Cattle breeding season is about to take off, and the Trans Ova Genetics facility in Sioux Center, Iowa, is preparing for a busy spring of collecting eggs from donor cattle and impregnating heifers and cows to create some of the countrys top-of-the-line cattle.

On a Tuesday afternoon in early March, a team of veterinary technicians collected eggs from a 14-month-old heifer in a squeeze chute. In a process called OPU for ovum pick up, a vet guided a long needle toward the ovary and collected about 15 unfertilized eggs, or oocytes. The process takes about 10 minutes per cow.

Afterward, the eggs and fluid collected from each animal is sent to the next-door lab where embryologists separate the eggs from the fluid and prepare them to be fertilized

During the busy season, the northwestern Iowa facility does as many as 400 OPUs a week.

The company does 30,000 invitro fertilization procedures a year at its facilities and satellite centers throughout the U.S. We run a lot of cattle through the chute, said Paul Loney, director of sales and marketing at Trans Ova Genetics.

Invitro fertilization work keeps vets busy. The number of embryo transfers has picked up dramatically in the past five years as well. In this process, a fertilized egg from one cow is removed and implanted in another who will serve as a surrogate mother. Using this method, an elite cow can produce several calves in a year instead of just one.

Producers are after whats best for their herd, and with all the tools that are out there, you can really make a difference herd-wide pretty quickly, said Ty Hendrix, manager at High Plains Genetics in western South Dakota.

Most customers at the Piedmont, S.D., facility using embryo transfer are aiming to improve their female genetics, Hendrix said. Backed with information from genomic tests and expected progeny differences (EPDs), they can improve their herds with more accuracy, he said.

It will continue to increase the quality of calves on the ground, he said. Better cows are going to continue to produce more efficiently and more highly sought-after offspring.

Embryo transfer and sexed semen are two forms of breeding technology that have become more common among seedstock producers and those who show their cattle. Markets play a role in the number of producers using the technology. Theyre more likely to invest when cattle prices are good.

Costs of the procedures have remained about the same, but veterinarians are able to produce more embryos with each invitro fertilization (IVF) operation.

Veterinarian Travis White, lower right, and other technicians at the Trans Ova Genetics facility in Sioux Center look at an ultrasound monitor as White guides an instrument to collect eggs from a heifers ovaries.

At Trans Ova Genetics, it costs between $160 and $200 to make an embryo through invitro fertilization. Seven years ago, that procedure would have produced three embryos, on average. Today, it can make twice as many, Loney said, and that lowers the overall cost.

He expects that as the technology improves, theyll be able to produce even more embryos with each procedure. Hes excited to see the technology take off.

Its been growing very fast, and its an area thats in its infancy right now, Loney said.

Some say its another part of precision agriculture. Crop farmers are used to keeping an eye on a computer monitor as they roll across their fields. Its all about fine-tuning seeds, nutrients and crop protection so the plant has the best chance at a highly productive life. Now, the same sort of technology is picking up in the cattle industry. Genetic information can help producers pair their best bulls and females and make top-performing calves.

Its all about optimizing inputs to get the desired outputs, said Michael Gonda, assistant professor in the animal science department at South Dakota State University.

Most cattle breed organizations gather genetic information that help producers predict how an animals offspring will perform. Thanks to advances in DNA testing, those EPDs, are becoming more accurate. The traits they can test for are more complex, going beyond birth weight and calving ease.

Gonda expects the technology will get better at revealing traits such as fertility and feed efficiency. He is working to develop new tools for novel traits, such as a DNA test for disease resistance.

It also could help in treating disease. If producers knew how an animal would respond to vaccines, treatments could be tailored to each animal, Gonda said.

The U.S. Department of Agriculture has created a genomic database of beef cattle. A team of scientists in Clay Center, Neb., recently completed a genetic profile of 96 bulls in a project that started in the 1990s. They found a gene associated with brisket disease, a respiratory issue that can kill feedyard cattle.

