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Raiders Of The Lost Crops: Scientists Race Against Time To Save Genetic Diversity – NPR

Members of the Crop Wild Relatives project from the Crop Trust joined their research partners in Nepal on an expedition to collect wild relatives of rice, okra and eggplant in October 2017. Hannes Dempewolf of the Crop Trust says the elephants kept the researchers high enough off the ground that they didn't have to worry about any snakes that might be lurking. L.M. Salazar/Crop Trust hide caption

Members of the Crop Wild Relatives project from the Crop Trust joined their research partners in Nepal on an expedition to collect wild relatives of rice, okra and eggplant in October 2017. Hannes Dempewolf of the Crop Trust says the elephants kept the researchers high enough off the ground that they didn't have to worry about any snakes that might be lurking.

Call it a tale of science and derring-do. An international team of researchers has spent six years fanning across the globe, gathering thousands of samples of wild relatives of crops. Their goal: to preserve genetic diversity that could help key crops survive in the face of climate change. At times, the work put these scientists in some pretty extreme situations.

Just ask Hannes Dempewolf. Two years ago, the plant geneticist found himself in a rainforest in Nepal, at the foot of the Himalayas. He was riding on the back of an elephant to avoid snakes on the ground and to scare away any tigers that might be lurking about. Then all of a sudden came an attack from above.

"There were leeches dropping on us from all directions," Dempewolf recalls "bloodsucking leeches."

Now, this is far from where he thought he'd be when he got his Ph.D. But as a senior scientist and head of global initiatives at the Crop Trust, Dempewolf has been overseeing an ambitious international collaboration. More than 100 scientists in 25 countries have been venturing out to collect wild relatives of domesticated crops like lentils, potatoes, chickpeas and rice that people rely on around the world. The Crop Trust has just released a report detailing the results of this massive effort, which secured more than 4,600 seed samples of 371 wild relatives of key domesticated crops that the world relies on.

The "collecting teams are heading out into wild places and hard-to-reach corners within their countries to try to find and track down some of these wild species that have either never been collected before or are very underrepresented in seed banks," Dempewolf explains. So he says it's not surprising that many of the stories coming out of the project have an Indiana Jones-like sense of adventure to them.

Take, for example, an effort to collect Oryza glumaepatula, a wild rice species found in Latin America. Griselda Arrieta Espinoza, a crop genetics and biotechnology researcher at the University of Costa Rica, was part of a collecting team that set out to northern Costa Rica to collect a particular population of this wild rice that grows in a river. "Collecting it was quite the adventure," she tells me in Spanish because the river is also home to crocodiles.

While the effort was dangerous, Arrieta says it was also worth it, because Oryza glumaepatula is known to be resistant to a fungus that attacks domesticated rice grown around the world. And she notes that researchers in Brazil have already managed to cross Oryza glumaepatula with domesticated rice to improve crop yields.

Jamal Mabrouki, a technician with the International Center for Agricultural Research in the Dry Areas, works on a grasspea breeding project at ICARDA's facilities at Marchouch station, Morocco. Michael Major/Crop Trust hide caption

Jamal Mabrouki, a technician with the International Center for Agricultural Research in the Dry Areas, works on a grasspea breeding project at ICARDA's facilities at Marchouch station, Morocco.

The overall goal of the Crop Trust project is to make sure that this kind of valuable genetic diversity is preserved in seed banks before wild crop relatives disappear as urban development encroaches on once wild habitats. Dempewolf says that this is already happening.

"Some of the populations that the [research teams] were hoping to collect, when they reached the areas where they had seen populations before, they had disappeared," Dempewolf says.

Steven Tanksley, a professor emeritus of plant breeding at Cornell University, who was not involved in the Crop Trust project, praised the effort. He notes that the domesticated crops we eat today were selected from wild plants over thousands of years. He says this "natural reservoir of diversity ... has allowed plant breeding to attempt to keep pace with the demands of the growing human population."

That diversity took shape over millions of years, molded by natural selection, so "when you lose it, you really can't repeat that process," says Tanksley, who is also chief technology officer for Nature Source Improved Plants, which focuses on the genetic improvement of plants.

In the past, he notes, breeders have used wild crop relatives to improve disease resistance in many domesticated crops, including tomatoes, potatoes, rice and wheat.

A growing global population and changing environmental conditions because of climate change present urgent new challenges for crop breeders, Tanksley says.

"If we're going to have a sustainable world with a sustainable environment, we have to produce a lot more food per hectare than we ever have in the past," he says, adding, "I think people don't really grasp that the urgency of it."

And without the genetic diversity of wild crop relatives, he says, the world will have little chance of keeping up with growing demand for food.

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Raiders Of The Lost Crops: Scientists Race Against Time To Save Genetic Diversity - NPR

Kim Kardashian West’s battle with psoriatic arthritis: Will understanding the genetics of the autoimmune disorder point to a cure? – Genetic Literacy…

In September, the world of entertainment news buzzed with word that Kim Kardashian West tested positive for lupus and rheumatoid arthritis. The star underwent further tests, however, resulting in a diagnosis of psoriatic arthritis instead. While all three autoimmune disorders share some signs and symptoms, psoriatic arthritis is generally considered to have a better prognosis than lupus. That said, the conditions can co-exist and lupus has gotten a reputation for being difficult to diagnose, especially in the absence of the butterfly-shaped rash on ones cheeks and nose.

Im so relieved. The pain is going to come and go sometimes, but I can manage it and this is not going to stop me, Kardashian said in an article in response to receiving her psoriatic arthritis diagnosis. Her relief at not having lupus is understandable, given that lupus can affect a greater number of organs and systems in the body and is considered to be life-threatening.

Lupus, rheumatoid arthritis and psoriatic arthritis are examples of some conditions that are often considered when an individual is undergoing diagnosis for certain autoimmune diseases, because they share several symptoms and can trigger positive results in the same diagnostic tests. Kim Kardashian received the initial news that she had lupus or rheumatoid arthritis likely due to positive antinuclear antibody (ANA) test results.

An ANA is a blood test ordered when a doctor, usually a rheumatologist, suspects that a patient has a particular kind of autoimmune disorder. This test checks for the existence of autoantibodies, which are produced when a persons body is, in effect, attacking itself and several areas of the body are affected. A positive ANA test usually indicates that the doctors suspicions are confirmed, and then other factors (like medical and family history) need to be considered and more tests done to arrive at a diagnosis.

Psoriatic arthritis is usually diagnosed between the ages of 20 and 50, and occurs in women and men equally. While there is no cure, appropriate and early treatment can help prevent major damage to affected parts of the body.

Psoriatic arthritis appears in a minority of individuals who have already been diagnosed with psoriasis, an autoimmune skin condition with which Kim Kardashian and her mother, Kris Jenner, had already been diagnosed. Psoriatic arthritis affects around 520,000 individuals in the United States alone.

The autoimmune condition is believed to be caused by a combination of genetic factors and environmental triggers. So while some people inherit psoriatic arthritis-related genes, only a subset of those individuals will go on to develop the condition. In these cases, the disease could be triggered by other illnesses or infections, various forms of extreme stress, poor diet, smoking, and so on.

