding men. Undergoing the scalp tattoo procedure requires patients to permanently sport a shaved-head look, which, as the Korean study suggested, may be "stereotyped in Asian cultures as (being like) a gangster or criminal." According to Ko, however, such labels are a thing of the past.

"Back in the day, when young males shaved their heads, seniors would mildly chide them with a totally unproven and absurd hypothesis," he said, suggesting that elders once saw a skinhead as a sign that someone was a rebel, or had "a problem with society."

"Nowadays (these attitudes) almost never exist, but it is still true people look at bald males with a certain awe."

A model with a shaved head walks the runway at China Fashion Week in 2017. The rise of street style may be helping popularize the skinhead look. Credit: Visual China Group / Getty Images

Eric But of Synergy Model Management, which has offices in Hong Kong and Guangzhou, said that clients are still often looking for Asian models to be "cute (with) long hair -- that Korean drama, perfect boyfriend kind of look." But while he distinguishes between shaved and bald heads, the modeling agent said that the rise of street fashion is gradually normalizing the skinhead look in Asia.

"For our parents' generation, a skinhead in Asia is kind of like a gangster -- if you want to be a triad, or if you go to prison, you have to shave your head," he said over the phone. "But now, for people born in the '90s or later, they see having a skinhead as a streetwear trend. And streetwear is massive in Asia."

Even in the home of coiffed K-pop, visibility may be growing gradually. Ko cited restaurateur Hong Seok-cheon (below), rapper Gill and actor Kim Kwang-kyu as examples of a slowly-growing number of high-profile bald celebrities in South Korea.

"It would be more helpful if there were more Koreans with hair loss --- if there were more cases (people) could look up to and think they are not alone out there."

Top image: Chinese artist Fang Lijun pictured with one of his paintings, which since the 1990s have often featured bald-headed protagonists. The artist uses the hairless figures as symbols of disillusionment and rebellion in modern China.

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With hair loss on the rise, Asia's men grapple with what it means to be bald - CNN

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For weeks, infectious disease experts have been investigating why the coronavirus is proving particularly devastating to males, with early theories from China suggesting that higher rates of smoking among men may be to blame. But a new study from the Centers for Disease Control and Prevention (CDC) is suggesting it may have more to do with biology specifically, genetics than lifestyle.

The research, released on Monday in the CDCs Morbidity and Mortality Weekly Report, found a higher prevalence of COVID-19 in males across every pediatric age group including infants. Fifty-seven percent of the more than 2,572 pediatric cases of COVID-19 studied (out of 149,750 cases overall) were found in males, ranging in age from newborns to 18.

To be clear, the research did not suggest that parents should now be concerned about their male children or female children getting seriously ill from COVID-19. The risk for children remains very low.

Most of the children reported symptoms of cough or fever, but only a small fraction (five percent) were hospitalized, bolstering reports that kids often develop a mild case of the virus. Those hospitalized were far more likely to report underlying health conditions than those who werent, including asthma, chronic lung disease and cardiovascular disease. Only 0.1 percent of the children infected died.

The median age of the more than 2,500 children with COVID-19 was 11, with over a third of cases involving teens between the ages of 15 and 17. But the most striking statistic for the researchers was that 57 percent of cases occurred among males an even higher number than the adult group, in which 53 percent of the cases involved males. The researchers conclude that the higher rate of boys testing positive in every pediatric age groupsuggests that biologic factors might play a role in any differences in COVID-19 susceptibility by sex.

So what exactly may be driving the higher incidence in young boys, and should parents take this as a concern? GregoryA.Poland,MD, an infectious diseases expertandheadofthe Mayo Clinic's Vaccine ResearchGroup, tells Yahoo Lifestyle that the study is no reason to panic, and shouldnt be taken as a roadmap for parents with boys. Instead, Poland helps unpack what the new research can teach us.

Poland says the concept that females are less susceptible to disease is a generalizable phenomenon beyond just infectious diseases (such as COVID-19). In fact, women also tolerate starvation and dehydration and survive longer than men do in austere environments, Poland tells Yahoo Lifestyle. So there does appear to be a sex advantage on the side of females that males don't have, meaning a better immune response.

Although the gender disparity may lead to theories about hormones, Poland says studies like this one are the reason researchers dont consider hormones to be the source. These are children who are absent the kind of hormonal levels or differences that we would see post-pubertal, Poland says, adding that the disparity in infection is one seen in post-menopausal women, too. That doesn't mean there couldn't be some still fine hormonal differences. But it leads to the idea that while hormones are important, it's again just one factor in this complex web that still needs to be teased apart.

Its still unclear to experts exactly why women respond better to certain diseases and harsh environments, but Poland says that genes may inform the answer. We don't fundamentally understand this... but what we do know is that females depending on the virus will tend to activate or suppress different genes than males do when their cells are exposed to these viruses, says Poland. So we think a strong driver of this is going to be just genetic, not just hormonal.

There is no evidence that females may be better equipped to fight disease due to evolution, but Poland says the idea has been floated. We don't have any evidence but people always postulate ... the idea has been in general: Is it this way for the primary reason of propagation of the species? he says. You need women to have children. You can have a lot of children with a few men, but you can only have them one by one with women.

An immunologist at the Heinrich Pette Institute in Hamburg, Germany, Marcus Atlfeld, raised another theory in a Scientific American piece from 2016 suggesting that women might have evolved a particularly fast and strong immune response to protect developing fetuses and newborn babies. Poland says that, in the absence of evidence, it may not be possible to form a conclusion.

Poland says males facing disease at higher rates than women is something currently being studied through the lens of vaccines. When you give males versus females of any age a vaccine, females almost always respond better than males, Poland says. He says that it shows females, even when faced with a small viral load of an inactivated disease, are often able to respond better than males something seen with vaccines against smallpox, measles and influenza.

Women responding more efficiently to disease may be beneficial in the midst of a coronavirus pandemic, but Poland says it has a negative side, too a higher likelihood that the immune system will overreact. This supercharged immune system has a negative side to it, says Poland. And that is women have higher rates of autoimmune diseases diseases where their own immune system attacks their own body. (According to the National Institutes of Health, roughly eight percent of the population has an autoimmune disease; 78 percent of them are women).

Like the authors of the CDC study, who note many limitations of the research, Poland says the study doesnt necessarily mean that more young boys are getting the virus. Instead, it could be showing that they do not have the same quality of immune response that girls do. There could be a lot of girls out there who had it but had zero symptoms, says Poland. So she may not even go and be tested to know that she has COVID-19. The boy is more likely to have symptoms [and] that may drive testing.

For that reason and many others, Poland says the new research should not be a reason for parents of boys to panic, nor for parents of girls to consider them immune. I would not want this to give false reassurance to a parent because yes, there were girls that got sick, Poland tells Yahoo Lifestyle. There were girls that had severe illness. So I would put it in the category of, that's interesting. More research needs to be done. But for me as a parent, I put whatever appropriate layers of protection around my children, regardless of their gender.

For the latest coronavirus news and updates, follow along at https://news.yahoo.com/coronavirus. According to experts, people over 60 and those who are immunocompromised continue to be the most at risk. If you have questions, please reference the CDC and WHOs resource guides.

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CDC: Coronavirus is more prevalent in young boys than girls - Yahoo Lifestyle

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In April 1980, almost exactly forty years ago, the journal Nature published a pair of highly influential articles on the topic of what has become known as junk or selfish DNA. Both reflected the key concept of The Selfish Gene, the highly influential 1976 book by Richard Dawkins, namely, that organisms are merely DNAs way of making more DNA. The first was authored by W. Ford Doolittle and Carmen Sapienza and titled Selfish genes, the phenotype paradigm and genome evolution.1 The second was authored by Leslie Orgel and Francis Crick and titled Selfish DNA: the ultimate parasite.2 Together they posited an easy-to-grasp way to conceive of excess nucleotides along chromosomes repetitive sequences in general and transposable elements in particular. In short, it was proposed that most such DNA elements neither had nor have (developmental) effects or functions (in general) in the shaping of an organisms traits (its phenotype). And because they have no phenotypic expression (as Doolittle and Sapienza put it) or little or no effect on the phenotype (as Orgel and Crick put it), the only role that can be ascribed to them is that of replicative survival.

But there are two problems with this outlook, one empirical and one formal. That which is empirical involves the organization of (eukaryotic) chromosomes, whereas that which is formal involves how to define effect, expression, and function when it comes to repetitive DNA sequences of any type. And so to narrow our focus on these problems, let us give some thought to the Y chromosome of Drosophila melanogaster, that engaging fly which is the bond-servant of genetics, as it is replete with a junk and selfish typography. Note that I will only be briefly touching on the first problem in this piece.

Now the Y chromosome of this species is approximately 40,000,000 bases in length, and that is significant for it makes up around 20 percent of the male haploid DNA content.3-4 While it is essential for male fertility, it has but few protein-coding regions and these are interrupted by or surrounded by vast tracks of (often degenerated) transposable elements, tandemly arranged runs of satellite units (such as AACAC, AATAG, AATAT, and so forth), a block of ribosomal-RNA genes, and various other sequence families.5 In addition, its various components are densely compacted in somatic-cell nuclei, and this heterochromatin is supposedly inert until around the stage the primary spermatocytes are formed. I hasten to mention also that its composition of DNA varies from strain to strain of D. melanogaster, even though its protein-coding sequences are stable throughout.6 What all of this seems to suggest, then, is that the bulk of this chromosome may have no phenotypic expression or little or no effect on the phenotype in males of this species.

Recall, however, that I said that there are two problems with this outlook, one of which is empirical. Concerning that, let us note that by the mid 1950s it was well-established that introducing a Y chromosome into a female D. melanogaster (by the feats of fruit-fly genetics) leads to a broad range of phenotypic effects, as does increasing the copies or dosage of a Y chromosome in a male of the same.7 Not only that, but with the sixty-plus years that have elapsed, we are much closer to understanding how such phenotypic effects due to junk or selfish DNA sequences take place. For one thing, it is now clear that different Y-chromosome sequence variants can differentially alter the expression of hundreds of genes in the somatic cells of male flies.8-10 For another, the characters that are affected are those of interest to the population geneticist including such things as male reproductive traits. Then again, many of the genes so modulated by the Y chromosome in this Drosophila species are positioned in so-called repressed chromatin domains.11

Apropos is an in-press work by Emily Brown, Alison Nguyen, and Doris Bachtrog that tests a hypothesis to explain such Y-chromosomal-based phenotypic effects.12 Some have suggested that long stretches of repetitive elements on that chromosome (which again is millions of bases long) can serve as a sink that titrates out heterochromatic proteins, thereby depleting the latter in other domains of a nucleus.13 Congruent with this hypothesis, Brown and colleagues showed that a consequence of introducing a Y chromosome into a female, or by decreasing or increasing the copies or dosage of a Y chromosome in a male line, is a widespread redistribution in nuclei of histone markers that are specific for heterochromatin, but not for those that are specific for active euchromatin. This means that the Y-sequences do make their absence or presence and (if present) quantities known in morphogenesis. What is more, the balance of chromatin domains in female versus male flies is likely to be en masse modulated by such parameters.

We can thus rephrase what Doolittle and Sapienza or Orgel and Crick asserted back in 1980 in this manner: Seemingly excess nucleotides do have phenotypic expressions be they ever so indirect, which is to say that they do have major effects on the phenotype. It thus looks like there is a why to the fly Y, though it does not fit the axioms with which the junk DNA advocates beset us. Yet we should note that such a possibility was never actually excluded, for as Doolittle and Sapienza claimed: We do not deny thatrepetitive and unique-sequence DNAs not coding for protein in eukaryotes may have roles of immediate phenotypic benefit to the organism.2

Photo: Drosophila melanogaster, an engaging fly, bySanjay Acharya / CC BY-SA.

Excerpt from:
The Why of the Fly Y: Reflections on Junk DNA - Discovery Institute

Recommendation and review posted by Bethany Smith

An elderly woman wears a mask as a precautionary measure against covid-19, as people take their ... [+] daily exercise in Battersea Park in London on March 28, 2020, as life in Britain continues during the nationwide lockdown to combat the novel coronavirus pandemic. - The two men leading Britain's fight against the coronavirus -- Prime Minister Boris Johnson and his Health Secretary Matt Hancock -- both announced Friday they had tested positive for COVID-19, as infection rates accelerated and daily death rate rose sharply. (Photo by Tolga AKMEN / AFP) (Photo by TOLGA AKMEN/AFP via Getty Images)

According to a recent Reuters/Ipsos poll, 54% of women said they were very concerned about Coronavirus. For men, this number was only 45%.