SDSU will be working to train the next set of experts who could further the field of precision livestock. The university recently received a USDA grant to offer precision livestock training, including genomics research.

Its a two-year summer program for undergraduates, and its goal is to attract minority and economically disadvantaged students to careers in livestock production.

We hope to bring those under-represented in agriculture into the industry and help them develop their career, said Gonda, who will be leading the research program.

During the first summers 10-week session students will explore career options and their research interests. There are programs in animal science, veterinary science and dairy science as well as swine nutrition, gut microbiology, food safety, animal physiology and genomics.

In the second year, theyll spend 10 weeks at an internship with South Dakota, Minnesota or Nebraska companies or government organizations. Pipestone Systems, Cargill and USDA Animal Research are options, Gonda said, adding that it will give them a chance to use what theyve learned in their field.

I think theres a lot of real opportunities to work in that area, he said.

Reach reporter Janelle Atyeo at 605-335-7300, email jatyeo@tristateneighbor.com, or follow on Twitter @JLNeighbor.

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Breeding technology allows quick boost to herd's genetics - Tri-State Neighbor

There's a great variety in nose variation from person to person, yet if you look at different ethnic populations, you will see differences across groups. For example, the distance between the wings of the nose, also known as "nasal alare," are larger in people of West African, South Asian and East Asian ancestry than in people of European ancestry.

So it's easy to understand why many people, past and present, "have this sense that human populations are very distinct and have been separated for a long time," said Mark D. Shriver, lead author of the study and a professor of anthropology at Penn State University. Still, he noted, "human populations have always split and come back together, split and come back together, so there's no separate origin."

In fact, genetic differences between various population groups is not that great. Using noses as just one example, said Shriver, "the surface, the appearance of people in different populations is much greater than what the genetic differences show on average."

To answer this question, Shriver and his colleagues selected 2,637 individuals from a database of about 10,000.

They selected people from four populations: North Europeans, South Asians, East Asians and West Africans. Shriver and his team looked at 3-D photos of each individual and examined the width of the nostrils, the distance between nostrils, the height of the nose, nose ridge length, nose protrusion, external area of the nose and area of the nostrils.

"So we have multiple cameras that image a person's face, either simultaneously or in a carefully constructed series, and from those multiple angles, you can derive the shape of a face as a point cloud," Shriver said. The resulting 3-D image allows you to "take careful measurements usually calibrated down to a tenth of a millimeter," he said.

Through complex analysis of the data, the researchers learned that the width of the nostrils and the base of the nose measurements differed across populations more than could be accounted for by genetic drift.

Genetic drift refers to the fact that some people leave behind more descendants (and therefore more genes) than others just by chance and not necessarily because they are healthier or better survivors.

If not genetic drift, then natural selection must have played a hand in the evolution of nose shape in humans. Natural selection refers to the fact that people better adapted to their environment are the ones who survive and reproduce, leaving behind their genes.

"Natural selection is usually divided into ecological selection, simple survival and sexual selection aspects of mate choice and competition," Shriver said.

Exploring how local climate might have contributed to differences in nose shape, the researchers looked at the distribution of nasal traits in relation to local temperatures and humidity and found that the width of the nostrils strongly correlated with temperature and absolute humidity.

Your nose and nasal cavity function as your personal air conditioner, warming and moistening air before it reaches your lower respiratory tract. In the late 1800s, British anatomist and anthropologist Arthur Thomson observed that long and thin noses occurred in dry, cold areas, while short and wide noses occurred in hot, humid areas.

Since narrower nostrils allow the nose to humidify and warm the air more efficiently, this was probably essential in cold, dry climates; people with narrower nostrils probably fared better and had more offspring than people with wider nostrils in locations farther from the equator.

"Some of the nose variation is really the climate; some of it's not," Shriver said, noting that sexual selection played a role, as well, with people choosing mates based on notions of beauty, such as finding a smaller nose more attractive.