Around 40 percent of psoriatic arthritis patients have one or more close family members with psoriasis or psoriatic arthritis diagnosis, which strongly indicates that the disease is hereditary. Interestingly, recent research has suggested that psoriasis patients who go on to develop psoriatic arthritis have a different genetic profile than those who do not. And the most well-studied of the psoriatic arthritis genes belong to a family of genes called the human leukocyte antigen (HLA) complex, which help the body tell the difference between its own proteins and viral or bacterial proteins.

According to Genetics Home Reference by the U.S. National Library of Medicine, Variations of several HLA genes seem to affect the risk of developing psoriatic arthritis, as well as the type, severity, and progression of the condition.

Ive been feeling so tired, so nauseous, and my hands are really getting swollen. I feel like I literally am falling apart. My hands are numb, Kardashian said on a recent episode of Keeping Up with the Kardashians.

These kinds of descriptions are common in all three conditions lupus, rheumatoid arthritis, and psoriatic arthritis though each patient presents with a different array of symptoms, and all with varying degrees of severity. The main symptoms of psoriatic arthritis are pain, stiffness, and swelling in affected joints, along with chronic fatigue. Joints near the end of the fingertips and tips of the toes are often affected, as are bones in the spine.

The symptoms of psoriatic arthritis tend to worsen over time, though some patients experience periods of remission when symptoms temporarily improve. Compared to rheumatoid arthritis, psoriatic arthritis is more likely to cause swelling in the smallest joints of the fingers and toes, foot pain (in the heel and/or sole of the foot), and lower back pain caused by inflammation in vertebral joints. Patients with psoriatic arthritis are also more likely to experience symptoms on one side of the body or in different appendages on each side (in other words, it tends to be an asymmetric disease), whereas patients with rheumatoid arthritis are more likely to experience symptoms that affect both sides of the body equally (symmetric disease).

Most if not all patients with psoriatic arthritis also have psoriasis, an autoimmune condition that causes red, scaly patches of skin that can be itchy, painful and embarrassing. Psoriasis usually precedes the onset of psoriatic arthritis by several years. People with psoriatic arthritis commonly experience fingernail changes, too, such as the formation of a pitted or ridged nail surface, or the nails become separated from the nail beds.

There are several treatment options for psoriatic arthritis, which include nonsteroidal anti-inflammatory drugs (NSAIDs) to reduce inflammation and pain, immunosuppressants to suppress the immune system, disease-modifying antirheumatic drugs (DMARDs) to slow the progression of the disease, and newer medications that minimize the activity of certain enzymes involved in the inflammatory process. Treatment plans may also involve steroid injections administered directly into affected joints, or joint replacement surgery in cases where the disease has significantly progressed.

Kristen Hovet covers genetics, medical innovations and the intersection of sociology and culture. The North Dakota native is based in Vancouver, Canada, where she is working on a masters degree in health communication at Washington State University. Follow her on her website or Twitter @kristenhovet

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Kim Kardashian West's battle with psoriatic arthritis: Will understanding the genetics of the autoimmune disorder point to a cure? - Genetic Literacy...

China Uses DNA to Map Faces, With Help From the West – The New York Times

TUMXUK, China In a dusty city in the Xinjiang region on Chinas western frontier, the authorities are testing the rules of science.

With a million or more ethnic Uighurs and others from predominantly Muslim minority groups swept up in detentions across Xinjiang, officials in Tumxuk have gathered blood samples from hundreds of Uighurs part of a mass DNA collection effort dogged by questions about consent and how the data will be used.

In Tumxuk, at least, there is a partial answer: Chinese scientists are trying to find a way to use a DNA sample to create an image of a persons face.

The technology, which is also being developed in the United States and elsewhere, is in the early stages of development and can produce rough pictures good enough only to narrow a manhunt or perhaps eliminate suspects. But given the crackdown in Xinjiang, experts on ethics in science worry that China is building a tool that could be used to justify and intensify racial profiling and other state discrimination against Uighurs.

In the long term, experts say, it may even be possible for the Communist government to feed images produced from a DNA sample into the mass surveillance and facial recognition systems that it is building, tightening its grip on society by improving its ability to track dissidents and protesters as well as criminals.

Some of this research is taking place in labs run by Chinas Ministry of Public Security, and at least two Chinese scientists working with the ministry on the technology have received funding from respected institutions in Europe. International scientific journals have published their findings without examining the origin of the DNA used in the studies or vetting the ethical questions raised by collecting such samples in Xinjiang.

In papers, the Chinese scientists said they followed norms set by international associations of scientists, which would require that the men in Tumxuk (pronounced TUM-shook) gave their blood willingly. But in Xinjiang, many people have no choice. The government collects samples under the veneer of a mandatory health checkup program, according to Uighurs who have fled the country. Those placed in internment camps two of which are in Tumxuk also have little choice.

The police prevented reporters from The New York Times from interviewing Tumxuk residents, making verifying consent impossible. Many residents had vanished in any case. On the road to one of the internment camps, an entire neighborhood had been bulldozed into rubble.

Growing numbers of scientists and human rights activists say the Chinese government is exploiting the openness of the international scientific community to harness research into the human genome for questionable purposes.

Already, China is exploring using facial recognition technology to sort people by ethnicity. It is also researching how to use DNA to tell if a person is a Uighur. Research on the genetics behind the faces of Tumxuks men could help bridge the two.

The Chinese government is building essentially technologies used for hunting people, said Mark Munsterhjelm, an assistant professor at the University of Windsor in Ontario who tracks Chinese interest in the technology.

In the world of science, Dr. Munsterhjelm said, theres a kind of culture of complacency that has now given way to complicity.

Sketching someones face based solely on a DNA sample sounds like science fiction. It isnt.

The process is called DNA phenotyping. Scientists use it to analyze genes for traits like skin color, eye color and ancestry. A handful of companies and scientists are trying to perfect the science to create facial images sharp and accurate enough to identify criminals and victims.

The Maryland police used it last year to identify a murder victim. In 2015, the police in North Carolina arrested a man on two counts of murder after crime-scene DNA indicated the killer had fair skin, brown or hazel eyes, dark hair, and little evidence of freckling. The man pleaded guilty.

Despite such examples, experts widely question phenotypings effectiveness. Currently, it often produces facial images that are too smooth or indistinct to look like the face being replicated. DNA cannot indicate other factors that determine how people look, such as age or weight. DNA can reveal gender and ancestry, but the technology can be hit or miss when it comes to generating an image as specific as a face.

Phenotyping also raises ethical issues, said Pilar Ossorio, a professor of law and bioethics at the University of Wisconsin-Madison. The police could use it to round up large numbers of people who resemble a suspect, or use it to target ethnic groups. And the technology raises fundamental issues of consent from those who never wanted to be in a database to begin with.

What the Chinese government is doing should be a warning to everybody who kind of goes along happily thinking, How could anyone be worried about these technologies? Dr. Ossorio said.

With the ability to reconstruct faces, the Chinese police would have yet another genetic tool for social control. The authorities have already gathered millions of DNA samples in Xinjiang. They have also collected data from the hundreds of thousands of Uighurs and members of other minority groups locked up in detention camps in Xinjiang as part of a campaign to stop terrorism. Chinese officials have depicted the camps as benign facilities that offer vocational training, though documents describe prisonlike conditions, while testimonies from many who have been inside cite overcrowding and torture.

Even beyond the Uighurs, China has the worlds largest DNA database, with more than 80 million profiles as of July, according to Chinese news reports.