And thats just the beginning. The poll also reported men to be less likely to wash their hands and use hand sanitizers frequently, less committed to avoiding public gatherings, less supportive of the closing of public schools, and more likely to believe people were unnecessarily panicked about COVID-19.

Clearly, men are more cavalier in their assessment of the risk posed by COVID-19. But is this reflective of some underlying wisdom or calculated cost-benefit analysis, or is it another case of male stubbornness? Research in gender psychology suggests that there may be truth to both of these ideas. They are discussed below.

Stereotypes abound regarding the stubbornness of men. Men are less likely to stop and ask for directions when they are lost. They are less likely to take the advice of others. They are more likely to engage in risky behaviors.

And, where theres smoke, theres fire. Research has found men to be significantly less likely to seek out professional help to address mental or physical health problems. Mens reluctance to visit a doctor may be one of the reasons why they tend to die younger than women and why they have a higher mortality rate for 14 out of the 15 most common causes of death.

Even more damning is the finding that men are more likely to refer others to seek out health-related help; they just tend not to take their own advice.

Why is this the case? Part of it has to do with societal expectations. In cultures around the world, men are expected to be strong, dominant, confident, and unemotional. This begins early in their socialization, when boys are taught that real men dont show emotion or ask for help. Over time, this leads to the development of behaviors that negatively impact their health for example, increased substance use, fighting, and risky sexual behaviors.

It may also have to do with underlying male personality traits. Research has found men to be less agreeable than women, and less extroverted. Women also tend to be more cooperative in social and economic situations. Whether or not these trait differences are due to socialization pressures or genetics is an open debate. The most likely answer is that both factors are at play.

In the case of COVID-19, these traits may explain why men are generally less concerned about the disease. In the face of threat, they are expected to exhibit an air of invincibility; it is a trait promoted by culture and society as much as it may be hardwired into their personality.

Theres also evidence to suggest that men are better than women at tapping into their rational mind. For instance, a recent study published in the Journal of Behavioral and Experimental Economics examined gender differences on three brain teasers used to measure a persons ability to engage in reflective, systematic, and non-intuitive thinking. In case you are curious, the questions are listed below and the answers can be found at the end of the article.

If youve reviewed the answers, youll see how these questions assess a persons ability to forgo intuitive yet incorrect responses in favor of correct answers that require a deeper level of thinking.

The researchers examined over 44,000 responses to these questions from 21 different countries. They found clear evidence of a male advantage. They write, We find that: (i) males perform better in every single question, (ii) females are more likely to answer none of the questions correctly, and (iii) males are more likely to answer all three questions correctly. Importantly, gender differences persist even when we control for test characteristics (for example, monetary incentives, computerized, student samples, positioning of the experiment, etc.).

Again, whether there is a genetic component to this difference, or whether it is based solely on environmental factors, is an open debate (and a controversial one). It does, however, suggest that men might be better equipped to size up the COVID-19 risk for what it is: a threat that, in most cases, is still exceptionally remote.

There is a third factor at play, and that has to do with the finding that men might be less equipped to fight off the disease in the event they are exposed to it. This was discussed in a recent New York Times opinion piece, written by Dr. Sharon Moelem. He states, The disproportionate toll this virus is taking on males isnt an anomaly. When it comes to survival, men are the weaker sex. If true, perhaps this tips the scale in favor of the stubbornness hypothesis.

Brain teaser answers:

Excerpt from:
Men Are Less Concerned About COVID-19 Than Women. Is This Due To Reason Or Stubbornness? - Forbes

Recommendation and review posted by Bethany Smith

As citizens of developed nations continue to live longer and longer, dementia cases will begin to appear more frequently.

One in 14 Americans over the age of 65 will experience cognitive decline, and nearly one in six will endure the same at some point in their eighties. Despite the prevalence of the disease, there is a lot we still dont know about its pathology.

Advanced stages of dementia typically follow a series of muted symptoms patients might mistake for less serious conditions, like stress or sleep deprivation. In fact, according to a new study conducted by researchers from Duke University, many of us evidence one of the premiere red flags associated with the illness almost every day.

There has been a misperception that financial difficulty may occur only in the late stages of dementia, but this can happen early, and the changes can be subtle, explained senior author P. Murali Doraiswamy, MBBS, a professor of psychiatry and geriatrics at Duke University, in a media release.

The new paper, published in The Journal of Prevention of Alzheimers Disease, examines the cross-sectional relationship between dementia and financial management skills in the elderly. The strength of the reports findings highlights how limited the diagnostic scope has been up until very recently.

The researchers began with a longitudinal study of 243 adults between the ages 55 and 90 from the Alzheimers Disease Neuroimaging Initiative.

The study pool contained a heterogeneous mix of cognitively healthy adults, adults with mild memory impairment and adults who had been previously diagnosed with Alzheimers disease before recruitment.

After coupling financial literacy tests with brain scans that measured levels of protein buildup of beta-amyloid plaque, the researchers were able to establish a punitive correlation between the two.

On balance, even healthy adults showcased a drop in financial skills as they age, but after controlling for relevant variables the data yielded a direct relationship between increased amyloid plaques (a common predictor of degenerative disease) and a decreased ability to comprehend basic financial concepts, successfully calculated values and effectively balance an account.

Using a multicenter study sample, we document that financial capacity is impaired in the prodromal and mild stages of AD and that such impairments are, in part, associated with the extent of cortical -amyloid deposition. In normal aging, -amyloid deposition is associated with slowing of financial tasks. These data confirm and extend prior research highlighting the utility of financial capacity assessments in at-risk samples, the authors wrote in the report.

These outcomes were consistent among male and female participants.

As covered in a previously published Ladders article, the protein-plaque buildup is a biological inevitability that is not in and of itself instructive of onset cognitive decline. This rule also applies to many of the symptoms mentioned above. Any and each warrant concern when genetics and severity are applied.

Plaque buildup in adults who go on to develop dementia occurs aggressively, as do the pathological substrates associated with it. The problem is diagnosis is more often than not informed by reduced memory capabilityan important feature of cognitive illness but by no means the only reliable one.

Older adults hold a disproportionate share of wealth in most countries and an estimated $18 trillion in the U.S. alone, Doraiswamy continues. Little is known about which brain circuits underlie the loss of financial skills in dementia. Given the rise in dementia cases over the coming decades and their vulnerability to financial scams, this is an area of high priority for research.

Link:
This very common issue could be an early sign of dementia - Ladders

Recommendation and review posted by Bethany Smith

Helen PilcherBloomsbury Sigma2020384 pp.Purchase this item now

Hailing from rare wild mutants, the golden gnu, an uncharacteristically fawn-colored wildebeest, was for the past decade at the center of a speculation bubble in the African trophy-hunting business. Owners of wildlife preserves banked on hunters being willing to part with large sums for the privilege of shooting these beasts, and breeding stock changed hands for up to US$500,000 per animal. The speculators were wrong. The price people were prepared to pay was nowhere near what ranchers had hoped. Prices plummeted and reserve owners were left with herds of worthless mutant wildlife.

This is one of many tales Helen Pilcher tells in Life Changing, the central theme of which is how humans are, more deeply and pervasively than ever before, changing nature. She interprets her brief broadly, loosely weaving together intentional as well as accidental changes, (self-)domestication, conventional breeding, genetic modification (including CRISPR-Cas9), cloning, de-extinction, sterile male and kamikaze-gene techniques, hybridization, contemporary evolution, assisted evolution, conservation genetics, and rewilding.

Pilcher presents these stories in a pleasant, chatty style, garnished with funny asides. Part of the book consists of retellings of stories from other recent books on this topic (13). Still, it covers some new ground and makes for exciting reading, especially when Pilcher gives firsthand accounts of, for example, a captive breeding program for the endangered kkp parrot in New Zealand or an assisted evolution facility for coral at Londons Horniman Museum.

Pilcher tends to skirt around the more challenging parts of her subjects, such as the evolutionary biology of how species have adapted, and continue to adapt, to humans. When her examples involve her own academic field (cellular biology), however, she is on more secure footing. Her tale of the world of horse-cloning techniques and their implications, for instance, is fascinating.

Around 10 years ago, Argentinian polo champion Adolfo Cambiaso produced no fewer than six copies of his favorite mare, Cuartetera. In polo, players can change to fresh horses throughout the game, meaning that Cambiaso can ride multiple clones in a single match.

Toward the end of the book, Pilcher surveys her portfolio of human-induced changes in the worlds species and ponders what their impact will be on ecosystems of the future. She reminds readers of Darwins words that natural selection is immeasurably superior to mans feeble efforts and that there is hubris in thinking that we can fix the environment using technology.

Her chapter on rewilding shows how new ecosystems will appear, as if by magic, if we stop interfering with nature. The Knepp estate in England, for example, where feral pigs play their original role as a keystone species, is now a mosaic of habitats where rare species, once characteristic of the English half-open forest landscape, abound.

Pilcher waxes lyrical about successful attempts to save biodiversity by micromanaging species genetic makeup, as has been done to prevent inbreeding in the precariously small Kkp population. Unfortunately, the vertebrate component of biodiversity is negligible compared with the huge numbers of nonvertebrate organisms that make up the bulk of the food web. To this point, when the remaining wild Kkps entered the captive breeding program, they were dewormed, which probably drove to extinction Stringopotaenia psittacea, the kkps unique tapeworm species. For all its technological prowess, the net biodiversity benefit of the Kkp Recovery Program is probably exactly zero.

While the ultimate impact of intentional modification of species should not be oversold, the unintentional impact of our actions on the worlds ecosystems might be even vaster than Pilcher dares imagine. Forecasting these changes will be impossible, and only time will tell how those ecosystems will look and function.

References and notes1. L. A. Dugatkin, L. Trut, How to Tame a Fox (and Build a Dog) (Univ. of Chicago Press, 2017).2. T. Kornfeldt, The Re-Origin of Species (Scribe, 2018).3. K. van Grouw, Unnatural Selection (Princeton Univ. Press, 2018).

The reviewer is at the Naturalis Biodiversity Center, Darwinweg 2, 2333 CR Leiden, Netherlands.

Visit link:
Through actions big and small, intentional and unintentional, we are reshaping life on Earth - Science Magazine

Recommendation and review posted by Bethany Smith

OKLAHOMA CITY (KFOR) According to the Mayo Clinic, a leader in healthcare, acts of kindness arent just good for the soul, they are good for the body too, so the Oklahoma State Department of Health is sharing some ideas to spread the love.

When we participate in acts of kindness our body releasesoxytocin, a hormone that helps regulate our social and emotional response.

The more oxytocin released, the more generous, kind and peaceful you are likely to feel.

In addition, higher amounts of oxytocin is associated with less stress and better sleep.

The best part? It is so easy for each of us to participate in acts of kindness. Here are a few ways to get that oxytocin boostand still follow social distancing guidelines:

Are you picking up dinner at a local drive thru? If you have the extra cash, pick up the tab for the person pulling up behind you.Did you run to the grocery store to pick up some rolls of toilet paper or get the last few boxes of tissues? Leave your extras on a neighbors doorstep or in a mailbox.Get your kids involved in acts of kindness and create springtime version of Secret Santa by leaving small arts and crafts or drawings for randompeople in your community.

Everyone will smile a little more and sleep a little better, with a bit more kindness in the world.

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Acts of Kindness are good for your health - KFOR Oklahoma City

Recommendation and review posted by Bethany Smith

Infantile Spasms Therapeutics market report:

The Infantile Spasms Therapeutics markets business intelligence research comprehensively provides a quick of crucial facts consisting of the merchandise catalogue, analytical elaboration, and other industry-linked information.

The study also covers the key aspects related to the on-going events such as mergers & acquisitions, new product launches, and synergisms. The study further harmonies a rigid preliminary for gaining loads of insights that potential buyers can use for ensuring better profits at low capitals. The demonstration of information on market segmentation by type, application, and geography delivers a critical viewpoint of, what manufacturers are seeking for the stipulated timeframe, 2020 2026.