"The fact that we find such big male-female differences in all of the nose traits is also consistent with sexual selection having a hand," he said. Still ecological selection and sexual selection often reinforce each other, and the study provides evidence that both types of selection have helped shape the nose.

The finding might have some practical application, providing important clues in criminal investigations, Shriver said.

"We didn't get into it in this paper, but (the research) is highlighting some of the variety of data we have," he said. He and his colleagues have been creating 3-D photos and collecting measurements and other data on thousands of people for over 12 years.

"The practical application is something we call 'forensic molecular photo fitting': making a phenotypic prediction of a person from evidentiary DNA," Shriver said.

In other words, if a crime victim's identity isn't known, Shriver can deduce what the person might look like based on DNA from their skeletal remains. The appearance of a perpetrator might be based on DNA from some material left behind at the crime scene.

"More than half of my research effort, the end product, will be molecular photo fitting," said Shriver, who offered one example of why there is interest in this application.

"If you can make a phenotypic prediction, maybe that face or even that genetic ancestry can be quite helpful in directing the investigation," Shriver said. "A lot of good detectives and police officers really understand the range of variation within different populations."

Despite grants from the US Department of Defense and other funding sources, some scientists remain skeptical.

"Although interesting, I think that the study oversimplifies the possible adaptation that has occurred by simply evaluating the external shape," said Dr. Stella Lee, an assistant professor at University of Pittsburgh School of Medicine, who was not involved in the research. "The main limitation of this study is that only the external shape of the nose was analyzed rather than actual nasal airflow, humidity and internal nasal measurements."

"The inside of the nose is lined by a multitude of cilia (which look like a shag carpet under the microscope) that are constantly providing clearance of mucus, pathogens and inhaled particulates to the back of the nose by beating in a rhythmic motion," Lee said. "It is amazing that our noses can differentiate between potentially harmful pathogens and innocuous agents."

Still, Lee noted that the authors themselves acknowledged the possibility of oversimplification.

Seth M. Weinberg, an associate professor at the University of Pittsburgh, said anthropologists have long been interested in the nose as one example of human adaptation.

"This study advances our understanding of the complex picture of human facial diversity," said Weinberg, who had no role in this project, though he has collaborated with several of the authors.

The research attempts to connect the "shape of the external human nose to geographically relevant ecological factors" operating throughout our evolutionary past up to the modern day, he said.

"Researchers have only recently begun to uncover the genetic basis of traits like nasal shape in humans," Weinberg said. "Studies like this can help us to frame those genetic findings within a broader context."

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Climate, not just genetics, shaped your nose, study says - CNN

Recently, I read an article promising that medical genetics willmake medicine predictive and personalized through detailed knowledge of the patients genome.

The thing is, the article is from 1940Looking back, we knew almost exactly nothing about the genetic mechanisms of human disease.

While inflated medical promises are hardly peculiar to molecular medicine, that field does seem particularly prone to breathless rhetoric.

Bluster, overstatement and aspirations masquerading as hard targets have no single cause. One reason, surely, is the heady sense of impending omnipotence that accompanies major technological and scientific advances. Charles Darwins theory of evolution by natural selection, the cracking of the genetic code, [and] CRISPR all were followed by grandiose claims of the imminent total control over lifes fundamental processes.

Every generation of scientists looks back and shakes its collective head in condescending disbelief at how little the previous generation knew, rarely stopping to reflect that the next generation will do the same.

Its time to push back. One way is to hold scientists, philanthropists and the press accountable[We should fund]science liberally, but reward knowledge more than market value.Encourage science literacy, not just cheer-leading. And teach skepticism of technology, medicine and the media.

The GLP aggregated and excerpted this blog/article to reflect the diversity of news, opinion, and analysis. Read full, original post:Genetic research: A money laundering business or a gateway to miracles?

The rest is here:
Tame the hype: Is medical genetics plagued by unfilled promises? - Genetic Literacy Project

The project, funded by a $2 million appropriation from the Alabama Legislature to UAB, supports one of the nations first statewide efforts to harness the power of genomic analysis to help identify those at high risk for a genetic disease, and provide a basis for continuing research into genetic contributors to health and disease.