If I were to find DNA at a crime scene, the first thing I would do is to find a match in the 80 million data set, said Peter Claes, an imaging specialist at the Catholic University of Leuven in Belgium, who has studied DNA-based facial reconstruction for a decade. But what do you do if you dont find a match?

Though the technology is far from accurate, he said, DNA phenotyping can bring a solution.

To unlock the genetic mysteries behind the human face, the police in China turned to Chinese scientists with connections to leading institutions in Europe.

One of them was Tang Kun, a specialist in human genetic diversity at the Shanghai-based Partner Institute for Computational Biology, which was founded in part by the Max Planck Society, a top research group in Germany.

The German organization also provided $22,000 a year in funding to Dr. Tang because he conducted research at an institute affiliated with it, said Christina Beck, a spokeswoman for the Max Planck Society. Dr. Tang said the grant had run out before he began working with the police, according to Dr. Beck.

Another expert involved in the research was Liu Fan, a professor at the Beijing Institute of Genomics who is also an adjunct assistant professor at Erasmus University Medical Center in the Netherlands.

Both were named as authors of a 2018 study on Uighur faces in the journal Hereditas (Beijing), published by the government-backed Chinese Academy of Sciences. They were also listed as authors of a study examining DNA samples taken last year from 612 Uighurs in Tumxuk that appeared in April in Human Genetics, a journal published by Springer Nature, which also publishes the influential journal Nature.

Both papers named numerous other authors, including Li Caixia, chief forensic scientist at the Ministry of Public Security.

In an interview, Dr. Tang said he did not know why he was named as an author of the April paper, though he said it might have been because his graduate students worked on it. He said he had ended his affiliation with the Chinese police in 2017 because he felt their biological samples and research were subpar.

To be frank, you overestimate how genius the Chinese police is, said Dr. Tang, who had recently shut down a business focused on DNA testing and ancestry.

Like other geneticists, Dr. Tang has long been fascinated by Uighurs because their mix of European and East Asian features can help scientists identify genetic variants associated with physical traits. In his earlier studies, he said, he collected blood samples himself from willing subjects.

Dr. Tang said the police approached him in 2016, offering access to DNA samples and funding. At the time, he was a professor at the Partner Institute for Computational Biology, which is run by the Chinese Academy of Sciences but was founded in 2005 in part with funding from the Max Planck Society and still receives some grants and recommendations for researchers from the German group.

Dr. Beck, the Max Planck spokeswoman, said Dr. Tang had told the organization that he began working with the police in 2017, after it had stopped funding his research a year earlier.

But an employment ad on a government website suggests the relationship began earlier. The Ministry of Public Security placed the ad in 2016 seeking a researcher to help explore the DNA of physical appearance traits. It said the person would report to Dr. Tang and to Dr. Li, the ministrys chief forensic scientist.

Dr. Tang did not respond to additional requests for comment. The Max Planck Society said Dr. Tang had not reported his work with the police as required while holding a position at the Partner Institute, which he did not leave until last year.

The Max Planck Society takes this issue very seriously said will ask its ethics council to review the matter, Dr. Beck said.

It is not clear when Dr. Liu, the assistant professor at Erasmus University Medical Center, began working with the Chinese police. Dr. Liu says in his online rsum that he is a visiting professor at the Ministry of Public Security at a lab for on-site traceability technology.

In 2015, while holding a position with Erasmus, he also took a post at the Beijing Institute of Genomics. Two months later, the Beijing institute signed an agreement with the Chinese police to establish an innovation center to study cutting-edge technologies urgently needed by the public security forces, according to the institutes website.

Dr. Liu did not respond to requests for comment.

Erasmus said that Dr. Liu remained employed by the university as a part-time researcher and that his position in China was totally independent of the one in the Netherlands. It added that Dr. Liu had not received any funding from the university for the research papers, though he listed his affiliation with Erasmus on the studies. Erasmus made inquiries about his research and determined there was no need for further action, according to a spokeswoman.

Erasmus added that it could not be held responsible for any research that has not taken place under the auspices of Erasmus by Dr. Liu, even though it continued to employ him.

Still, Dr. Lius work suggests that sources of funding could be mingled.

In September, he was one of seven authors of a paper on height in Europeans published in the journal Forensic Science International. The paper said it was backed by a grant from the European Union and by a grant from Chinas Ministry of Public Security.

Dr. Tang said he was unaware of the origins of the DNA samples examined in the two papers, the 2018 paper in Hereditas (Beijing) and the Human Genetics paper published in April. The publishers of the papers said they were unaware, too.

Hereditas (Beijing) did not respond to a request for comment. Human Genetics said it had to trust scientists who said they had received informed consent from donors. Local ethics committees are generally responsible for verifying that the rules were followed, it said.

Springer Nature said on Monday that it had strengthened its guidelines on papers involving vulnerable groups of people and that it would add notes of concern to previously published papers.

In the papers, the authors said their methods had been approved by the ethics committee of the Institute of Forensic Science of China. That organization is part of the Ministry of Public Security, Chinas police.

With 161,000 residents, most of them Uighurs, the agricultural settlement of Tumxuk is governed by the powerful Xinjiang Production and Construction Corps, a quasi-military organization formed by decommissioned soldiers sent to Xinjiang in the 1950s to develop the region.

The state news media described Tumxuk, which is dotted with police checkpoints, as one of the gateways and major battlefields for Xinjiangs security work.

In January 2018, the town got a high-tech addition: a forensic DNA lab run by the Institute of Forensic Science of China, the same police research group responsible for the work on DNA phenotyping.

Procurement documents showed the lab relied on software systems made by Thermo Fisher Scientific, a Massachusetts company, to work with genetic sequencers that analyze DNA fragments. Thermo Fisher announced in February that it would suspend sales to the region, saying in a statement that it had decided to do so after undertaking fact-specific assessments.

For the Human Genetics study, samples were processed by a higher-end sequencer made by an American firm, Illumina, according to the authors. It is not clear who owned the sequencer. Illumina did not respond to requests for comment.

The police sought to prevent two Times reporters from conducting interviews in Tumxuk, stopping them upon arrival at the airport for interrogation. Government minders then tailed the reporters and later forced them to delete all photos, audio and video recordings taken on their phones in Tumxuk.

Uighurs and human rights groups have said the authorities collected DNA samples, images of irises and other personal data during mandatory health checks.

In an interview, Zhou Fang, the head of the health commission in Tumxuk, said residents voluntarily accepted free health checks under a public health program known as Physicals for All and denied that DNA samples were collected.

Ive never heard of such a thing, he said.

The questions angered Zhao Hai, the deputy head of Tumxuks foreign affairs office. He called a Times reporter shameless for asking a question linking the health checks with the collection of DNA samples.

Do you think America has the ability to do these free health checks? he asked. Only the Communist Party can do that!

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China Uses DNA to Map Faces, With Help From the West - The New York Times

The thrill of genetic genealogical discoveries should be tempered by ethical concerns – The Jewish News of Northern California

In these times of alarming disregard for scientific data (were talking to you, climate change deniers), lets hear it for science, specifically the astonishing gains made in the field of genetics and genetic testing.

Our three-part Past Lives series highlights the extraordinary resources now readily available to anyone curious about their family ancestry. Easy access to family records on the internet and the mapping of the human genome allows us to peer into our genetic past to learn more about who we are. And we can do both kinds of research from the comfort of our own homes.