Scope of the Report:

The global infantile spasms therapeutics market is growing at a slow pace. This is due to the increased availability of generic drugs and less approved therapies in the market and the less awareness of the disease and the available treatment options, especially in the low- and middle-income countries.The classification of Infantile Spasms Therapeutics includes Oral, Injection. The proportion of Injection in 2016 is about 45%, and the proportion of Oral in 2016 is about 55%.Based on application, the nitinol medical devices market is segmented into Hospital, Clinic and others. Clinic segment accounted for larger market share in terms of sales in 2016, Clinic segmented accounted for more than 45% of the market share in 2016.United States is the largest consumption place, with a consumption market share nearly 83% in 2016. Following United States, Europe is the second largest consumption place with the consumption market share of 12.6% in 2016.The US market is dominated by two approved products H.P. Acthar Gel (adrenocorticotropin hormone) and Sabril (vigabatrin). Sabril was the first drug to be approved by the Food and Drug Administration (FDA) in 2009 and H.P. Acthar Gel (adrenocorticotropin hormone) was approved for infantile spasms in 2010. Both have Orphan Drug Exclusivity (ODE) in the US.In the future, the Infantile Spasms Therapeutics will have a good future; the price fluctuation has relationship with the raw material. The technology will more mature and the industry is more dispersion.

The worldwide market for Infantile Spasms Therapeutics is expected to grow at a CAGR of roughly 3.0% over the next five years, will reach 150 million US$ in 2024, from 130 million US$ in 2019, according to a new Globalmarketers.biz Research study.

This report focuses on the Infantile Spasms Therapeutics in global market, especially in North America, Europe and Asia-Pacific, South America, Middle East and Africa. This report categorizes the market based on manufacturers, regions, type and application.

This article will help the Infantile Spasms Therapeutics manufacturers identify the volume inflation prospect with affecting trends.

This handout will assist you to know the quantity, growth with Impacting Trends. Click HERE to urge SAMPLE PDF (Including Full TOC, Table & Figures) @https://www.globalmarketers.biz/report/life-sciences/global-infantile-spasms-therapeutics-market-2019-by-manufacturers,-regions,-type-and-application,-forecast-to-2024/130415#request_sample

An in-depth list of key vendors in Infantile Spasms Therapeutics market includes:

MallinckrodtH. LundbeckInsys TherapeuticsOrphelia PharmaValerion TherapeuticsCatalyst PharmaceuticalsAnavex Life SciencesRetrophinGW Pharmaceuticals

Infantile Spasms Therapeutics Market segment by Type, the merchandise are often split into

OralInjection

Market segment by Application, split into

HospitalClinic

Market segment by Regions/Countries, this report covers

North America

Europe

China

Japan

Southeast Asia

India

Central & South America

Make an Inquiry About This Report @https://www.globalmarketers.biz/report/life-sciences/global-infantile-spasms-therapeutics-market-2019-by-manufacturers,-regions,-type-and-application,-forecast-to-2024/130415#inquiry_before_buying

The study objectives of this report are:

In this study, the years considered to estimate the market size of Infantile Spasms Therapeutics are as follows:

For the info information by region, company, type and application, 2019 is taken into account because the base year. Whenever data information was unavailable for the bottom year, the prior year has been considered.

The market study discusses the highlighted segments on the idea of BPS, market share, profit, and other vital factors. Our business report elaborates the impact of various subdivisions to the growth of the global Infantile Spasms Therapeutics market. It also delivers information on key trends associated with the subdivisions covered in the report. This aids market participants to address worthwhile areas of the global Infantile Spasms Therapeutics market. The marketing study also delivers analysis on the subdivisions supported absolute dollar opportunity.

The research answer many questions as follows:

Ask for Detailed Table of Content with Table of Figures:

https://www.globalmarketers.biz/report/life-sciences/global-infantile-spasms-therapeutics-market-2019-by-manufacturers,-regions,-type-and-application,-forecast-to-2024/130415#table_of_contents

Why Choose Infantile Spasms Therapeutics Market Research?

For More Information Kindly Contact:

Mr. Alex White,

Tel: +1(617)2752538

Email: [emailprotected]

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Infantile Spasms Therapeutics Market Size, Share, Trends and Competitive Outlook during forecast period 2020-2026 - Curious Desk

Recommendation and review posted by Bethany Smith

Global Bone Marrow Transplant Rejection Treatment Marketreport contains exhaustive data on the most important factors the growth of the company. The report contains a study on the change in the dynamics of competition. It also delivers specific awareness that helps you choose the right business executions and steps. The Bone Marrow Transplant Rejection Treatment Market report systematically presents information in the form of organizational charts, facts, diagrams, statistical charts, and figures that represent the state of the relevant trading on the Global and regional platform. Additionally, the report comprises the overall business chain, through which the growth rate and decline rate of the specific industry in the market can be analyzed. The total cost spent on manufacturing the product and analysis of its assembling procedure is also described in the report.

Bone Marrow Transplant Rejection Treatment Market is expected to grow USD million in 2019 with CAGR from 2014 to 2020, and it is expected to reach USD million by the end of 2023 with a CAGR of % from 2019 to 2024.

This Report covers the manufacturers data, including shipment, price, revenue, gross profit, interview record, business distribution, etc., these data help the consumer know about the competitors better. This report also covers all the regions and countries of the world, which shows a regional development status, including market size, volume, and value, as well as price data.

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Besides, the Bone Marrow Transplant Rejection Treatment report also covers segment data, including type segment, industry segment, channel segment, etc. cover different segment market sizes, both volume, and value. It also covers different industries clients information, which is very important for the manufacturers.

Here is List of Major Key playersoperating in the Global Bone Marrow Transplant Rejection Treatment Market are

Share your query before purchasing this report @https://www.360marketupdates.com/enquiry/pre-order-enquiry/14275807

Bone Marrow Transplant Rejection Treatment Market Segmentation by Product Type:AzathioprineAdrenocorticotropic HormoneCyclophosphamideCyclosporine AIndustry Segmentation:HospitalClinic

Objective of Report Includes:

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360 Market Updates is the credible source for gaining the market reports that will provide you with the lead your business needs. At 360 Market Updates, our objective is providing a platform for many top-notch market research firms worldwide to publish their research reports, as well as helping the decision makers in finding most suitable market research solutions under one roof. Our aim is to provide the best solution that matches the exact customer requirements. This drives us to provide you with custom or syndicated research reports.

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Global Bone Marrow Transplant Rejection Treatment Market with latest research report and Growth by 2023 Ma ... - NMSU Reporter

Recommendation and review posted by Bethany Smith

An article published in Experimental Biology and Medicine(Volume 245, Issue 6, March 2020)examines the safety of stem cell therapy for the treatment of colon cancer.The study, led by Dr. J. Liu in the State Key Laboratory of Bioreactor Engineering and Shanghai Key Laboratory of New Drug Design at the East China University of Science and Technology in Shanghai (China), reports that mesenchymal stem cells from a variety of sources promote the growth and metastasis of colon cancer cells in an animal model.

Mesenchymal stem (MSCs), a category of adult stem cells, are being evaluated as a therapy for numerous cancers.MSCs are excellent carriers for tumor treatment because they migrate to tumor tissues, can be genetically modified to secrete anticancer molecules and do not elicit immune responses.Clinical trials have shown that MSCs carrying modified genes can be used to treat colon cancer as well as ulcerative colitis. However, some studies have demonstrated MSCs can differentiate into cancer-associated fibroblasts and promote tumor growth.Therefore, additional studies are needed to evaluate the safety of MSCs for targeted treatment of colon cancer.

In the current study, Dr. Liu and colleagues examined the effects of mesenchymal stem cells (MSCs) from three sources (bone marrow, adipose, and placenta) on colon cancer cells.MSCs from all three sources promoted tumor growth and metastasis in vivo. In vitro studies demonstrated that MSCs promote colon cancer cell stemness and epithelial to mesenchymal transition, which would enhance tumor growth and metastasis respectively.Finally, the detrimental effects of MSCs could be reversed by blocking IL-8 signaling pathways. Dr. Ma, a co-author of the study, said that Mesenchymal stem cells have a dual role: promoting and/or suppressing cancer. Which effect is dominant depends on the type of tumor cell, the tissue source of the MSC and the interaction between the MSC and the cancer cell. This is the major issue in the clinical application research of MSCs, and additional preclinical experimental data will be needed to evaluate the safety of MSCs for colon cancer treatment.

Dr. Steven R. Goodman, Editor-in-Chief of Experimental Biology & Medicine, said: Lui and colleagues have performed elegant studies on the impact of mesenchymal stem cells (MSCs), from various sources, upon the proliferation, stemness, and metastasis of colon cancer stem cells (CSCs) in vitro and in vivo. They further demonstrate that IL-8 stimulates the interaction between colon CSCs and MSCs, and activates the MAPK signaling pathway in colon CSCs.This provides a basis for the further study of MSCs as a biologic therapy for colon cancer.

Experimental Biology and Medicine is a global journal dedicated to the publication of multidisciplinary and interdisciplinary research in the biomedical sciences. The journal was first established in 1903. Experimental Biology and Medicine is the journal of the Society of Experimental Biology and Medicine. To learn about the benefits of society membership, visit sebm.org.

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Stem Cell Therapy for Colon Cancer - The Ritz Herald

Recommendation and review posted by Bethany Smith

DetailsCategory: AntibodiesPublished on Monday, 06 April 2020 18:54Hits: 177

Fifteen (15) severely ill COVID-19 patients have been treated under an EIND;

7-day results from the first four patients are available and are very promising;

7-day results for the first 10 patients will be available this week

VANCOUVER, Canada I April 06, 2020 I CytoDyn Inc. (OTC.QB: CYDY), (CytoDyn or the Company"), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today that the first two COVID-19 patients have been treated with leronlimab under the Companys Phase 2 randomized clinical trial, which is for patients with mild-to-moderate indications. The Company anticipates that enrollment of more patients will accelerate this week at multiple clinical sites.

In addition, the Companys investigational new drug, leronlimab, has now been administered to 15 severely ill COVID-19 patients atfour hospitals, 10 patients treated at a leading medical center in the New York City area and five patients at three other hospitals, all under an emergency investigational new drug (EIND), which were granted by the U.S. Food and Drug Administration (FDA) for each individual patient.

CytoDyn also anticipates initiating its other COVID-19 trial this week. This trial is a Phase 2b/3 for severely ill COVID-19 patients and is for 342 patients, double-blinded with a 2:1 ratio (drug to placebo ratio). Patients enrolled in this trial are expected to be administered leronlimab for two weeks, with the primary endpoint being the mortality rate at 14 days. The Company will perform an interim analysis on the data from 50 patients following two weeks of leronlimab therapy.

Bruce Patterson, M.D., Chief Executive Officer and founder of IncellDx, a diagnostic partner and advisor to CytoDyn, commented, We are encouraged by the positive results demonstrated with leronlimab in the New York patients. Our team is working hard to distribute leronlimab to multiple clinical sites to initiate therapy in patients with severe COVID-19 disease. While every patient is experiencing different comorbidities, we are seeing similar clinical responses, which we believe is a reflection of leronlimabs mechanism of action.

Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, said, Our partnership with the New York medical team and now other hospitals has been exemplary. We are collaborating in every aspect to deliver leronlimab to patients in order to provide proof of concept as soon as possible. The outstanding coordination among the physicians, the hospital administrators, the FDA, and our team, will hopefully help mitigate the deleterious effects from this pandemic should we prove leronlimab as a solution. The lead physician in New York is a true medical hero, who deserves to be recognized for his contribution to humanity in the pandemic of COVID-19. We are very hopeful of sending the day three and day seven results of the first ten EIND patients to the FDA by the end of this week.

About Coronavirus Disease 2019SARS-CoV-2 was identified as the cause of an outbreak of respiratory illness first detected in Wuhan, China. The origin of SARS-CoV-2 causing the COVID-19 disease is uncertain, and the virus is highly contagious. COVID-19 typically transmits person to person through respiratory droplets, commonly resulting from coughing, sneezing, and close personal contact. Coronaviruses are a large family of viruses, some causing illness in people and others that circulate among animals. For confirmed COVID-19 infections, symptoms have included fever, cough, and shortness of breath. The symptoms of COVID-19 may appear in as few as two days or as long as 14 days after exposure. Clinical manifestations in patients have ranged from non-existent to severe and fatal. At this time, there are minimal treatment options for COVID-19.

About Leronlimab (PRO 140) The FDA has granted a Fast Track designation to CytoDyn for two potential indications of leronlimab for deadly diseases. The first as a combination therapy with HAART for HIV-infected patients and the second is for metastatic triple-negative breast cancer.Leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that is important in HIV infection, tumor metastases, and other diseases, including NASH.Leronlimab has completed nine clinical trials in over 800 people, including meeting its primary endpoints in a pivotal Phase 3 trial (leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients).