This initiative could be transformative for the state of Alabama, said Selwyn M. Vickers, M.D., UABs senior vice president for medicine and dean of the UAB School of Medicine. We will use the knowledge gained from the AGHI to begin to uncover more undiagnosed diseases, and will potentially rewrite our understanding of the burden of disease on our population. This project can have tremendous impact on the residents of Alabama and stimulate economic development in the state.

The AGHI will recruit a diverse group of participants from every county in Alabama and provide genomic analysis and interpretation to this group free of charge. For some, the results will indicate an increased risk of a disease for which preventive or treatment strategies exist. Those participants will receive genetic counseling and be linked to appropriate medical care. The initiative will also feature a public education campaign about genomic medicine and create a DNA biobank for research.

Immediate benefits for some

In the first year, the initiative plans to recruit 2,000 individuals who will each provide a DNA sample from a simple blood draw. Over a five-year period, the goal will be to increase the database to include genetic information from more than 10,000 people.

Since the Human Genome Project was completed in 2003, weve learned a tremendous amount about the roles of genes in disease, said Bruce R. Korf, M.D., Ph.D., chair of the UAB Department of Genetics and co-director of the AGHI. This project will result in immediate health benefits to some participants, and in the long term will help to address problems of chronic disease and rising health care costs in the state. It will also position Alabama as a leader at the forefront of 21st-century medicine.

The AGHI will engage citizens throughout the state and their health providers in the use of genomic information to guide medical care.

This initiative advances the tremendous work already being done in genomics at HudsonAlpha and at UAB, said Richard M. Myers, Ph.D., president and science director of HudsonAlpha Institute for Biotechnology. Genomics is dependent on several factors, data being one of them. Undoubtedly, individuals will benefit from the AGHI; additionally, the initiative could lead to identification of new genetic diseases and new treatments for those conditions that will benefit Alabamians and the rest of the world. Through the AGHI, we can help make our citizens healthier, and demonstrate the value and power of genomic medicine in creating a new paradigm for health care. HudsonAlpha is proud to partner with UAB for this groundbreaking initiative.

Korf anticipates that those who choose to participate will fall into one of two major categories. Most will be generally healthy, or will be receiving medical care for one or more conditions not recognized to have a genetic cause. The other group will be those with a recognized genetic issue, the origin of which is undetermined. Both groups will provide blood samples that will undergo genomic analysis at HudsonAlpha in Huntsville.

59 genes

The blood samples from the larger group those not known to be affected by a genetic condition will undergo a genotyping array test, assessing some 650,000 identified genomic biomarkers. The genotyping test will look for the presence of variants in 59 specific genes, referred to as actionable genes by the American College of Medical Genetics and Genomics. An ACMG committee, of which Korf is a member, compiled the list in 2013 after an exhaustive search of medical literature. The 59 genes are those that are known to contribute to disease and for which the potential for prevention or treatment exists.

Perhaps the best-known genes on the list of 59 are BRCA1 and BRCA2, which are associated with a genetic risk of breast and ovarian cancer, Korf said. Other genes on the list are known to contribute to the risk of other types of cancers, as well as some cardiac diseases and other conditions.

Participants who test positive for one of the 59 genes on the ACMG list will, along with their primary medical provider, receive that information coupled with genetic counseling to provide interpretation of the results. Referral to appropriate prevention strategies or treatment will be provided through the primary care physician or a specialized provider.

Individuals receiving a report that they have one of the 59 actionable genes will, with help from medical professionals, be able to develop a treatment plan going forward, Myers said. Potential interventions include increased surveillance, surgery or medications to reduce the risk.