For Jews, this has been a blessing for the most part. Unlike those Americans descended from Western European populations who can turn to comprehensive written archives, such as baptismal and marriage records, most Ashkenazi Jews like African Americans and Hispanic Americans lack the paper trail to trace their ancestry back further than a few generations.

Now, with the evolution of genetic testing, we can pinpoint to a remarkable degree of precision the composition of our ethnicity and where we came from. And all it takes is a simple cheek swab.

For some, discovering Jewish roots opens the door to new connections and layers of spiritual meaning.

As our stories show, this technology is about more than percentages and places on the map. For some, discovering the very existence of Jewish roots is a personal marvel, opening the door to new connections and layers of spiritual meaning.

However, as with any technology, ethical concerns run rampant.

Are we now as a global kehillah to rely on DNA test results as a proving ground for belonging to the Jewish people? What about those who convert to Judaism and might hail from different backgrounds? When their DNA pie chart comes back with zero percent Jewishness, does that mean they are any less Jewish?

Though matrilineal descent long ago enshrined a genetic aspect to Judaism, have we not seen enough of eugenics, racism, white nationalism and hate-fueled violence to check a rush to embrace anything that smacks of genetic purity?

These concerns have come to the forefront in Israel, where for the past two years the Chief Rabbinate has been using genetic testing to confirm the Jewishness of immigrants from the former Soviet Union seeking marriage licenses, in cases where the applicants dont have sufficient documentation of their status. Dozens of young couples, and their close relatives, have been humiliated in this way, and the practice is now being challenged before Israels High Court, brought there by the largely immigrant Yisrael Beiteinu party.

Scientific discoveries often involve thorny ethical questions. They must be faced openly.

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The thrill of genetic genealogical discoveries should be tempered by ethical concerns - The Jewish News of Northern California

Myriad Genetics to Present Multiple Studies on Breast Cancer at the 2019 San Antonio Breast Cancer Symposium – BioSpace

SALT LAKE CITY, Dec. 03, 2019 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in molecular diagnostics and precision medicine, today announced that multiple studies will be presented at the 2019 San Antonio Breast Cancer Symposium (SABCS) being held Dec. 10-14, 2019 in San Antonio, Tx.

"We are excited to present new data from several studies at SABCS this year, said Nicole Lambert, president of Myriad Oncology. "Our data represents Myriads commitment to advancing precision oncology for people with breast cancer and improving outcomes.

A list of the companys presentations at SABCS is below. Please visit Myriad at booth #113 to learn more about our portfolio of genetic tests for breast cancer. Follow Myriad on Twitter via @myriadgenetics and keep up to date with Symposium news by using the hashtag #SABCS19.

About Myriad myRisk Hereditary CancerThe Myriad myRisk Hereditary Cancer test uses an extensive number of sophisticated technologies and proprietary algorithms to evaluate 35 clinically significant genes associated with eight hereditary cancer sites including: breast, colon, ovarian, endometrial, pancreatic, prostate and gastric cancers and melanoma.

About riskScoreriskScore is a new clinically validated personalized medicine tool that enhances Myriads myRisk Hereditary Cancer test. riskScore helps to further predict a womens lifetime risk of developing breast cancer using clinical risk factors and genetic-markers throughout the genome. The test incorporates data from greater than 80 single nucleotide polymorphisms identified through 20 years of genome wide association studies in breast cancer and was validated in our laboratory to predict breast cancer risk in women of European descent. This data is then combined with a best-in-class family and personal history algorithm, the Tyrer-Cuzick model, to provide every patient with individualized breast cancer risk.

About EndoPredictEndoPredict is a second-generation, prognostic test that aids personalized treatment planning for patients with early-stage breast cancer. EndoPredict has been validated in over 3500 patients with node-negative and node-positive disease and is the leading breast prognostic in Europe. In contrast to first-generation multigene prognostic tests, EndoPredict incorporates a 12-gene molecular score with known prognostic factors tumor size and nodal status. In clinical studies, EndoPredict demonstrated its robust ability to predict recurrence risk across multiple time-periods: 0-5, 5-10, and 5-15 years. EndoPredict provides clinically actionable information to physicians and patients as they consider the use of adjuvant chemotherapy and extended endocrine therapy.

About Myriad GeneticsMyriad Genetics Inc. is a leading precision medicine company dedicated to being a trusted advisor transforming patient lives worldwide with pioneering molecular diagnostics. Myriad discovers and commercializes molecular diagnostic tests that: determine the risk of developing disease, accurately diagnose disease, assess the risk of disease progression, and guide treatment decisions across six major medical specialties where molecular diagnostics can significantly improve patient care and lower healthcare costs. Myriad is focused on five critical success factors: building upon a solid hereditary cancer foundation, growing new product volume, expanding reimbursement coverage for new products, increasing RNA kit revenue internationally and improving profitability with Elevate 2020. For more information on how Myriad is making a difference, please visit the Company's website: http://www.myriad.com.

Myriad, the Myriad logo, BART, BRACAnalysis, Colaris, Colaris AP, myPath, myRisk, Myriad myRisk, myRisk Hereditary Cancer, myChoice, myPlan, BRACAnalysis CDx, Tumor BRACAnalysis CDx, myChoice HRD, EndoPredict, Vectra, GeneSight, riskScore, Prolaris, Foresight and Prequel are trademarks or registered trademarks of Myriad Genetics, Inc. or its wholly owned subsidiaries in the United States and foreign countries. MYGN-F, MYGN-G.

Safe Harbor StatementThis press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements related to the Companys data across multiple genetic tests being featured at the 2019 San Antonio Breast Cancer Symposium being held Dec. 10-14, 2019 in San Antonio, Tx.; and the Company's strategic directives under the caption "About Myriad Genetics." These "forward-looking statements" are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by forward-looking statements. These risks and uncertainties include, but are not limited to: the risk that sales and profit margins of our molecular diagnostic tests and pharmaceutical and clinical services may decline; risks related to our ability to transition from our existing product portfolio to our new tests, including unexpected costs and delays; risks related to decisions or changes in governmental or private insurers reimbursement levels for our tests or our ability to obtain reimbursement for our new tests at comparable levels to our existing tests; risks related to increased competition and the development of new competing tests and services; the risk that we may be unable to develop or achieve commercial success for additional molecular diagnostic tests and pharmaceutical and clinical services in a timely manner, or at all; the risk that we may not successfully develop new markets for our molecular diagnostic tests and pharmaceutical and clinical services, including our ability to successfully generate revenue outside the United States; the risk that licenses to the technology underlying our molecular diagnostic tests and pharmaceutical and clinical services and any future tests and services are terminated or cannot be maintained on satisfactory terms; risks related to delays or other problems with operating our laboratory testing facilities and our healthcare clinic; risks related to public concern over genetic testing in general or our tests in particular; risks related to regulatory requirements or enforcement in the United States and foreign countries and changes in the structure of the healthcare system or healthcare payment systems; risks related to our ability to obtain new corporate collaborations or licenses and acquire new technologies or businesses on satisfactory terms, if at all; risks related to our ability to successfully integrate and derive benefits from any technologies or businesses that we license or acquire; risks related to our projections about our business, results of operations and financial condition; risks related to the potential market opportunity for our products and services; the risk that we or our licensors may be unable to protect or that third parties will infringe the proprietary technologies underlying our tests; the risk of patent-infringement claims or challenges to the validity of our patents or other intellectual property; risks related to changes in intellectual property laws covering our molecular diagnostic tests and pharmaceutical and clinical services and patents or enforcement in the United States and foreign countries, such as the Supreme Court decision in the lawsuit brought against us by the Association for Molecular Pathology et al; risks of new, changing and competitive technologies and regulations in the United States and internationally; the risk that we may be unable to comply with financial operating covenants under our credit or lending agreements; the risk that we will be unable to pay, when due, amounts due under our credit or lending agreements; and other factors discussed under the heading "Risk Factors" contained in Item 1A of our most recent Annual Report on Form 10-K for the fiscal year ended June 30, 2019, which has been filed with the Securities and Exchange Commission, as well as any updates to those risk factors filed from time to time in our Quarterly Reports on Form 10-Q or Current Reports on Form 8-K. All information in this press release is as of the date of the release, and Myriad undertakes no duty to update this information unless required by law.