In the setting of HIV/AIDS, leronlimab is a viral-entry inhibitor; it masks CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells. Leronlimab has been the subject of nine clinical trials, each of which demonstrated that leronlimab could significantly reduce or control HIV viral load in humans. The leronlimab antibody appears to be a powerful antiviral agent leading to potentially fewer side effects and less frequent dosing requirements compared with daily drug therapies currently in use.

In the setting of cancer, research has shown that CCR5 may play a role in tumor invasion, metastases, and tumor microenvironment control. Increased CCR5 expression is an indicator of disease status in several cancers. Published studies have shown that blocking CCR5 can reduce tumor metastases in laboratory and animal models of aggressive breast and prostate cancer. Leronlimab reduced human breast cancer metastasis by more than 98% in a murine xenograft model. CytoDyn is, therefore, conducting aPhase 1b/2 human clinical trial in metastatic triple-negative breast cancer and was granted Fast Track designation in May 2019.

The CCR5 receptor appears to play a central role in modulating immune cell trafficking to sites of inflammation. It may be crucial in the development of acute graft-versus-host disease (GvHD) and other inflammatory conditions. Clinical studies by others further support the concept that blocking CCR5 using a chemical inhibitor can reduce the clinical impact of acute GvHD without significantly affecting the engraftment of transplanted bone marrow stem cells. CytoDyn is currently conducting a Phase 2 clinical study with leronlimab to support further the concept that the CCR5 receptor on engrafted cells is critical for the development of acute GvHD, blocking the CCR5 receptor from recognizing specific immune signaling molecules is a viable approach to mitigating acute GvHD. The FDA has granted orphan drug designation to leronlimab for the prevention of GvHD.

About CytoDynCytoDyn is a late-stage biotechnology company developing innovative treatments for multiple therapeutic indications based on leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. CCR5 appears to play a critical role in the ability of HIV to enter and infect healthy T-cells.The CCR5 receptor also appears to be implicated in tumor metastasis and immune-mediated illnesses, such as GvHD and NASH. CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients. CytoDyn plans to seek FDA approval for leronlimab in combination therapy and plans to complete the filing of a Biologics License Application (BLA) in April of 2020 for that indication. CytoDyn is also conducting a Phase 3 investigative trial with leronlimab as a once-weekly monotherapy for HIV-infected patients. CytoDyn plans to initiate a registration-directed study of leronlimab monotherapy indication. If successful, it could support a label extension. Clinical results to date from multiple trials have shown that leronlimab can significantly reduce viral burden in people infected with HIV with no reported drug-related serious adverse events (SAEs). Moreover, a Phase 2b clinical trial demonstrated that leronlimab monotherapy can prevent viral escape in HIV-infected patients; some patients on leronlimab monotherapy have remained virally suppressed for more than five years. CytoDyn is also conducting a Phase 2 trial to evaluate leronlimab for the prevention of GvHD and a Phase 1b/2 clinical trial with leronlimab in metastatic triple-negative breast cancer. More information is atwww.cytodyn.com.

SOURCE: Cytodyn

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First Two Patients Enrolled in Randomized Phase 2, COVID-19 Trial with Leronlimab; Five More Severely Ill COVID-19 Patients Treated Under Emergency...

Recommendation and review posted by Bethany Smith

NEW YORK, April 01, 2020 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq: MESO; ASX:MSB), global leader in cellular medicines for inflammatory diseases, today announced that the United States Food and Drug Administration (FDA) has accepted for priority review the Companys Biologics License Application (BLA) filing for RYONCILTM (remestemcel-L), its allogeneic cell therapy for the treatment of children with steroid-refractory acute graft versus host disease (SR-aGVHD). The FDA has set a Prescription Drug User Fee Act (PDUFA) action date of September 30, 2020, and if approved, Mesoblast will make RYONCIL immediately available in the United States.

A Priority Review designation will direct overall attention and resources to the evaluation of applications for drugs that, if approved, would be significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications. The FDA has advised that they are planning to hold an Advisory Committee Meeting to discuss this application.

Mesoblast Chief Executive Dr Silviu Itescu stated: There is a critical need to improve survival outcomes in children suffering from the more advanced stages of this devastating disease. The acceptance of the BLA represents an important milestone for the Company. Mesoblast is on track in its preparation for the potential launch of RYONCIL, including meeting its target inventory build and commercial team roll-out.

About Acute GVHD Acute GVHD occurs in approximately 50% of patients who receive an allogeneic bone marrow transplant (BMT). Over 30,000 patients worldwide undergo an allogeneic BMT annually, primarily during treatment for blood cancers, and these numbers are increasing.1 In patients with the most severe form of acute GVHD (Grade C/D or III/IV) mortality is as high as 90% despite optimal institutional standard of care.2,3. There are currently no FDA-approved treatments in the US for children under 12 with SR-aGVHD.

About RYONCILTM Mesoblasts lead product candidate, RYONCIL (remestemcel-L), is an investigational therapy comprising culture- expanded mesenchymal stem cells derived from the bone marrow of an unrelated donor. It is administered to patients in a series of intravenous infusions. RYONCIL is believed to have immunomodulatory properties to counteract the inflammatory processes that are implicated in SR- aGVHD by down-regulating the production of pro-inflammatory cytokines, increasing production of anti-inflammatory cytokines, and enabling recruitment of naturally occurring anti-inflammatory cells to involved tissues.

References

About Mesoblast Mesoblast Limited(Nasdaq: MESO; ASX:MSB) is a world leader in developing allogeneic (off-the-shelf) cellular medicines. The Company has leveraged its proprietary mesenchymal lineage cell therapy technology platform to establish a broad portfolio of commercial products and late-stage product candidates. Mesoblasts proprietary manufacturing processes yield industrial-scale, cryopreserved, off-the-shelf, cellular medicines. These cell therapies, with defined pharmaceutical release criteria, are planned to be readily available to patients worldwide.

Mesoblast has filed a Biologics License Application to theUnited States Food and Drug Administration(FDA) to seek approval of its product candidate RYONCIL (remestemcel-L) for steroid-refractory acute graft versus host disease (acute GvHD). Remestemcel-L is also being developed for other rare diseases. Mesoblast is completing Phase 3 trials for its product candidates for advanced heart failure and chronic low back pain. If approved, RYONCIL is expected to be launched inthe United Statesin 2020 for pediatric steroid-refractory acute GVHD. Two products have been commercialized inJapanandEuropeby Mesoblasts licensees, and the Company has established commercial partnerships inEuropeandChinafor certain Phase 3 assets.

Mesoblast has a strong and extensive global intellectual property (IP) portfolio with protection extending through to at least 2040 in all major markets. This IP position is expected to provide the Company with substantial commercial advantages as it develops its product candidates for these conditions.

Mesoblast has locations inAustralia,the United StatesandSingaporeand is listed on theAustralian Securities Exchange(MSB) and on the Nasdaq (MESO). For more information, please seewww.mesoblast.com, LinkedIn:Mesoblast Limitedand Twitter: @Mesoblast

Forward-Looking Statements This announcement includes forward-looking statements that relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Forward- looking statements should not be read as a guarantee of future performance or results, and actual results may differ from the results anticipated in these forward-looking statements, and the differences may be material and adverse. Forward-looking statements include, but are not limited to, statements about the timing, progress and results of Mesoblasts preclinical and clinical studies; Mesoblasts ability to advance product candidates into, enroll and successfully complete, clinical studies; the timing or likelihood of regulatory filings and approvals; and the pricing and reimbursement of Mesoblasts product candidates, if approved. You should read this press release together with our risk factors, in our most recently filed reports with the SEC or on our website. Uncertainties and risks that may cause Mesoblasts actual results, performance or achievements to be materially different from those which may be expressed or implied by such statements, and accordingly, you should not place undue reliance on these forward-looking statements. We do not undertake any obligations to publicly update or revise any forward-looking statements, whether as a result of new information, future developments or otherwise.

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For further information, please contact: Julie Meldrum Corporate Communications T: +61 3 9639 6036 E: julie.meldrum@mesoblast.com

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FDA ACCEPTS MESOBLAST'S BIOLOGICS LICENCE APPLICATION FOR RYONCIL AND AGREES TO PRIORITY REVIEW - GlobeNewswire

Recommendation and review posted by Bethany Smith

, which were found to produce high levels of Interleukin-6 (IL-6), was abated in the presence of anti-IL-6 monoclonal antibodies, according to study results intended to be presented at the annual meeting of the American College of Cardiology (ACC.20).

In a diseased state, cardiacmesenchymal stromal cells (cMSCs) remodel and secrete inflammatory cytokines,including IL-6. IL-6 has been shown to be a potent inducer of Ca2+-mediatedarrhythmia substrates in human myocytes. While anti-IL-6 monoclonal antibodies havean established role in the treatment of autoimmune diseases and malignancies, theiruse in the treatment of cardiac disease has not been well studied.

Using extracted device leads and explanted hearts from patients with and without heart failure, investigators isolated cMSCs (failing and non-failing cMSCs, respectively), and quantified IL-6 using an enzyme-linked immunosorbent assay. Myocytes were derived from induced pluripotent stem cells (iPSCs) from individuals without heart failure and cultured in monolayers. Myocytes were treated with exogenous IL-6 or cocultured with failing cMSCs with and without anti-IL-6 monoclonal antibody. Fluorescent indicators were used to detect the presence of Ca2+ alternans during steady state pacing.

The secretion of IL-6 was found tobe 5.6 times higher in failing vs nonfailing cMSCs (n=4; P <.005) and 66 times higher in cMSCs vs iPSC-derived humanmyocytes (n=5; P <.002). Myocytes thatwere cocultured with failing cMSCs or were exposed to exogenous IL-6 had largeincreases in Ca2+ alternans compared with myocytes cultured alone (343%,n=12, P <.001 and 300%, n=5, P <.002, respectively). These Ca2+alternans were reduced to baseline levels in myocyte/cMSC cocultures treated vsnot treated with IL-6 (reduction, 400%; n=18, P <.001).

These results suggest anovel anti-arrhythmic therapeutic strategy in heart failure using anti-IL-6drugs such as tocilizumab, sarilumab, or siltuximab, concluded theresearchers.

Reference

Vasireddi S, Sattayaprasert P,Moravec C, et al. Targeted anti-inflammatory treatment with anti-Il-6monoclonal antibody for calcium-mediated arrhythmia substrates in heartfailure. Intended to be presented at: American College of Cardiologys 69thAnnual Scientific Session; March 28-30, 2020; Chicago, IL. Presentation 915-09.

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Anti-IL-6 Monoclonal Antibodies as Antiarrhythmic Treatment for HF - The Cardiology Advisor

Recommendation and review posted by Bethany Smith

Dallas-based American Heart Association (AHA) awarded more than $14 million in scientific research grants for health technology solutions focused on heart and brain health, including special projects related to COVID-19, last week. The grants went to four multidisciplinary teams around the country to create the AHAs 10th Strategically Focused Research Network. The newest network centers on Health Technologies and Innovation.

Consumer adoption of healthcare technology on digital mediums like tablets, smartphones, and wearable devices offer a unique outlet to find new solutions to improve health outcomes, American Heart Association president Robert A. Harrington said in a statement.

The AHA peer review team moved forward with its selection of the centers for its latest strategically focused research network when the COVID-19 pandemic in the U.S. broke. The nonprofit science-based organization knows the times are challenging as it works towards its mission of a culture of health.

It felt this was an incredible opportunity for us to provide additional support in harnessing new innovations to tackle the challenges that are crippling the nation, and frankly the globe, Harrington said.

Grantees that will create the 10th network are research teams at Cincinnati Childrens Hospital, The Johns Hopkins University, Stanford University School of Medicine and the University of Michigan. Each team will receive $2.5 million each for their individual projects aimed at reducing health care disparities, empowering people to better manage their health and wellness, and enhancing patient/provider connectivity, the AHA said.

Collectively the teams will also receive $4 million to work on at least one highly impactful project and form a national Health Technology Research Collaborative, it said. The Collaborative may ultimately serve as an American Heart Association research think tank to assist with identifying, creating, testing and bringing to scale future innovative health technologies.

In addition, each research team also can apply for supplemental research grants of up to $200,000 for rapid action projects to develop technology solutions to address the COVID-19 pandemic, the AHA said. Those projects might provide aid for health care systems, doctors or care providers, first responders, patients or consumers.