Korf estimates 1 to 3 percent of those who undergo testing will show a positive result for one of the 59 actionable genes. The list is continuously being reviewed, and it is likely that, as it evolves, those changes will be incorporated into the AGHI. In addition, a committee within AGHI may decide to add genes to the list for return of results to AGHI participants based on medical priorities important in Alabama.

The number of individuals likely to get a positive report will be small; but the results will be life-changing, possibly lifesaving, for those persons, Korf said. And there is a multiplying effect. If one person discovers they have a genetic risk for a disease of which they were unaware, that potential risk can then be relayed to others in the family, so that they may also take appropriate action.

Participants with a genetic condition of undetermined origin will receive a more extensive evaluation, known as whole genome sequencing, conducted at HudsonAlpha. Analysis and interpretation of those results will also be communicated to the patient/parents and his or her primary medical provider, and participants will be linked to appropriate medical care, potentially including the UAB Undiagnosed Diseases Program or the Smith Family Clinic for Genomic Medicine on the HudsonAlpha campus.

Both HudsonAlpha and UAB have extensive genomics experience in both the research and clinical arenas, said Greg Cooper, Ph.D., faculty investigator at HudsonAlpha and co-leader of the sequencing workgroup for the AGHI. What we know already about the human genome will immediately benefit participants, and what we learn throughout the duration of the initiative will help transform the landscape, not only for participants, but for their families in the short term and all of society long term.

Spring recruiting

Subjects will be recruited beginning this spring at UAB, followed by recruitment efforts at Cooper Green in Birmingham, as well as at UAB clinical operations in Huntsville, Montgomery and Selma, and eventually other sites in Alabama. The blood samples and extracted DNA collected from all participants will be retained in a biobank for future research purposes.

Our goal is to develop a representative cross sample of Alabama residents, broadly representative of ethnic, racial and socioeconomic groups throughout the state, said Matthew Might, Ph.D., director of the UAB Hugh Kaul Personalized Medicine Institute and co-director of the AGHI.

Might, newly recruited to UAB, was appointed by former President Barack Obama to serve as a strategic adviser to the White House Precision Medicine Initiative in 2015. He has a personal interest in the power of genomic medicine, as his son was diagnosed in 2012 as the first case of NGLY1 deficiency, an ultra-rare genetic disorder. Might said the combined resources of the UAB-HudsonAlpha Center for Genomic Medicine, UAB Informatics Institute and the Personalized Medicine Institute will drive groundbreaking research based on the genomic information garnered by the AGHI.

Such a database will be an unparalleled tool for understanding the health risks across different demographics in the state, Might said. It will give researchers working on finding cures to conditions ranging from diabetes to heart disease to epilepsy the knowledge to identify genetic factors that predispose individuals to rare or common disorders, with the hope of developing new approaches to prevention, diagnosis and treatment.

Ethical, legal and social issues will also be addressed by the AGHI, which has formed a bioethics working group to ensure the initiative conforms to the highest ethical principles. Bioethicists, two from HudsonAlpha, one from Tuskegee University and one from UAB, will review all plans and procedures to ensure that appropriate safeguards and protections are in place and guide the initiative on matters such as privacy, security and informed consent. The AGHI will establish an ethics review panel to investigate and respond to potential issues.

The team

The AGHI will have a steering committee to provide oversight on procedures and policies. Edward Partridge, M.D., the director of the UAB Comprehensive Cancer Center, will lead that committee along with Rick Myers, Ph.D., president and science director at HudsonAlpha, and three leaders in the UAB School of Medicine: Etty Benveniste, Ph.D., senior associate dean for Research Administration andDevelopment; Robert Kimberly, M.D., senior associate dean for Clinical and Translational Research; and Toni Leeth, MPH, associate dean for Strategic Planning and Administration.

Greg Barsh, M.D., Ph.D., HudsonAlpha faculty investigator and faculty chair, isa co-director along with Korf and Might.