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Myriad Genetics to Present Multiple Studies on Breast Cancer at the 2019 San Antonio Breast Cancer Symposium - BioSpace

Why Are These Foxes Tame? Maybe They Werent So Wild to Begin With – The New York Times

In the 1950s, Dmitri K. Belyaev began one of the most famous experiments in animal domestication. Dr. Belyaev, a geneticist at the Institute of Cytology and Genetics in Novosibirsk, Russia, selectively bred foxes that he had acquired from a fur farm, concentrating only on reducing their fear of humans.

Within 10 generations, he wrote in 1979, Like dogs, these foxes seek contact with familiar persons, tend to get close to them, and lick their hands and faces.

In a new paper in the journal Trends in Ecology and Evolution, several scientists have challenged a common interpretation of Dr. Belyaevs results, and have questioned whether scientists who study domestication have any common understanding of what the word means.

The authors dont dispute the essence of Dr. Belyaevs work: the selection for tameness, which is regarded as profoundly important in exploring the genetics and evolution of behavior.

But that wasnt all that Dr. Belyaev discovered. His foxes also showed physical changes, like piebald coats and floppy ears characteristics shared by dogs, cows and other domesticated animals.

Dr. Belyaev and the researchers who followed up his work suggested, as had Charles Darwin before them, that there might be a collection of physical traits that go along with tameness called domestication syndrome.

The authors of the new paper argue that this idea is undermined by an intriguing sub-chapter in the long history of the fur trade in Canada. The reaction to that criticism from other scientists has been mixed, reflecting contentious but cordial disagreements about what domestication is and how it happens.

The average pet lover may know the story of the foxes from a book by Lee Alan Dugatkin and Lyudmila Trut, who collaborated with Dr. Belyaev, called How to Tame a Fox (and Build a Dog).

Far fewer people probably know about the development of fox farming on Prince Edward Island, Canadas smallest province. This history is buried in plain sight, you might say, since you can learn about it easily if you visit International Fox Museum and Hall of Fame on the island.

The museum is not a common destination for evolutionary biologists who specialize in domestication. But one of them did visit back in 2015, and he was taken aback.

The late Raymond Coppinger, a biologist at Hampshire College in Massachusetts who was a major contributor to the study of dog evolution, toured the museum and returned full of questions.

He saw these pictures of spotted foxes, and they looked just like the Belyaev foxes, recalled Kathryn Lord, an animal behaviorist at the Broad Institute in Cambridge, Mass., and the first author of the new paper. Dr. Coppinger was her mentor at Hampshire College.

There have been academic reports as well, suggesting that the Russian foxes hailed from Prince Edward Island, Dr. Lord said: Different pieces of the story were all over, but nobody had put it together.

As it turned out, genetic tests showed that Dr. Belyaevs foxes did have roots in eastern Canada, which almost certainly meant Prince Edward Island. So the question bothering Dr. Coppinger and Dr. Lord was this: How much domestication had gone on before the famous fox experiment began?

She got the attention of Elinor Karlsson, a geneticist at the Broad Institute in whose lab Dr. Lord worked. And she drew in Greger Larson, a specialist in ancient canine DNA at the University of Oxford in England, who is deeply involved in questions of dog evolution and domestication. They began to refine the work Dr. Lord and Dr. Coppinger had already done.

Dr. Belyaev had plainly stated that his foxes were from farmed stock. So some domestication must have occurred before his experiment, said Anna Kukekova, a geneticist at the University of Illinois who researches the genetics of Russian foxes and has collaborated with Dr. Trut.

Dr. Belyaev recognized that fur farmers would have chosen animals that were at least somewhat tolerant of people, Dr. Kukekova said. But Dr. Belyaev also described his foxes as mostly uncomfortable with people, virtually wild animals. Now, Dr. Lord and her colleagues suggest otherwise.

Fox-farming pioneers on Prince Edward Island began by breeding wild-caught black foxes, also called silver foxes, a color variant of the red fox (Vulpes vulpes) common all over the world.

They were bred mainly for the look of the pelts. In 1910, one company sold 25 skins for $34,649.50, according to Silver Fox Odyssey: History of the Canadian Silver Fox Industry.

Then breeding stock became more profitable. Old proven breeders of good quality were valued during the last months of 1912 at from $18,000 to $25,000 a pair, according to a 1913 report by the Canadian government quoted in Silver Fox Odyssey. Eventually the industry declined, and there are only traces of it remaining.

The museum on Prince Edward Island has old photographs that show foxes looking very comfortable with human beings. And as Dr. Lord took a deep dive into fox-farming history, she found other sources suggesting the animals were already somewhat domesticated, including The Black Fox Magazine, a publication for people who hoped to make their fortune raising foxes for their pelts.

The magazine offers a glimpse into a bygone world. For example, an article by F. E. Muzzy in the January 1921 issue described the 1921 International Fox Show in Montreal. Mr. Muzzy wrote that one of the islands fox industry bigwigs, Leo Frank, brought a pair of tame foxes to town, and not only walked them on leashes but took them to a dance where the girls did the fox trot with these foxes around their necks.

Hearsay, of course, but a good story, given the other evidence.

Dr. Belyaevs claims in his landmark article were twofold. One, he had shown how quickly one could select for tameness and tolerance of human beings. The second was that breeding, or selecting for lack of fear in the presence of humans, also had brought about other changes, like floppy ears, spotted coats and differences in tail carriage.

He didnt use the term, but that suite of physical traits came to be known as domestication syndrome. And it was thought to cross species, showing up in cows and goats, for example, as well as foxes.

The idea of domestication syndrome, said Dr. Larson, has been appealing but not thoroughly examined. He, Dr. Lord and their colleagues looked at 10 papers that defined domestication syndrome and found that there wasnt one trait that was included in all the definitions. What the hell are we even talking about here? he asked.

The authors argue that the foxes already showed some of the physical traits that Dr. Belyaev described by the time he got them. His breeding may, however have affected how frequently the traits appeared.

The researchers also note that different species show different combinations of the traits that were proposed to be in the syndrome.

The paper provides the final nail in the coffin to the idea of a universal set of traits characterizing all domesticated animals, said Marcelo R. Snchez-Villagra, a professor of paleobiology at the University of Zurich who studies domestication and was not involved in the study.

But that was not surprising, he added, given other research showing varying processes of domestication. He appreciated the critical look at the fox experiment, because I also think its value has been overestimated.

Dr. Kukekova said she found that critique oversimplified, although she sympathized: I completely understand their frustration with domestication syndrome.