These supplemental grants are part of the AHAs $2.5 million commitment to research efforts to better understand this unique coronavirus and its interaction with the bodys cardiovascular and cerebrovascular systems.

The peer review committee has assembled an exceptional network to move this work forward and I want to recognize the dedication and commitment of that panel of many renowned experts, Harrington said. The Association uses an intense, multi-stage review process in selecting the centers for our focused research networks and were very appreciative of the committee members who lend their time and expertise to this critical process.

The AHA program brings together basic, clinical, and population researchers with engineers, IT developers, policy leaders, health care clinicians and patients. That lets the teams improve existing technology, and also identify new and innovative ways to put technology to work in addressing heart and brain health, American Heart Association volunteer James A. Weyhenmeyer, Ph.D. said.

Weyhenmeyer is vice president for research and economic development at Auburn University and chair of the Associations peer review team for the selection of the new grant recipients. Its especially important that all of these projects be focused with an equity-first lens to ensure our most vulnerable populations are being served, he noted.

The AHA is currently funding seven Strategically Focused Research Networks (SFRN) with focuses on Go Red For Women, Heart Failure, Obesity, Children, Vascular Disease, Atrial Fibrillation, and Arrhythmias & Sudden Cardiac Death. Three of AHAs networksPrevention, Hypertension, and Disparitieshave been completed. Locally, the University of Texas Southwestern was a grantee in the completed Prevention SFRN.

With the launch of its newest network, the American Heart Association has invested more than $190 million to establish 12 SFRNs since the program was launched in 2010-2011. The idea behind the science networks is the collaboration of scientists to focus research to address key strategic issues that were identified by the AHAs Board of Directors, in areas such as hypertension, womens health, heart failure, obesity, children, vascular disease, atrial fibrillation, sudden cardiac death, and type 2 diabetes. Each established network centers around the understanding, prevention, diagnosis and treatment of a key research topic. Four to six research centers make up each network, AHA said, which brings together investigators with expertise.

More networks can be expected in 2020 and beyond, AHA said.

The latest projects funded by the $14.5 million in grants commenced on April 1. Here they are, per the AHA:

Active Detection and Decentralized Dynamic Registry to Improve Uptake of Rheumatic Heart Disease Secondary Prevention (ADD-RHD) at Cincinnati Childrens HospitalLed by Andrea Beaton, M.D., a pediatric cardiologist at Cincinnati Childrens Hospital, this team will address the global health issue of rheumatic heart disease which affects more than 40 million people, most living in poor countries or poor areas in wealthier countries. The team will concentrate on getting more people living with rheumatic heart disease into guideline-based care using technology to find more people with rheumatic heart disease, keep them in care and generate the investment case to scale up national rheumatic heart disease action plans in low-income countries. Additionally, theyll be looking for early career doctors and scientists who want to help people get better care using technology and educate this next generation in solutions developed to improve global health in the future. The team consists of a collaborative with the Rheumatic Heart Disease Research Collaborative in Uganda (RRCU) including the Uganda Heart Institute, Childrens National Medical Center and the University of Washington in Seattle; the Cincinnati Childrens Digital Experience and Bioinformatics Centers; Northern Kentucky Universitys Biostatistics Department, Health Innovation Center and Health Sciences Institute; REACH (a global technical organization in rheumatic heart disease) and an industry partnership with Caption Health. While the project and solutions will be made for people living in developing countries, the team hopes to learn a lot about how to help people have better health in the United States.

Center for Mobile Technologies to Achieve Equity in Cardiovascular Health at The Johns Hopkins University in BaltimoreLed by cardiologist Seth Martin, M.D., M.H.S., and neurologist David Newman-Toker, M.D., Ph.D., this teams mission is to leverage mobile and wearable technologies to empower patients and clinicians, enhance the quality of care, increase value and improve the diagnosis and management of heart diseases and stroke. Early and accurate diagnoses are essential to ensure the appropriate delivery of guideline-recommended management to engage patients and their caregivers to achieve the best patient outcomes possible. The collaborative project will span the patient experience from diagnosis to management to improve patient care throughout the patient journey. Specifically, the team will develop and test a smartphone application for stroke diagnosis, following their experience with a goggle-based eye-tracking technology in the Armstrong Institute Center for Diagnostic Excellence. On the management side, the team will work on a virtual cardiovascular rehab that builds on their Corrie Health platform to empower patients in guideline-based prevention. Patients and their families from demographically diverse backgrounds will join as partners in the technology advancement process.

Center for Heart Health Technology (H2T): Innovation to Implementation at Stanford University Led by Mintu Turakhia, M.D. M.A.S., Executive Director of Stanfords Center for Digital Health, associate professor of medicine and a cardiac electrophysiologist at the VA Palo Alto Health Care System, the H2T Centers mission is to rapidly develop technologies that address unmet needs for heart health, evaluate them quickly and then implement these solutions at scale. The team will address the issue of high blood pressure, which affects more than 115 million Americans and costs the U.S. health care system more than $22 billion each year. The team will develop a clinician- and patient-facing digital health system for semi-automated management and evidence-based titration of blood pressure medications. The app will be tested in a randomized trial conducted in Northern California and New Jersey in people of different races, educations, and backgrounds and in a population of gig economy workers (rideshare drivers), who can be at increased risk of heart disease.

Wearables In Reducing Risk and Enhancing Daily Lifestyle (WIRED-L) at the University of MichiganLed by Brahmajee Nallamothu, M.D., M.P.H., a professor in the Division of Cardiovascular Diseases at the University of Michigan, this team plans to establish the Wearables In Reducing risk and Enhancing Daily Lifestyle (WIRED-L) Center dedicated to building and testing mobile health (mHealth) apps that leverage wearables like smartwatches to improve physical activity and nutrition in hypertensive patients. The apps will use just-in-time-adaptive digital interventions to deliver notifications to participants when they are most likely to be responsive using contextual information obtained from their devices. WIRED-L will enroll diverse communities that include African Americans and older adults rarely included in mHealth studies, to better close the digital divide between rich and poor. Additionally, WIRED-L will train a diverse and inclusive set of future leaders in mHealth through a highly integrated program that focuses on the key and complementary areas of clinical trials, data science, and health equity research.

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Hubert Zajicek wants to tap the strong innovation community in North Texas to share know-how, combat shortages, and come up with new solutions during the COVID-19 pandemic.

The Plano-based remote patient monitoring startup is now offering providers a no-cost solution for low-risk patients or those with mild symptoms simply by answering a series of questions.

The collaboration will allow physicians to virtually diagnose medical conditions, heightening safety for everyone.

A professor at the University of North Texas Health Science Center is collaborating with an international team to test whether stem cells can combat COVID-19 pneumonia.

Due to the effects of COVID-19, Southlake-based SmartCounseling is working to reduce costs for mental health services. The company's new platform also allows licensed professionals to expand their services online quickly.

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Health Tech: Dallas-based American Heart Association Awards $14M in Research Grants for Heart, Brain, and COVID-19 Innovation - dallasinnovates.com

Recommendation and review posted by Bethany Smith

Michelle Kuppersmith's doctor recommended a bone marrow biopsy after suspecting she had a rare blood disorder. Though the biopsy was done by an in-network provider at an in-network hospital, Kuppersmith learned she was on the hook for $2,400 for out-of-network genetic profiling. Shelby Knowles for KHN hide caption

Michelle Kuppersmith's doctor recommended a bone marrow biopsy after suspecting she had a rare blood disorder. Though the biopsy was done by an in-network provider at an in-network hospital, Kuppersmith learned she was on the hook for $2,400 for out-of-network genetic profiling.

Michelle Kuppersmith feels great, works full time and exercises three to four times a week. So she was surprised when a routine blood test found that her body was making too many platelets, which help control bleeding.

Kuppersmith's doctor suspected the 32-year-old Manhattanite had a rare blood disorder called essential thrombocythemia, which can lead to blood clots, strokes and, in rare cases, leukemia.

Her doctor suggested a bone marrow biopsy, in which a large needle is used to suck out a sample of the spongy tissue at the center of the patient's hip bone.

Doctors examine the bone marrow under a microscope and analyze the DNA. The procedure allows doctors to judge a patient's prognosis and select treatment, if needed. Kuppersmith had heard the procedure can be intensely painful, so she put it off for months.

The biopsy performed by a provider in her insurance network, at a hospital in her network lasted only a few minutes, and Kuppersmith received relatively good news.

While a genetic analysis of her bone marrow confirmed her doctor's suspicions, it showed that the only treatment she needs, for now, is a daily, low-dose aspirin. She will check in with her doctor every three to four months to make sure the disease isn't getting worse.

All in all, Kuppersmith felt relieved.

Then she got a notice saying her insurer refused to pay for the genetic analysis, leaving her responsible for a $2,400 payment.

The patient: New York resident Michelle Kuppersmith, 32, who is insured by Maryland-based CareFirst Blue Cross Blue Shield. She works as director of special projects at a Washington-based watchdog group. Because she was treated in New York, Empire Blue Cross Blue Shield which covers that region handled part of her claim.

Total amount owed: $2,400 for out-of-network genetic profiling

The providers: Kuppersmith had her bone marrow removed at the Mount Sinai Ruttenberg Treatment Center in New York City, which sent her biopsy sample to a California lab, Genoptix, for testing.

Medical services: Bone marrow biopsy and molecular profiling, which involves looking for genetic mutations

What gives: The field of molecular diagnostics, which includes a variety of gene-based testing, is undergoing explosive growth, said Gillian Hooker, president of the National Society of Genetic Counselors and vice president of clinical development for Concert Genetics, a health IT company in Nashville, Tennessee.

A report from Concert Genetics, a company that helps clients manage genetic testing, found there are more than 140,000 molecular diagnostic products on the market, with 10 to 15 added each day.

The field is growing so quickly that even doctors are struggling to develop a common vocabulary, Hooker said.

Kuppersmith underwent a type of testing known as molecular profiling, which looks for DNA biomarkers to predict whether patients will benefit from new, targeted therapies. These mutations aren't inherited; they develop over the course of a patient's life, Hooker said.

Medicare spending on molecular diagnostics more than doubled from 2016 to 2018, increasing from $493 million to $1.1 billion, according to Laboratory Economics, a lab industry newsletter.

Charges range from hundreds to thousands of dollars, depending on how many genes are involved and which billing codes insurers use, Hooker said.

Based on Medicare data, at least 1,500 independent labs perform molecular testing, along with more than 500 hospital-based labs, said Jondavid Klipp, the newsletter's publisher.

In a fast-evolving field with lots of money at stake, tests that a doctor or lab may regard as state-of-the-art an insurer might view as experimental.

Worse still, many of the commercial labs that perform the novel tests are out-of-network, as was Genoptix.

Stephanie Bywater, chief compliance officer at NeoGenomics Laboratories, which owns Genoptix, said that insurance policies governing approval have not kept up with the rapid pace of scientific advances. Kuppersmith's doctor ordered a test that has been available since 2014 and was updated in 2017, Bywater said.

Although experts agree that molecular diagnostics is an essential part of care for patients like Kuppersmith, doctors and insurance companies may not agree on which specific test is best, said Dr. Gwen Nichols, chief medical officer of the Leukemia & Lymphoma Society.

Tests "can be performed a number of different ways by a number of different laboratories who charge different amounts," Nichols said.

Insurance plans are much more likely to refuse to pay for molecular diagnostics than other lab tests. Laboratory Economics found Medicare contractors denied almost half of all molecular diagnostics claims over the past five years, compared with 5-10% of routine lab tests.

With so many insurance plans, so many new tests and so many new companies, it is difficult for a doctor to know which labs are in a patient's network and which specific tests are covered, Nichols said.

"Different providers have contracts with different diagnostic companies," which can affect a patient's out-of-pocket costs, Nichols said. "It is incredibly complex and really difficult to determine the best, least expensive path."

Kuppersmith said she has always been careful to check that her doctors accept her insurance. She made sure Mount Sinai was in her insurance network, too. But it never occurred to her that the biopsy would be sent to an outside lab or that it would undergo genetic analysis.

She added: "The looming threat of a $2,400 bill has caused me, in many ways, more anxiety than the illness ever has."

The resolution: Despite making dozens of phone calls, Kuppersmith got nothing but confusing and contradictory answers when she tried to sort out the unexpected charge.

An agent for her insurer told her that her doctor hadn't gotten preauthorization for the testing. But in an email to Kuppersmith, a Genoptix employee told her the insurance company had denied the claim because molecular profiling was viewed as experimental.