The AGHI consists of four working groups. The genomics working group is led by Greg Cooper, Ph.D., a faculty investigator at HudsonAlpha, and Anna Hurst, M.D., assistant professor, UAB Department of Genetics. The recruitment working group is led by Mona Fouad, M.D., UAB senior associate dean for Diversity and Inclusion; and William Curry, M.D., UAB associate dean for Rural Health and Primary Care.

The bioethics working group is led by Mariko Nakano, Ph.D., assistant professor, UAB Department of Medical Education; Kim Strong, Ph.D., faculty investigator and director of the ethics and genomics program, HudsonAlpha; Tom May, Ph.D., research faculty investigator, HudsonAlpha; and Stephen Sodeke, Ph.D., bioethicist and professor of allied health, National Center for Bioethics in Research and Healthcare, Tuskegee University. The data and bio banking working group is headed by Jim Cimino, M.D., director of the UAB Informatics Institute; and Jeff Edberg, Ph.D., professor in the UAB Division of Clinical Immunology and Rheumatology.

This story originally appeared on the UAB News website.

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UAB launching statewide genetics initiative to improve health for Alabama residents - Alabama NewsCenter

In an industry dominated by large corporations, local seed company Seitec Genetics has found a way to stand out.

The company, started in 2007, has used several innovative techniques to offer a wide variety of quality corn and soybean seed to farmers in Nebraska and eight other states.

In recognition of the local companys innovation within the industry the Fremont Area Chamber of Commerce has named Seitec as Innovator of the Year.

Obviously we dont do what we do every day thinking about awards or anything like that but it is sure nice to be recognized and know that people are noticing the hard work and what we have been able to accomplish, President Dennis Bracht said.

The company will be honored at the Excellence in Agriculture Awards Luncheon on Tuesday at Fremont Golf Club. The event is scheduled from 11:30 a.m. to 1 p.m.

We have a couple things that we do differently than most seed companies; we pay special attention to quality and actually have higher testing standards than other companies in the industry, Bracht said.

One innovation was implementing the LEAP testing program, which stands for Local Environment Advancement Plots, and allows the company to determine how a variety of seeds will perform in a specific of environment.

We test a broad array of genetics across a lot of different environments and pay special attention to moving forward with products that have local area advancement, Bracht said.

Basically, Seitec is able to plant a variety of seeds with different traits, such as herbicide tolerance and insect resistance, on a variety of plot fields to determine which seed will grow best in that specific environment.

The company uses that data to see which seeds produced the highest yields in a specific environment, and then sells the highest producing seeds to farmers whose fields closely match the test plots.

Our unique process of evaluating products by environment leads to hybrids and varieties that are more highly adapted, more reliable, and higher yielding than traditional product selection, Bracht said.

With help from a specially designed planter, Seitec is able to plant 66 varieties of seed on a single test plot to determine which variety will grow best in that specific environment.

When we are testing we have 60 locations that we are hauling our planter and tractor around to, and that gives us an idea of which traits and genetics will work best over a variety of field conditions, Bracht said.

Along with using testing methods that go beyond industry standards, the independent company can offer a wider variety of seed traits and genetics than most seed dealers.

Some of these other brands they have parent companies like a Monsanto or Syngenta and they have certain traits that they spent a lot of money to develop. We are able to license from all of those companies and really be able to test them all head to head and what it really does is open up the genetics, Bracht said.

Many seed brands are confined to the traits their parent company offers which in turn limits the genetics to which they have access.

Unlike most seed dealers in the area, Seitec has been able to keep most of their operation local, or at least confined within the state. The company conditions their seeds at Blair Seed Services and grows most of their seed in Nebraska.

Blair Seed Services is one of the most modern and seed safe plants in the nation and we grow most of our seed under irrigation right here in Nebraska, Bracht said.

Most of Seitecs seed is grown in areas surrounding North Bend, Geneva and Wood River.

According to Brasch, the Fremont area has provided an ideal place for the business to grow and flourish.

We are a nice sized town and we are right on the edge of where all the actual agriculture is happening so we can remain connected to farmers and still be able to draw resources from surrounding cities, he said.