But many aspects of the fox domestication experiment were not presented correctly, she added.

Dr. Belyaev created a pattern of behavior totally different from that of the farmed foxes he began with, Dr. Kukekova said. The old photographs of the friendly foxes were not scientific evidence, she added, and there was no evidence that the foxes actively sought out human interaction, as Dr. Belyaevs did.

She cautioned, however, that there is an enormous difference between a domesticated animal and a pet. The foxes are domesticated, but they are not pets, she said.

Adam Wilkins, a biologist at Humboldt University in Berlin, found the new paper deeply flawed. In a personal letter to the authors, he argued that mammals do share a suite of physical characteristics that go along with tameness.

Dr. Wilkins has argued that mutations in cells in a part of the embryo called the neural crest are linked to behavioral and physical changes.

The fact that different kinds of domesticated animals have somewhat different sets of the affected traits is perfectly consistent with the idea of a syndrome, he wrote in an email.

Asked if there was a working definition of domestication, Dr. Sanchez-Villagra replied, There are as many as there are authors who have provided a definition.

Despite their differences, the spirit of collaboration and scientific discourse among researchers in the quite small field of canine evolution might best be captured by Dr. Wilkins at the end of his letter.

He tempered his criticisms with a friendly note, concluding, We clearly share a strong interest in the subject and I suspect a love of dogs. Here, I attach a picture of my personal favorite domesticated animal, my dog Wolfie.

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Why Are These Foxes Tame? Maybe They Werent So Wild to Begin With - The New York Times

‘Grey’s Anatomy’ Fans Are Pointing Out 1 Major Reason Bailey Is a Total Hypocrite – Showbiz Cheat Sheet

Season 16 of Greys Anatomy has largely focused on Meredith Greys fight to keep her medical license after committing insurance fraud. She made a poor judgment call and has been forced to face the consequences.

The story has gone this far because Miranda Bailey chose to turn in her head of general surgery, and fire those who supported her in her actions. Now, fans on Reddit are calling out Baileys actions, calling her a hypocrite. What happened? Lets take a look.

Late in season 15, Meredith met Gabby Rivera. Gabby came to the hospital complaining of stomach pain. When the young girl first came to the hospital, her father took her to the free clinic because she lacked health insurance. Immediately, it was apparent that the young girl needed more care than the free clinic could provide.

The doctors were sympathetic and Meredith instantly bonded with Gabby. The doctors helped Gabbys father apply for state coverage. When his request was denied because he made too much, Meredith immediately stepped up saying that she had it covered.

As the doctors prepared Gabby for surgery, Alex and Andrew DeLuca, who had also been treating the young girl, questioned Merediths plan. When Dr. Webber entered the scrub room asking why Merediths daughter was in surgery, it was clear. Meredith used her own insurance to cover the girl.

The surgery was a success, but the chief found out. DeLuca initially took the fall, protecting Meredith from jail. But ultimately, the truth was revealed and Meredith, Alex, and Richard lost their jobs.

Over the years we have seen the doctors push the boundaries and toe the line of whats ethical and whats not. Who could forget the infamous LVAD incident or when Meredith interfered with the Alzheimers trial? But there is one particular incident that has Reddit users calling out chief Miranda Bailey.

During Season 5, three women and their husbands were admitted to the hospital after their limo crashed during an ice storm. The episode was filled with emotion, betrayal, and infidelity. But at the heart, one of the women was worried about the insurance she was going to lose the next day.

Bailey was aware of this issue as the husband was rolled into the ER late that night. As the surgery began, Bailey confronted Alex about the time. Though the clock clearly read 2:30 a.m., Bailey insisted it was wrong. She wanted the clock turned back to 11:58 p.m. so the insurance company would have the right time.

Baileys actions were an obvious act of insurance fraud. She knew the man had no insurance and she bent the rules. But when Meredith did the same, her acts were unforgivable.

The storyline came to a conclusion during episode 8 of season 16. In an emotional hearing that involved Meredith confronting the man that killed her husband, every mistake Meredith had made was brought up. Her fellow doctors were left to defend her when faced with facts about her questionable actions.

When Miranda Bailey took the stand, she was flippant, acting as if she wanted Meredith to lose her license. When Richard later confronted Bailey about her actions, she admitted that she had felt betrayed. She lost her hospital, her best friend, and her best surgeons, all because no one came to her.

But had they betrayed her? Richard admitted he didnt tell her because he was protecting her. He didnt want her to lose her job in the fallout of it all. He protected Meredith because he knew Meredith would protect him. And he protected Bailey, because up until recently, he thought she would do the same.

When Bailey was faced with the facts, she had no other choice. She herself had done what she accused the other doctors of doing. She betrayed those closest to her.In the end, she stood up for Meredith and helped her retain her license something everyone expected her to do all along.

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'Grey's Anatomy' Fans Are Pointing Out 1 Major Reason Bailey Is a Total Hypocrite - Showbiz Cheat Sheet

Grey’s Anatomy: Why did Patrick Dempsey leave the series? – Express

Dempsey played the role of Derek from the shows inception in 2005 until 2015, after starring in 11 seasons of the medical drama.

He left the show to focus on his family and his passion for auto-racing.

Speaking to People, Dempsey explained leaving Greys Anatomy was simply the end of a chapter.

He said: Im very grateful for Greys Anatomy. Its given me the opportunity to do everything. But at the same time, there was a cost.

I think after a certain period of time, no matter how much money you make, you want control out of your own schedule.

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Grey's Anatomy: Why did Patrick Dempsey leave the series? - Express

‘Grey’s Anatomy’: Fans Are Still Furious over the Death of This One CharacterThey Claim It Was Worse Than Losing McDreamy – Showbiz Cheat Sheet

There is a lot of heartache on ABCs Greys Anatomy. Fans were torn to pieces whenMerediths(Ellen Pompeo) husband, Derek Shepherd (Patrick Dempsey), tragically died.

Viewers will also never forget the surprising death of Izzie Stevens (Katherine Heigl) love interest, Denny Duquette (Jeffrey Dean Morgan). However, there is one death that fans argue is worse than both of those combined. Lets take a look at who it is and why fans are still upset over it.

While fans typically love the drama of the on-again-off-again couples, sometimes viewers want a sweet, down-to-earth couple who makes you feel good. Henry Burton (Scott Foley) andTeddy Altman(Kim Raver) were once this cute, normal couple.

Well, at least it was as normal as you can get for a Greys Anatomy duo. Henry first came to the hospital as a patient with Von-Hippel-Lindau syndrome without insurance, in need of surgery. Teddy tried to appeal to the hospital, but they offered only a temporary fix. Before he left that day, she suggested they get married so he could be on her insurance.

Henry agreed to the marriage and was able to get his surgery. The pair started as friends (who were married for insurance reasons) but slowly became more. Teddy often would go over to Henrys place after terrible dates and spend excessive time with him.

Fans knew she was falling for Henry before Teddy did. During every one of Henrys surgeries, Teddy became very worried, often acting like a wife. She eventually confessed her love to him, and they became a real married couple.

Of course, right when viewers began to get comfortable with this adorable relationship, Henrys health took a turn for the worst.Cristina Yang(Sandra Oh) operated on a tumor near his heart, but when they opened him up, Richard Webber (James Pickens, Jr.) and Yang found there was too much damage. Henry died on the operating table, and Teddy was devastated right along with the fans at home.