A spokesperson for New York-based Empire Blue Cross Blue Shield, which handled part of Kuppersmith's claim, said her health plan "covers medically necessary genetic testing."

New York, one of 28 states with laws against surprise billing, requires hospitals to inform patients in writing if their care may include out-of-network providers, said attorney Elisabeth Benjamin, vice president of health initiatives at the Community Service Society, which provides free help with insurance problems.

A spokesperson for Mount Sinai said the hospital complies with that law, noting that Kuppersmith was given such a document in 2018 nearly one year before her bone marrow biopsy and signed it.

Benjamin said that's not OK, explaining: "I think a one-year-old, vague form like the one she signed would not comply with the state law and certainly not the spirit of it."

Instead of sending Kuppersmith a bill, Genoptix offered to help her appeal the denied coverage to CareFirst. At first, Genoptix asked Kuppersmith to designate the company as her personal health care representative. She was uncomfortable signing over what sounded like sweeping legal rights to strangers. Instead, she wrote an email granting the company permission to negotiate on her behalf. It was sufficient.

A few days after being contacted by KHN, Kuppersmith's insurer said it would pay Genoptix at the in-network rate, covering $1,200 of the $2,400 charge. Genoptix said it has no plans to bill Kuppersmith for the other half of the charge.

The takeaway: Kuppersmith is relieved her insurer changed its mind about her bill. But, she said: "I'm a relatively young, savvy person with a college degree. There are a lot of people who don't have the time or wherewithal to do this kind of fighting."

Patients should ask their health care providers if any outside contractors will be involved in their care, including pathologists, anesthesiologists, clinical labs or radiologists, experts said. And check if those involved are in-network.

"Try your best to ask in advance," said Jack Hoadley, a research professor emeritus at Georgetown University. "Ask, 'Do I have a choice about where [a blood or tissue sample] is sent?'"

Ask, too, if the sample will undergo molecular diagnostics. Since the testing is still relatively new and expensive most insurers require patients to obtain "prior authorization," or special permission, said Dr. Debra Regier, a medical geneticist at Children's National Hospital in Washington and an associate with NORD, the National Organization of Rare Diseases. Getting this permission in advance can prevent many headaches.

Finally, be wary of signing blanket consent forms telling you that some components of your care may be out-of-network. Tell your provider that you want to be informed on a case-by-case basis when an out-of-network provider is involved and to consent to their participation.

Bill of the Month is a crowdsourced investigation by Kaiser Health News and NPR that dissects and explains medical bills. Do you have a perplexing medical bill you want to share with us? Tell us about it here.

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Bill Of The Month: Pricey Genetic Test For Essential Thrombocythemia : Shots - Health News - NPR

Recommendation and review posted by Bethany Smith

This is a very exciting era in laboratory medicine as virtually every day new genetic tests and emerging laboratory technologies enter the market. With these advancements also comes the (fun) challenge of distinguishing clinical testing from research testing. Making this distinction matters in two key ways. First, from a regulatory standpoint, it would be financially irresponsible to bill patients and insurers for research testing. Second, in terms of clinical implications, we have to demonstrate the value of classifying variants (clinical validity), then show that variant classification impacts patient clinical outcomes (clinical utility). Laboratory test stewardship programs provide an important foundation for striking an appropriate balance between implementing new genetic tests and meeting standards for clinical validity and utility, paying particular attention to the size of genetic panels.

Since the 1980s, identification of genetic markers has supported tailored clinical diagnoses and therapies, and as such, genetic testing has become an attractive diagnostic tool. Single gene testing has progressed to more expansive gene panels, exome, and even genome sequencing. While novel technologies provide the potential for increased efficiency, more comprehensive analysis, and reduced invasive testing to guide clinical care, the financial impact and potential secondary findings of these methods necessitate a balanced approach to responsibly implement precision medicine in clinical practice.

To be good laboratory testing stewards, we must address questions about the value of new and emerging technologies. Simply defined, value is the quality of a test divided by its cost. While mathematical equations are straightforward precisely because they are objective, the perspective of value varies for each stakeholder (patients, providers, laboratorians, and payers), and these perspectives often have competing interests.

A crucial consideration is the timeline in which novel technologies are implemented clinically and, perhaps even more challenging, the elements that distinguish research testing from clinical testing. Clinical testing (for all laboratory tests) encompasses analytical validity, clinical validity, and demonstrated clinical utility. In some cases, genetic tests are Food and Drug Administration (FDA)-cleared for specific clinical applications. Patients and insurers typically are responsible for the cost of clinical testing. As new assays appear on the market, they might demonstrate analytical validity, but lack evidence establishing clinical validity and utility.

Requiring patients or insurers to cover the cost of building this evidence for a new assay is contrary to laboratory stewardship principles. Lab stewards have the difficult task of distinguishing true research from ancillary testing. Advancing research and providing evidence of clinical validity and clinical utility remain critical for enhancing our overall understanding of genetic testing. One approach to balancing both needs is to find alternative funding for clinical research in order to achieve alignment with insurers while also supporting patients.

It goes without saying that strict standards for validation and documentation exist for clinical testing, and although only a minority of tests are FDA-cleared, all laboratory developed tests must adhere to CLIA regulations. This is a minimum standard; even laboratories that perform research-use only testing and return results to participants must have a CLIA license. Compliance with CLIA regulations is not the only factor in assessing a laboratorys or tests quality. Evaluating a laboratorys comprehensive services also matters, including its result reporting processes, adherence to professional society guidelines, report formatting, test billing, and sample coordination logistics.

When adopting new genetic tests, a second consideration is the size of a panel. A bigger panel with more genes or genetic markers does not necessarily improve diagnostic clarity. With an increased number of assayed genes comes greater potential for variants of uncertain significance (VUS). These variants can be particularly challenging because genomics is still relatively new and we collectively lack sufficient data to confidently classify variants as pathogenic or benign. In the absence of evidence supporting these classifications, laboratories assign variants to a VUS holding cell category. Once sufficient evidence arises, variants originally classified as VUS will be upgraded (to pathogenic or likely pathogenic) or downgraded (to benign or likely benign).

One would predict that approximately half of all VUS would be upgraded and half downgraded. However, in what is termed the VUS paradox, there is significant discordance between the expected and observed reclassification of variants. It is much more common for VUS to be reclassified as benign or likely benign (downgraded) than to be upgraded (1). Given the large body of evidence demonstrating that VUS can cause patient harm, labs act irresponsibly if they inappropriately classify variants as VUS. As laboratory stewards, we need to ensure that any gene panel ordered is the best fit for the clinical question at hand instead of using an inappropriately large gene panel likely to result in challenging VUS.

From the perspectives of patients and insurers, it is critical to demonstrate how outcomes will improve as a result of using this new technology. Are these new tests preforming better than current standard of care? In many cases, additional evidence is needed before a test is offered broadly. The following examples in cancer and prenatal settings highlight the promise of novel technologies and questions that should be considered before adopting/implementing more broadly.

Cell-free DNA screening was launched in 2012 and meta-analyses have demonstrated superior performance for detecting chromosomal aneuploidies such as Down syndrome relative to existing maternal serum screening tests like the combined and fully integrated screening tests. Since then, cell-free DNA prenatal screening has expanded rapidly, including the recent ability to detect all aneuploidies and even sub-chromosomal copy number alterations such as microdeletions and microduplications.

From a consumer perspective, cell-free DNA prenatal screening is appealingits less invasive than diagnostic testing like amniocentesis and can reveal a babys sex in the first trimester of pregnancy. However, this new modality remains a screening test and actually can complicate decision-making when used as a diagnostic test. This is because it tests both maternal and fetal cell-free DNA and uncovers findings that can be difficult to interpret.

For example, numerous cases have been reported of detecting unknown maternal cancer, which is called occult maternal malignancy. If a cell-free DNA prenatal screen identifies a potential maternal cancer, the affected patient necessarily will embark on a diagnostic hunt for a tumor during an already difficult period of pregnancy. This can be challenging from an insurers perspective as well because finding a tumor based on cell-free DNA prenatal screening results might necessitate expensive imaging studies.

While there is great promise in expanding the technology of cell-free DNA to detect single-gene Mendelian disorders, the American College of Obstetricians and Gynecologists has issued a practice advisory that, there has not been sufficient information regarding accuracy and positive and negative predictive value ... [and thus,] single-gene cell-free DNA screening is not currently recommended in pregnancy (2).

The pace at which new technology is being developed and implemented in clinical settings will undoubtedly stay in the fast lane. As such, laboratorians need to consider how to best integrate novel technologies into clinical practice (or not), striking a responsible balance between true clinical research and ancillary testing.

Using alternate funding sources for clinical research, including risk-sharing partnerships with insurers, has proven successful and may pave the way for clinical research to become true clinical testing. Practice guidelines are extremely valuable but often lag behind advances in technology precisely because they require a high burden of published evidence. An institutional approach utilizing an oversight committee, such as a laboratory stewardship committee, is an effective vehicle for evaluating implementation of new technologies and shifting appropriately from research to clinical testing when sufficient evidence exists for clinical validity and utility.

The genomic testing era is very exciting, and responsibly implementing a collaborative stewardship program is critical for ensuring that we offer the right test to the right patient at the right time.

Tina Lockwood, PhD, DABCC, DABMGG, is an associate professor in the department of laboratory medicine and director of the genetics and solid tumor diagnostics laboratory at the University of Washington in Seattle.+Email: tinalock@uw.edu

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Lab Stewardship in the Era of Genomic Testing - American Association for Clinical Chemistry (AACC)

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LOS ANGELES (CBSLA) A settlement has been reached with a Chinese genetic testing company over allegations it advertised and sold at-home COVID-19 testing kits that lacked FDA approval.

Los Angeles City Attorney Mike Feuer filed suit against Yikon Genomics, seeking a court order that directs the company to stop marketing and selling the test kits plus fines for each alleged violation. Feuer announced Monday it had reached a settlement with the company.

Yikon Genomics had touted a $39 test that promised to deliver a result in 15 minutes. The company claimed the Corona Virus At-Home Test Kit was approved by the U.S. Food and Drug Administration.

The FDA has not approved any coronavirus home test kits.

If consumers have a home test kit that hasnt been approved by the FDA, and is not likely to work properly, they might not get reliable results, and they might unknowingly expose others to this virus, Feuer said at a news conference.

Yikon Genomics, which primarily does genetic and in-vitro fertilization testing, agreed to pull its product from the market and refund anyone who purchased it.

The coronavirus outbreak and inability for most people to obtain a test has given rise to a number of coronavirus-related scams, including ones related to stimulus checks, donations, investments, inspections and fake home tests.

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LA City Attorney Settles With Chinese Genetic Company Over COVID-19 Home Test Claiming To Have FDA Approval - CBS Los Angeles

Recommendation and review posted by Bethany Smith

Dublin, April 06, 2020 (GLOBE NEWSWIRE) -- The "U.S. Hematologic Malignancies Testing Market: Focus on Product, Disease, Technology, End User, Country Data and Competitive Landscape - Analysis and Forecast, 2018-2025" report has been added to ResearchAndMarkets.com's offering.

This report projects the market to grow at a significant CAGR of 14.60% during the forecast period, 2019-2025. The U.S. hematologic malignancies market generated $723.9 million revenue in 2018, in terms of value.

The U.S. hematologic malignancies market growth has been primarily attributed to the major drivers in this market, such as rising incidence of hematologic malignancies, favorable reimbursement scenario, and increase in funding in the hematologic malignancies market. However, there are factors hindering the growth of the market, such as lack of training professionals, high pricing pressure, and issue pertaining to the analytic validity of genetic testing.

Key Questions Answered in this Report:

Market Segmentation

Key Companies in the U.S. Hematologic Malignancies Market

The key manufacturers that have been contributing significantly to the U.S. hematologic malignancies market include Abbott Laboratories, Illumina, Inc., F. Hoffmann-La Roche Ltd, Bio-Rad Laboratories, Inc., Sysmex Corporation, Cancer Genetics Inc., QIAGEN N.V., ICON plc, Quest Diagnostics Incorporated, Invitae Corporation, Opkp Health, Laboratory Corporation of American Holdings, NeoGenomics Laboratories, Inc., ASURAGEN, INC., ArcherDX, Inc., Adaptive Biotechnologies, ARUP Laboratories, and Invivoscribe, Inc, among others.