Here is the original post:
Seitec Genetics honored as innovative business - Fremont Tribune

As Congress continues its debate over the Republican replacement plan for the Affordable Care Act, one bill sponsored by North Carolina Congresswoman Virginia Foxx (R-NC5) is being resoundingly rejected by her hometown newspaper.

Heres how the editorial board of the Winston-Salem Journal explains the Preserving Employee Wellness Programs Act (HR 1313) that was introduced by the 5th District Congresswoman earlier this month:

The Preserving Employee Wellness Programs Act, HR 1313, would allow employers to impose big financial penalties on employees who decline to provide information on their genetics through workplace wellness programs. Employers, in general, dont have that power under existing federal laws that protect genetic privacy and nondiscrimination. But a bill passed Wednesday by a House committee would allow employers to get around that if the information is collected as part of workplace wellness programs, The Washington Post reported last week.

Bill supporters say it gives employers the legal certainty to promote good health and lower health-care costs. They say that, as it is now, federal regulations make it difficult to offer these programs.

This bill, which would be big government run amok, is not the solution. It would allow employers to reward those who share their genetic info with deep cuts to their health-insurance costs, leaving those who dont submit paying substantially more.

So employees would feel pressured to provide their existing genetic information, and possibly submit to genetic testing, or pay the price. That is neither right nor fair. Opponents, including writers to our letters page, are rightly raising heck over this bill that one House committee has already approved.

Read the full editorial from the Journal here.

Learn more about HR 1313 in The New York Times.

Continued here:
Editorial: Time for Congress to kill Virginia Foxx's 'wrongheaded' genetics bill - The Progressive Pulse

HERSHEY, Pa. What if your familys DNA could become the blueprint for your very own precise and personalized treatment for colorectal cancer? Or, better yet, what if it could be used to help doctors screen you earlier for the disease, before it has a chance to strike?

This isnt a science-fictional, futuristic ideal. Cutting-edge research at Penn State College of Medicine and the Penn State Colorectal Diseases Biobank is revealing how genetics play a role in treating this disease.

The team at the biobank takes things one step further, too: They empower patients. Combating illness is as much a psychological battle as it is a physical one, says Dr. Walter Koltun, chief of the Division of Colon and Rectal Surgery and director of the biobank. By filling patients with knowledge about genetic causes of disease and the subsequent care for their life-threatening conditions, they can take an active role in their own treatment.

For patients, the stress is the unknown and the lack of control. If you incorporate their concerns and their responses, they become more compliant with treatments. They understand the rationale for what were doing, Koltun says. I call that, patient-centered care. It really means the patient is the director of the symphony. What they need and how their disease affects them, comes back to genetics what disease they have and how it is interacting with their bodys physiology is different for each patient and is in large part related to their genetics.

Colorectal cancer is the third most-common life threatening cancer in the United States, according to the American Cancer Society. During 2017, it is expected to cause 50,260 deaths in the nation. If everyone age 50 and older were screened, six out of 10 deaths could be prevented, says the U.S. Department of Health and Human Services.

But genetics research at the Colorectal Diseases Biobank is advancing the battle for prevention and treatment.

Learn more about the Biobank in this Penn State Medicine article.

Last Updated March 15, 2017

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Penn State Colorectal Diseases Biobank links genetics and colorectal cancer - Penn State News

News Items

The company, which was recently established through the merger of Valley of the Moon Commercial Poults (VOMCP) and Willmar Poultry/Ag Forte, will invest $22 million to establish and equip a new 83,000-square-foot facility in Terre Haute. The hatchery will produce turkey poults for commercial use.

Select Genetics, which is headquartered in Willmar, Minnesota, plans to break ground on the new facility in April and begin production in the spring of 2018. The company will now have nine turkey facilities in the U.S.

Select Genetics is proud to bring a state-of-the-art turkey hatchery to Vigo County. We value the relationship with and among the community, the Indiana State Department of Agriculture and the Indiana Economic Development Corporation and their ability to appreciate the value of this project for both job creation and the larger poultry industry in Indiana, said J. Douglas, CEO of Select Genetics.