Viewers are convinced that Henry was the best thing to ever happen to Teddy. There are not many fans who like Teddy withOwen Hunt(Kevin McKidd). They continually reminisce about Teddys days with Henry.

Teddy and Henry were such a unique but sensible couple, wrote one Reddit user. I really wish he had stayed alive in the show and moved away somewhere with Teddy. I just never could see Teddy and Owen together, even though they were such good friends.

I always ugly cry when Henry dies, added another Henry fan. I loved this couple so much. They were sweet and normal. They just fit together so well.

Henry was so good for Teddy, reasoned one viewer. I wish they hadnt killed him off. It was also so refreshing to have a character who wasnt a surgeon as a love interest.

Viewers quickly turned a love post about this sweet relationship to a hate post towards the writers of Greys Anatomy.

God, I loved Teddy and Henry, added a Redditor. [They are] still my favorite doctor/patient love story. It was believable. They didnt rush into anything. They met and Teddy offered to marry him so that he could use her insurance. Then they became friends, and then slowly fell in love with each other.

His death hit me harder than Dennys, the Redditor continued. Kims acting was so on point back then, but it has just felt flat in these last two seasons. Teddys speech in season 15, about how Owen is the only one who has ever made her feel rage, is so insulting to Henrys memory.

I dont get it, pondered another fan about the writing comment. Krista was showrunner from season 14 on, and in season 14, the show remembers how much Teddy loved Henry and was furious with Owen.

But then in season 15, they try to chalk it up to her being scared, she continues. If they insist on making Towen a thing, then make it believable. Make us believe that Teddy fell out of love with Owen, and then back in love. Not make it seem like she never moved on.

Fans will continue to debate which death on Greys Anatomy was the most tragic. For now, lets agree on poor Henry. Find out who else is on the operating table when Greys Anatomy returns from winter break on Jan. 23, 2020.

Read more from the original source:
'Grey's Anatomy': Fans Are Still Furious over the Death of This One CharacterThey Claim It Was Worse Than Losing McDreamy - Showbiz Cheat Sheet

Cleanroom technology for the IVF industry – Cleanroom Technology

3-Dec-2019

Design and Build | Pharmaceuticals

In vitro fertilisation is a process that mimics nature and as such, the industry requires state-of-the-art facilities to control environmental conditions and prevent contamination of the product. Giles Palmer explains

From its humble beginnings in a small cottage hospital in Oldham (UK) to its acceptance in mainstream medicine and everyday life, the in vitro fertilisation (IVF) industry has evolved continuously, and is increasingly applicable not only with the treatment of a growing variety of fertility issues but also with challenges of todays society and lifestyle choices.

Globally, infertility affects seven million people: one in six couples have a problem in conceiving. Last year we celebrated the 40th anniversary of the first test-tube baby, Louise Brown, and in doing so the birth of clinical embryology as a profession.

Over the years, IVF success rates have increased. The introduction of hormonal stimulation produced more oocytes than the early natural cycle attempts leading to a more streamlined and controlled treatment cycle leading to a better choice of embryos to transfer, and the need to cryopreserve remaining embryos.

Originally designed for patients with tubal damagewhen the oocyte could not journey from the oviduct to the uterus to implantthe application of this science has been developed to include all forms of infertility, from hormonal disorders to severe male infertility. The shift has seen the opening of new possibilities that have been both morally, spiritual and socially questioned, such as the use of donor sperm and oocytes, sex selection, genetic screening and posthumous use.

These processes are manual manipulations in laminar flow hood with heated work surfaces, cultured in special low volume incubators

Embryologists working in the lab mimic nature, closely maintaining optimum conditions of temperature, pH and osmolarity; monitoring the development of embryos, and selecting the best embryo for transfer. These processes are manual manipulations in laminar flow hood with heated work surfaces, cultured in special low volume incubators.

Culturing outside the body close to physiological conditions has paved the way for new techniques, such as intracytoplasmic sperm injection (ICSI) and preimplantation diagnosis via embryo biopsy coupled with the ever-evolving science of molecular genetics.

Recent advances in cryobiology have also meant that frozen embryos have now succeeded in producing a viable pregnancy as fresh embryos (Thomson, 2019).

Embryos are routinely cultured now to five- or six-day post insemination before being transferred to the intended mother when the embryo has reached the blastocyst stage. This ready-to-implant embryonic stage (previously difficult to achieve with suboptimal culture media) now has a success rate of 54%, according to London Womens Clinic data.

Giles Palmer, Senior Embryologist

The IVF lab is almost always adjacent to an operating theatre where procedures such as egg collection (by follicle aspiration) under sedation and embryo transfer are performed. The eggs and embryos are transferred hand-to-hand, literally, by a hatch (a passthrough you might say in the cleanroom industry) that must remain open for lengths of time up to 30 minutes.

Positive pressure and HEPA filters are commonplace in IVF laboratories, but industry standards are somewhat elusive: there is no consensus on what constitutes an IVF laboratory, and guidelines may differ greatly from country to country.

Only about 15% of IVF clinics are housed within a hospital, and currently may be designed within a medical centre, doctors offices and general buildings.

The IVF process also requires auxiliary rooms. An andrology laboratory (preferably in a separate room but not globally mandatory) is used to process the non-aseptic semen. A cryobiology room is then used to store the frozen samples. Plus, a medical gas room is also required.

Apart from gases used by the anaesthetists, mixtures of medical-grade gasses are required to produce the correct environment within the incubators for the developing embryo; typically 6% CO2 with low O2 tension.

The IVF industry might not manufacture a product, as many industries using cleanrooms, but it seems appropriate to measure success by an endpoint of the birth of a healthy child. Development and normal growth, however, can be limited in adverse air conditions. The entire IVF process is governed by the biology of sperm, egg and embryo, and we must optimise conditions to protect the product against exposure to adverse external factors. The problem lies in the lack of agreement of these conditions.

The human embryo is sensitive to light, temperature and other environmental conditions. Pollutants can settle on workspaces, and although embryos bathed in their culture media overlaid with a layer of light paraffin oil, attention has to be paid to the risk of toxins infiltrating the barrier because embryos lack an immune system to stave off harmful environmental contaminants.

It should be noted that disposables and new equipment can introduce hazards in the laboratory, too

Urban air can contain high levels of pollutants, such as carbon monoxide, nitrous oxide, sulphur dioxide and heavy metals. Indoor construction materials, such as MDF, PVC flooring, paints and adhesives, constitute the major source of volatile organic compounds (VOCs).

Once only anecdotal in the early days of IVF, studies emerged, showing the negative effect of poor air quality and ultimately, pregnancy outcome (Cohen 1997, Hall 1998, Mayer 1999, Boone 1999). It was shown that compressed gases that fed the incubators had high levels of VOCs (namely benzene, isopropanol and pentane) and it was not uncommon for the laboratory environment to have higher VOC concentrations than indoor air.

Particle monitors and VOC counters have also emerged in the IVF marketplace

The industry took notice and has produced ingenious ways to protect the embryos, from closed laminar flow hoods to improvements to filters systems with in-line gas filters and standalone portable air filtration units. Particle monitors and VOC counters have also emerged in the IVF marketplace (Forman, 2004).