Key Topics Covered:

1 Product Definition

2 Market Scope

3 Research Methodology

4 Epidemiology of Hematological Malignancies in U.S.

5 U.S. Hematologic Malignancies Testing Market: Value and Volume Data 2019 (U.S. State Regions)5.1 Midwest U.S.5.2 Mid Atlantic5.3 The Southwest5.4 New England5.5 The West5.6 The South

6 Market Dynamics6.1 Market Drivers6.1.1 Rising Incidence of Hematologic Malignancies6.1.2 Increasing Adoption of Inorganic Growth Strategies in the Market6.1.3 Favorable Reimbursement Scenario in the U.S. hematologic Malignancies Testing Market6.1.4 Increase in Funding in Hematologic Malignancies Testing Market6.2 Restraints6.2.1 High Pricing Pressure6.2.2 Lack of Trained Professionals6.2.3 Issues Pertaining to the Analytical Validity of Genetic Testing for Cancers6.3 U.S. Market Opportunities6.3.1 An Underlying Relaxation in Revised 2018 PAMA Criteria6.3.2 Informatics and Technological Innovation for Larger Consumer Base6.3.3 Technological Advancements in the Field of Molecular Diagnostics

7 Competitive Landscape7.1 Key Strategies and Developments7.1.1 Synergistic Activities7.1.2 Approvals7.1.3 Product Launches and Enhancements7.1.4 Merger, Acquisitions & Expansions7.2 Product Scenario7.3 Funding Scenario7.4 Market Share Analysis7.5 Growth Share Analysis (Opportunity Mapping)7.5.1 By Company7.5.2 By Product

8 Industry Insights8.1 Regulatory Framework8.1.1 Legal Requirements and Framework in the U.S.8.2 Reimbursement Scenario8.2.1 Protecting Access to Medicare Act (PAMA) Criteria for Advanced Diagnostic Laboratory Tests (ADLT)8.3 Physicians' Perceptions

9 U.S. Hematologic Malignancies Testing Market (by Product) 2018-2025 ($ Million)9.1 Services9.2 Kits9.2.1 NGS-Based Gene Panels9.2.1.1 Leukemia9.2.1.2 Lymphoma9.2.1.3 Multiple Myeloma9.2.1.4 Myeloproliferative Neoplasms9.2.1.5 Myelodysplastic Syndromes9.2.2 NGS-Based Molecular Clonality Testing9.2.2.1 Leukemia9.2.2.2 Lymphoma9.2.2.3 Multiple Myeloma9.2.2.4 Myeloproliferative Neoplasms9.2.2.5 Myelodysplastic Syndromes9.2.3 NGS-Based Translocation Testing9.2.3.1 Leukemia9.2.3.2 Lymphoma9.2.3.3 Multiple Myeloma9.2.3.4 Myeloproliferative Neoplasms9.2.3.5 Myelodysplastic Syndromes9.2.4 NGS-Based Mutation Testing9.2.4.1 Leukemia9.2.4.2 Lymphoma9.2.4.3 Multiple Myeloma9.2.4.4 Myeloproliferative Neoplasms9.2.4.5 Myelodysplastic Syndromes9.2.5 NGS-Based Minimal Residual Disease (MRD) Testing9.2.5.1 Leukemia9.2.5.2 Lymphoma9.2.5.3 Multiple Myeloma9.2.5.4 Myeloproliferative Neoplasms9.2.5.5 Myelodysplastic Syndromes

10 U.S. Hematologic Malignancies Testing Market (by End User)10.1 Specialty Clinics and Hospitals10.2 Diagnostic Laboratories10.3 Reference Laboratories10.4 Research Institutions

11 U.S. Hematologic Malignancies Testing Market (by Disease)11.1 Leukemia11.2 Lymphoma11.3 Multiple Myeloma11.4 Myeloproliferative Neoplasms11.5 Myelodysplastic Syndromes

12 U.S. Hematologic Malignancies Testing Market (by Technology)12.1 Next-generation Sequencing (NGS)12.2 Polymerase Chain Reaction (PCR)12.3 Fluorescence In-Situ Hybridization (FISH)12.4 Immunohistochemistry (IHC)12.5 Flow Cytometry12.6 Other Technologies

13 Company Profiles

Story continues

Companies Mentioned

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United States Hematologic Malignancies Testing Industry (2018 to 2025) - Featuring Illumina, Invitae Corporation & Invivoscribe Among Others -...

Recommendation and review posted by Bethany Smith

Unlike some countries, we didnt go into this crisis with a huge diagnostics industry. We have the best scientific labs in the world, but we did not have the scale, Matt Hancock said this week, facing a barrage of questions on why the UK is lagging behind others on coronavirus testing.

The UKs health secretary said his German counterpart could call on 100 test labs and rely on the heavy presence of Roche, one of the worlds largest diagnostics companies, to achieve its current level of more than 50,000 tests a day. The UK had had to build from a lower base, he said.

Industry players say this is a fair characterisation. We have a lot of diagnostics capability in this country but what we dont have is the global diagnostics giants, said Tony Cooke of Cambridge Clinical Laboratories. Even when we have our own companies, a lot of the supplies are coming from the US or Germany.

The UK is not alone in struggling to meet demand. France has carried out even fewer tests than the UK, and Spain tried to bridge supply chain issues by buying millions of test kits from China that later had to be withdrawn after giving flawed results.

As well as Roche, which has developed a single machine that can churn out 1,000 test results a day, Germany also has Qiagen, a major supplier of genetic testing kits, which are being used to diagnose Covid-19. Both companies also produce reagents and components used in kits put together by other manufacturers. The US has called on Abbott, Thermofisher, Quest Diagnostics and Hologic.

The more distributed hospital lab system in countries such as Germany and Italy has also served them well in being able to increase testing for Covid-19. The NHS has spent years centralising its testing labs, which under normal circumstances was both economical and clinically robust. It has allowed labs to be aligned to standard diagnostic criteria and to use the same test kits, reagents and equipment from the same suppliers, allowing bulk purchases from single suppliers at a competitive price.

During a pandemic, however, this dependency on a handful of non-domestic suppliers, such as Roche, for kits and reagents becomes a fundamental flaw.

Allan Wilson, the president of the Institute of Biomedical Science, says the UK could have done a better job of surveying its diagnostic landscape and built a strategy around existing strengths, which include having a large number of research labs and smaller, but highly innovative diagnostics companies.

The re-engineering of HIV testing machines into 90-minute Covid-19 tests by Diagnostics for the Real World in Cambridge, which within a week will meet the entire testing requirements of Addenbrookes hospital in the city, is an example of the type of approach that could have been encouraged nationally.

We were slow to make that decision in testing and we approached it in too narrow a perspective, said Wilson. Were doing it regional locally, people forming and forging partnership arrangements, looking for support from universities and commercial companies.

Industry figures say that more could be done in future to nurture some of these startups and medium-sized companies into home-grown giants.

There is a record to show that innovative businesses started in the UK have this potential, but that beyond a certain level of success the companies tend to migrate to the US where venture capital and buyers are in more ready supply.

Medisense, which was spun out of Oxford University in the 1990s, revolutionised the blood glucose sensing industry in the 1990s, then was acquired by the US company Abbott. Solexa, a genetic sequencing company spun out of Cambridge, was acquired by Illumina in the US for about $650m in 2007 and is now worth about $40bn.

Gordon Sanghera, the chief executive of the sequencing and diagnostics company Oxford Nanopore, whose technology was used to characterise the very first example of the coronavirus in Wuhan, said Hancocks acknowledgement of the need to nurture a domestic industry was welcome and should not be forgotten after the crisis has passed.

Hancocks declaration that the UK needs a new diagnostic industry is right, and we have plenty of seeds, he said. Its the collaboration with the broader scientific community, and looking at access to capital for UK companies, that will make those seeds grow and bear fruit that helps people not only in the UK, but all around the world.

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Why has the UK lagged behind in testing for the coronavirus? - The Guardian

Recommendation and review posted by Bethany Smith

Apr 2nd 2020

Editors note: The Economist is making some of its most important coverage of the covid-19 pandemic freely available to readers of The Economist Today, our daily newsletter. To receive it, register here. For more coverage, see our coronavirus hub

WHEN A NEW virus invades the human body, the immune system leaps into action. First to the scene are antibody molecules of a type called immunoglobulin M (IgM). These bind with proteins on a viruss surface, disabling it and marking it for destruction by cells called macrophages. A few days later the system produces a second type of antibody, immunoglobulin G (IgG), to continue the fight. IgMs are short-lived. They stick around in the bloodstream for three or four weeks before disappearing. IgGs, however, are the basis for a much longer-term form of immunity. This can last for many years, or even a lifetime.

Kits that test for these two types of antibodies when they have been raised specifically by SARS-CoV-2 should soon become available. The virus causing the covid-19 is already being detected with genetic tests, which look directly for current signs of infection in nasal or throat swabs. Tests to detect antibodies will also be able to identify those who have had infections in the past and may now be immune. In the short term, this will be important because it will permit the authorities to identify who may return to their jobs without risk of infecting others. That is particularly valuable in the cases of doctors, nurses and the numerous other health-care workers needed to look after those who are seriously ill. It will also help in the longer run, by revealing how far the virus has spread through a population, and thus whether or not herd immunity is likely to have built up. Herd immunity is the point where insufficient infectible individuals remain in a population for a virus to be able to find new hosts easily, and it is therefore safe to lift social-distancing and stay-at-home rules.

SARS-CoV-2 antibody tests have already been deployed in limited numbers in China, Singapore and South Korea. Several Western governments, including those of America and Britain, have been buying up millions of surplus antibody tests from China for use in their own countries. Several other types of these tests have also been developed by companies around the world. None, however, has yet been approved for widespread usefor, though such tests are reasonably easy to manufacture, ensuring that they give useful and reliable results is taking a lot of effort.

Each different design of test uses its own recipe of chemicals and processes. Physically, however, many resemble the self-contained plastic sticks employed in the version made by Biopanda Reagents, a British firm. A user first pricks a fingertip. Then he or she introduces a few drops of blood into an opening at one end of the stick. Inside, the blood goes through a series of chemical processes that can identify particular antibodies. It takes around 15 minutes to get a result, and this is displayed in a similar fashion to that used by a typical pregnancy testthe positive identification of an antibody resulting in a coloured line next to its label on the test stick.

There are three interesting signals. A solitary positive for IgM means the person has had a very recent (potentially current) infection. Positives for both IgM and IgG mean the user was infected some time within the past month. A positive for IgG alone means that the infection occurred more than a month ago, and the user should now be immune to a repeat of it. (A negative result probably means no infection, though it could also mean that it is too early in the course of an infection for antibodies to have appeared, since the first IgMs typically turn up only 7-10 days after an infection has begun.)

Before regulators can approve a test for widespread use, they need to validate it. How useful it is can be summarised by two numbers determined during this validation: its sensitivity and its specificity.

A tests sensitivity refers to how good it is at detecting the thing it is meant to detectin this case the IgM and IgG antibodies associated with SARS-CoV-2. A sensitivity of 95% means that, from 100 blood samples known (by other means, such as previous genetic testing) to be infected, the test will reliably tag 95 correctly as having the pertinent antibodies. The remaining five would be identified as having no antibodies presentin other words they would be false negatives.

The other significant number, a tests specificity, measures how good that test is at detecting only the antibodies it is meant to detect. There are seven human coronaviruses and, ideally, a test would detect only antibodies produced in response to SARS-CoV-2. A test with 98% specificity means that, of 100 known uninfected blood samples, 98 will come back (correctly) as negative and the final two will come back (falsely) as positive. Such false positives could have many causes. A common one is cross-reaction, in which a test responds to the wrong antibodies.

To work out a tests sensitivity and specificity, it needs to be checked against hundreds of samples of known status. Given the novelty of SARS-CoV-2, and therefore the lack of easy access to relevant blood samples, this takes time. The British and American authorities are assessing several tests, but have released no validation data as yet, and have been tight-lipped about when they will do so.

An ideal test would be 100% sensitive and 100% specific. In reality, there will always be a trade-off between the two. Make a test acutely sensitive, so that it gives a positive signal with even the tiniest amounts of a relevant antibody present, and it will get less specific. This is because such a fine chemical hair-trigger is likely to be set off by antibodies similar to, but not identical with the target. And vice versa.

This trade-off is not always a bad thing, for it allows different sorts of test to be used in different circumstances. For example, if the intention of testing is to identify doctors and nurses who have antibodies to SARS-CoV-2, so that they can safely return to work with infected patients, because they are themselves now immune to infection, then the most important thing is for a test to have a low rate of false positives. In other words, it needs a high specificity.

By contrast, if the idea is to gather transmission data, sensitivity is the priority. If someone were identified as having had an infection, further tests could trace which of that persons acquaintances were also infected, or had once been infected and were now immune. In these circumstances, a few false positives would not be a disaster. They would probably show up eventually, because those around the allegedly infected individual would not be infected as often as expected. A false negative, though, would mean lost information and a consequent lack of contact-tracing. That would be significant.

Testing of this sort will let doctors understand how a local cluster of infections grows, and therefore what action to take in order to break the chain (meaning, in practice, who needs to be quarantined). This kind of contact-tracing and isolation has been employed to great effect in South Korea through the use of genetic tests for the virus. Antibody tests will enhance the process, by capturing data on those infected in the past as well as the present.

Children are another group who could profitably be monitored using antibody tests. It is now well established that they are less likely than adults to present the symptoms of covid-19, and rarely suffer severe disease. It remains unclear, though, to what degree they are being infected silently, and are thus able to pass the infection on to others around them while apparently remaining healthy themselves. Antibody tests will reveal a fuller picture.

Antibody tests will no doubt also be in demand from members of the public wanting to know their immune statusfor their peace of mind if nothing else. This might be cause for conflict. Even when they are cleared for general use it will take time for manufacturers to ramp up the production of tests, and those working in health care and one or two other important areas, like teaching, policing and delivering groceries to stores and markets, will surely be at the head of the queue to be tested. It is therefore hardly surprising that unvalidated kits, purportedly for domestic use, are already being offered for sale by unscrupulous online suppliers. Britains medical regulator, for one, has had to take down several fraudulent websites and is warning people not to use any home-testing kits they find being sold online.

Even when more kits do become available (and with due acknowledgment to the different putative uses of different sorts of test) the next goal for most countries after protecting crucial members of the workforce will be population-level surveillance. This will, as a by-product, provide information to individual members of the public. But its primary purpose will be to track how the epidemic is progressing.

One of the most important elements of this analysis will be determining the rate of silent infectionwith all the implications that brings for herd immunity. Comparing recent test data from the Netherlands and Iceland hints at the gap in current knowledge of just how much silent infection there may be. Both countries use genetic testing for the virus, but the Netherlands only tests those with severe symptoms of covid-19, whereas Iceland has been testing widely, even people without symptoms. Unsurprisingly, but crucially, the Icelandic approach has revealed far more infections in younger people than the Dutch one (see chart). Moreover, according to Kari Stefansson, who is leading the Icelandic project, 50% of those who have tested positive reported no symptoms.

Mass testing will be laborious. It will mean taking regular blood samples from millions of people, even though the actual analysis will be done by robots in centralised high-throughput laboratories. To save effort, such projects might piggyback on a countrys blood-transfusion services, for donated blood is already subject to rigorous screening for pathogens.

German scientists have announced plans to start, this month, a reasonably large-scale surveillance project. It will monitor blood samples taken regularly from 100,000 participants. Those proving immune may be given a certificate exempting them from restrictions on working or travelling. If nothing else, that would certainly be an incentive to sign up.

Dig deeper:

For our latest coverage of the covid-19 pandemic, register for The Economist Today, our daily newsletter, or visit our coronavirus hub

This article appeared in the Science and technology section of the print edition under the headline "Testings testimony"

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An antibody test for the novel coronavirus will soon be available - The Economist

Recommendation and review posted by Bethany Smith

Fulgent Genetics, Inc.s (NASDAQ:FLGT): Fulgent Genetics, Inc., together with its subsidiaries, provides genetic testing services to physicians with clinically actionable diagnostic information. The US$206m market-cap company announced a latest loss of -US$411.0k on 31 December 2019 for its most recent financial year result. As path to profitability is the topic on FLGTs investors mind, Ive decided to gauge market sentiment. In this article, I will touch on the expectations for FLGTs growth and when analysts expect the company to become profitable.

See our latest analysis for Fulgent Genetics

According to the 2 industry analysts covering FLGT, the consensus is breakeven is near. They expect the company to post a final loss in 2020, before turning a profit of US$3.4m in 2021. FLGT is therefore projected to breakeven around a couple of months from now! In order to meet this breakeven date, I calculated the rate at which FLGT must grow year-on-year. It turns out an average annual growth rate of 147% is expected, which is extremely buoyant. If this rate turns out to be too aggressive, FLGT may become profitable much later than analysts predict.

Underlying developments driving FLGTs growth isnt the focus of this broad overview, however, bear in mind that generally a high forecast growth rate is not unusual for a company that is currently undergoing an investment period.

One thing Id like to point out is that FLGT has no debt on its balance sheet, which is quite unusual for a cash-burning loss-making, growth company, which typically has high debt relative to its equity. This means that FLGT has been operating purely on its equity investment and has no debt burden. This aspect reduces the risk around investing in the loss-making company.

This article is not intended to be a comprehensive analysis on FLGT, so if you are interested in understanding the company at a deeper level, take a look at FLGTs company page on Simply Wall St. Ive also put together a list of relevant aspects you should further research:

If you spot an error that warrants correction, please contact the editor at editorial-team@simplywallst.com. This article by Simply Wall St is general in nature. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. Simply Wall St has no position in the stocks mentioned.

We aim to bring you long-term focused research analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Thank you for reading.

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When Will Fulgent Genetics, Inc. (NASDAQ:FLGT) Breakeven? - Simply Wall St

Recommendation and review posted by Bethany Smith

ELMWOOD PARK, N.J., April 6, 2020 /PRNewswire/ -- BioReference Laboratories, Inc., an OPKO Health company (NASDAQ: OPK), today announced that it will continue to prioritize COVID-19 testing for hospital inpatients and critically ill patients around the country.

"Our goal is to maintain the current 24 hour turnaround time for these patients," said Jon R. Cohen, M.D., Executive Chairman of BioReference Laboratories. "Nothing is more important than getting a timely result back to the medical personnel on the front lines making treatment decisions on a minute-to-minute basis."

"Multiple types of hospitals, for-profit, not-for-profit, large health systems, individual hospitals, academic medical centers, and community hospitals have all reached out to get their results in a timely fashion. We have now tested almost 200,000 patients and will continue to grow our capacity from 20,000 tests/day to 35,000 tests/day within the next week.While prioritizing hospital patients, at the same time we will continue to strive to keep our current turnaround time for non-hospital patients at 2-3 days from the time we receive the specimen," said Dr. Cohen.

Providers should refer to the most current CDC guidelines for further information on appropriate testing of patients, available here https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-criteria.html.

About COVID-19 Testing at BioReference Laboratories, Inc.BioReference Laboratories is accepting specimens for COVID-19 testing from healthcare providers, clinics and health systems throughout the United States to promote earlier diagnosis of the coronavirus and to aid in limiting spread of infection. In addition to its nationwide COVID-19 testing offering, BioReference has partnerships with the New York State Department of Health, the New York City Health and Hospital Corporation (NYC Health + Hospitals), the State of New Jersey, the State of Florida and the cities of Detroit and Miami to provide COVID-19 testing.

BioReference is offering a real-time reverse-transcription polymerase chain reaction (real-time RT-PCR) assay with expected 24-72 hour turnaround time. The Novel Coronavirus COVID-19 test has been made available pursuant to the U.S. Food and Drug Administration Emergency Use Authorization for diagnostic testing in CLIA certified high-complexity laboratories. All tests are conducted in BioReference's main laboratory in Elmwood Park, N.J., which currently has a capacity to run up to 20,000 COVID-19 tests per day. For more information, visithttps://www.bioreference.com/coronavirus.

About BioReference Laboratories, Inc.BioReference provides comprehensive testing to physicians, clinics, hospitals, employers, government units, correctional institutions and medical groups. The company is in network with the five largest health plans in the United States, operates a network of 10 laboratory locations, and is backed by a medical staff of more than 160 MD, PhD and other professional level clinicians and scientists. For more information, visitwww.bioreference.com.

About OPKO HealthOPKO Health is a diversified healthcare company. In diagnostics, its BioReference Laboratories is one of the nation's largest full-service clinical laboratories; GeneDx is a rapidly growing genetic testing business; the 4Kscore test is used to assess a patient's individual risk for aggressive prostate cancer following an elevated PSA and to help decide about next steps such as prostate biopsy; Claros 1 is a point-of-care diagnostics platform with a total PSA test approved by the FDA. In our pharmaceutical pipeline, RAYALDEE is our first pharmaceutical product to be marketed. OPK88003, a once-weekly oxyntomodulin for type 2 diabetes and obesity - reported positive data from a Phase 2 clinical trial. It's among a new class of GLP-1/glucagon receptor dual agonists. OPK88004, a SARM (selective androgen receptor modulator) is currently being studied for various potential indications. The Company's most advanced product utilizing its CTP technology, a once-weekly human growth hormone for injection, successfully met its primary endpoint and key secondary endpoints in a Phase 3 study and is partnered with Pfizer. OPKO also has research, development, production and distribution facilities abroad.

Cautionary Statement Regarding Forward-Looking StatementsThis press release contains "forward-looking statements," as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "intends," "estimates," and other words of similar meaning, including statements regarding BioReference's testing for COVID-19 and the timing of and availability of the test, the expected daily capacity for testing, the ability to expand our test capacity and the timeline for doing so, and the expected turnaround time for testing of hospital and non-hospital patients, as well as other non-historical statements about our expectations, beliefs or intentions regarding our business, technologies and products, financial condition, strategies or prospects. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. These factors include those described in the OPKO Health, Inc. Annual Reports on Form 10-K filed and to be filed with the Securities and Exchange Commission and in its other filings with the Securities and Exchange Commission. In addition, forward-looking statements may also be adversely affected by equipment and reagent shortages, general market factors, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new products and indications, manufacturing issues that may arise, patent positions and litigation, among other factors. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA

Originally posted here:
OPKO Health's BioReference Laboratories Partners with Hospitals Nationwide to Provide Prioritized Testing to Inpatients with Suspected Coronavirus...

Recommendation and review posted by Bethany Smith

The answer to South Africas need for a Covid-19 testing kit which is both portable and fast may, in time, lie in the hands of Japans Canon Medical Systems Corporation (CMSC).

Also read: Covid-19: SA not manufacturing rapid test kits Department of Health is looking at a number of options

The company has partnered with Nagasaki University, Japan, to develop the Genelyzer Kit to test for SARS-CoV-2, a testing system which takes under 40 minutes from the time a specimen is collected from a patient to the delivery of results.

In cases where the test has been positive for SARS-CoV-2, it can detect 15 or more viral genome copies with 100 percent sensitivity.

This testing system makes it possible to quickly detect a novel coronavirus gene in patient specimens and, aside from being quick to administer, boasts a light weight, compact design which makes it ideal for a wide range of testing situations, including remote clinical sites.

Also read: Covid-19: WHO announces new recommendations for hand hygiene

The kit, which was validated by the Ministry of Health, Labour and Welfare and the National Institute of Infectious Diseases of Japan on March 26, consists of a set of reagents for SARS-CoV-2 RNA testing using a gene amplification technique known as the fluorescent loop-mediated isothermal amplification (LAMP) method.

Based on the clinical tests, the rapid genetic testing system has been granted approval for practical application in government-conducted testing within Japan.

In order to take full advantage of the testing systems rapid testing capabilities, we will continue evaluating its practical application in public health protection and border control measures at clinical sites, airports, and other locations where testing needs to be completed on the same day.

Canon Medical Systems Corporation hopes that the testing system will be used at a wide range of clinical sites in Japan to help control the spread of Covid-19.

At the same time, our goal is to contribute to the development of effective measures against the spread of infectious diseases in all parts of the world using this rapid genetic testing system, says Canon Medical Systems Corporation president and CEO Toshio Takiguchi.

Dear reader,

As your local news provider, we have the duty of keeping you factually informed on Covid-19 developments.

As you may have noticed, mis- and disinformation (also known as fake news) is circulating online. Caxton Local Media is determined to filter through the masses of information doing the rounds and to separate truth from untruth in order to keep you adequately informed

Local newsrooms follow a strict pre-publication fact-checking protocol.

A national task team has been established to assist in bringing you credible news reports on Covid-19.

Readers with any comments or queries may contact National Group Editor Irma Green ([emailprotected]) or Legal Adviser Helene Eloff ([emailprotected])

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Covid-19: The answer to rapid test results may be within reach - Bedfordview & Edenvale News

Recommendation and review posted by Bethany Smith