It should be noted that disposables and new equipment can introduce hazards in the laboratory, too. Sterile plastic test tubes and dishes in packages need off-gassing. The polystyrene-based plastics can emit styrene (Sing, 2015), and it is good practice to open the consumables well before use and leave in a laminar flow hood. New equipment must also be burnt in (to release residual VOCs from the manufacturing process) in a separate room before use.

While health and safety authorities have safe limits for VOC exposure for humans, there is nothing documented for developing embryos. Industry guidelines were (and still are) vague, but both the European Society of Human Reproduction and Embryology and the American Society for Reproductive Medicine recognise air quality is a key factor to success (ASRM 2014, ESHRE 2004) yet without specific details.

In 2004, the IVF landscape changed in Europe with the announcement of the European Union Tissue and Cell Directive, which specified precise quality and safety requirements for the donations, procurement, testing coding and storing. A key point in this policy was clean air (EUCTD, 2004). It was meant to bring cell and tissue use on par with blood and organ handling.

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The inclusion of the IVF was both unexpected and fiercely debated (Mortimer 2005, Saunders and Pope 2005) because the original specifications would have been detrimental to in vitro embryo development.

The Directive stated: Where tissues or cells are exposed to the environment (...) an air quality of Grade A, as defined in the current European Guide to Good Manufacturing Practice, is required. The background must be demonstrated to guarantee the maintenance of Grade A in the tissue/cell manipulation while in use and unmanned. The document highlighted areas of improvements; there was little or no air management before this draft.

Where tissues or cells are exposed to the environment (...) an air quality of Grade A, as defined in the current European Guide to Good Manufacturing Practice, is required

It was argued that risk of infection is low and that the product cannot be sterilised. Equally, the cooling effects of maintaining airflow of a Grade A environment would have been detrimental to embryo culture and introduce vibrations not conducive to fine accurate manipulation needed in many techniques.

A second draft of the Directive stated a less stringent environment if Grade A was either detrimental or technically impossible, but did not define a level of air quality other than close to A.

In the UK, the Human Fertilisation and Embryology Authority (HFEA), a government watchdog, supported a Grade C working environment with a background of Grade D. From 2007, all manipulations must be within a Class II laminar flow hood. This regulation meant IVF labs at the very least had to make some adjustments to facilities and standard operating procedure. In the design of a laboratory, great care should be placed on location and adjacent rooms, so to avoid proximity to laundry, canteen or pathology labs emitting possible air contaminants. In a hospital environment, however, limited available space is always a problem.

The same deal of attention should be paid during and after laboratory renovation or build. The wrong materials can be the difference between a triumphant inauguration with great IVF success rates or failure with long-lasting effects.

Construction should involve using furniture free of VOCs, preferably stainless steel and low VOC materials and adhesives.

Lab improvements can help increase IVF success by implementing cleanroom standards

In a study following the VOC measurements during a renovation of a laboratory, I was able to show key VOC emissions, such as ethyl alcohol, acetone, hexane and toluene, at various point of construction phases, and ways to alleviate and eliminate the VOCs upon completion of the work (Palmer, 2010). This may be common knowledge to the cleanroom aficionados, but was something quite new a decade or so ago.

Other papers on air quality improvements followed, illustrating how lab improvements can help increase IVF success by implementing cleanroom standards.

Heitmann et al. in 2015, for example, described how a former lab with an unreliable HVAC system was transformed. The project used the strategy of pre-filter, photocatalytic irradiation and chemical filtration, by means of activated carbon, potassium permanganate, and finally HEPA filters. Implantation rates were drastically increased, and clinical pregnancy rate increased by 10%.

Still, as IVF resides predominately in the private healthcare sector, a great variety of different types of facilities exist, from renovated listed buildings of grandeur to purpose-built installations.

There was a clear need for clarity within the existing guidelines on optimal laboratory conditions, but in a recently published article, a survey of 36 clinics using an IVF quality control app globally, little conformity could be found (Palmer, 2019).

Laboratory temperatures varied from 17oC to 35oC, and humidity from 5% to 80%; only four laboratories measured air quality; and only two measured VOCs.

The implementation of stricter guidelines is not always welcome. The mere mention of my talk on this subject at Cleanzone Middle East on social media raised a quiet storm doubting the merits of cleanroom technologies. Those raising an eyebrow pointed to costs, increase in staff required and questioned the necessity. Needless to say, the feedback was from old school scientists who had clearly not read or approved of the recent Cairo consensus published in 2018.

The Cairo meeting of experts was set out in the wake of growing evidence for recommending technical and operational requirements, control of particulates, aspirational benchmarks, and help in laboratory commissioning in the future.

The mere mention of my talk on this subject at Cleanzone Middle East on social media raised a quiet storm doubting the merits of cleanroom technologies

The meeting listed the most common agents of contamination and compared a large number of older facilities with laboratories using cleanroom concepts:

In all, there were over 50 consensus points, and it was concluded that cleanroom design should be implemented in any new IVF laboratory builds.

The global fertility rate continues to decline. Main culprits of this trend are the increase in obesity, environmental factors and lifestyle as well as psychographic changes.

Based on 2019 figures, there are over 3,000 clinics worldwide, and the need for IVF is ever-growing. In the US, 1.5% of all children born are a result of assisted reproduction, while the number is 4% in Australia and Israel, and in Denmark 6.4%.

Several economic sources have valued the market to be approximately US$16 billion, with a compound annual growth rate (CAGR) of almost 10%. If this growth holds strong for the next five years, it would mean an industry worth nearly $40 billion by 2025.

Growth is similar in all areas of the globe and large corporations, backed by venture capitalists, are consolidating chains of clinics. Once a reserve of private consultants or small groups of doctors, IVF clinics have now gone big, resulting in chains of IVF clinics.

The success of freezing produces an ever-increasing inventory of cryo-stored embryos, and estimates from IVF research group TMR forecast 21 million people will have stored samples by 2025

The IVF industry has to invest in new facilities equipped with state-of-the-art technology to keep up with this demand and produce high and reproducible standards. The success of freezing produces an ever-increasing inventory of cryo-stored embryos, and estimates from IVF research group TMR forecast 21 million people will have stored samples by 2025. This is a huge capacity that will need significant infrastructure to back it up.

Driven by technological advances, especially in the field of fertility preservation, we will see IVF clinics even more widespread and frequently used than they are today.

Consulting on various projects, in the UK and abroad, I have seen a huge lack in understanding of what is required to construct and maintain a successful IVF facility. I welcome the introduction of cleanroom companies into the IVF industry, as many aspects of your work and products are applicable to our industry today.

The modular cleanroom initiatives, such as the Shellbe system, are particularly appealing for their capacity to produce a zero VOC laboratory customised to the clients needs.

I welcome the introduction of cleanroom companies into the IVF industry, as many aspects of your work and products are applicable to our industry today

Fickle and demanding, we embryologists may be about the conditions and the design of the IVF clinic, but I am often hampered by lack of local expertise (or material) in various places of the world. As real estate costs and availability become so prohibitive in many cities, the portable, adaptable modular lab can be designed, shipped and constructed like Lego and fit suitably in spaces that were previously unutilised.

With so much evidence and interest in our field, now is the time for the IVF industry to enter the biotechnology arena and be ready for cleanroom technology.

N.B. This article is featured in the December 2019 issue of Cleanroom Technology. Subscribe today and get your print copy!

The latest digital edition is available online.

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Cleanroom technology for the IVF industry - Cleanroom Technology