Our company is committed to investing in research and development and to promoting the highest standards of animal welfare. These commitments plus a great business environment in Indiana will allow Select Genetics to remain the premier supplier of turkey poults worldwide, he added.

As an incentive, Indiana Economic Development Corporation (IEDC) offered Select Genetics up to $400,000 in conditional tax credits and up to $150,000 in training grants based on the companys job creation plans. These incentives are performance-based, meaning until Hoosiers are hired the company is not eligible to claim incentives. Vigo County will consider additional incentives at the request of the Terre Haute Economic Development Corporation.

"Having a hatchery in Indiana will complement our states production facilities while creating jobs and adding value to our products," said Ted McKinney, Director of the Indiana State Department of Agriculture (ISDA). "We are fortunate to have Select Genetics, a world leader in poultry breeding, bringing their state-of-the-art genetics and capabilities to the Hoosier state."

The new operations will add to Indianas strong agribusiness sector, which raised more than 19.3 million turkeys in 2015, ranking No. 4 in the U.S.

In todays rapidly changing global marketplace, agriculture will continue to be a foundational sector of Indianas diverse economy, Governor Eric J. Holcomb said. Its exciting to see companies like Select Genetics that are using technology to grow their agriculture operations right here in Indiana. Todays news is a win-win for both the Select Genetics team and for our state, and I look forward to witnessing their continued success.

Select Genetics employs more than 1,400 people across the U.S. With the addition of its first Indiana operation, the company plans to begin hiring in January of next year. Interested applicants will be able to apply online in the near future.

"We are thrilled that Select Genetics has selected the Vigo County Industrial Park as the site for its proposed new facility," said Judith Anderson, President of the Vigo County Commissioners. "We are looking forward to assisting company officials in the coming months during the design and construction phases of this exciting project."

Read more from the original source:
Select Genetics Plans Hatchery In Terre Haute, Indiana - Area Development Online

Consumer genetic tests like 23andMe arent medical devices, and the FDA shouldnt regulate them like blood-sugar meters or pregnancy tests.

By Michael White

What if the Food and Drug Administration decided to regulate your Fitbit? Imagine if the agency declared that dozens of popular consumer devicesFitbits, Jawbones, Garmins, Misfits, and the likemet the regulatory definition of a medical device, and couldnt be sold until the FDA certified that they reached the standards required of clinical-grade technology. While its true that fitness-tracker data is not always especially accurate, we dont need the devices to meet the clinical standards required of a diabetics blood-sugar meter or a pacemaker. Even if the numbers arent perfect, many of us find the data usefuland even funfor learning more about ourselves and our health habits. We dont need the FDA to protect us from that.

Thankfully, the FDA hasnt classified fitness trackers as medical devices. But the agency has over-regulated a different health technology: direct-to-consumer (DTC) genetic tests. Like fitness trackers, DTC genetic tests, such as those sold by 23andMe, offer us non-clinical-grade data about ourselves, data that satisfies our curiosity and can inform our lifestyle choices. Also like fitness trackers, DTC tests pose little risk of harm, and thus should not be regulated at the stifling standard of medical device. Instead, they should be handled like other low-risk consumer health products: Regulators ought to keep DTC testing companies honest in their claims, but also recognize that genetic information is interesting and useful to many people, even if it isnt rigorous enough for a medical diagnosis.

Modern DTC genetic tests became widely available in 2007, thanks to advances in low-cost DNA analysis technology. Taking a DTC test is simple: You order a sample-collection kit from the company, spit in a tube or swab your cheek, and mail it back. A month or two later, you read an analysis of your DNA online, which, depending on the test you take, might include information about your ancestry and your possible genetic predispositions for a range of health-related traits. By late 2013, a leading company in the industry, Google-backed 23andMe, claimed to have sold its genetic test to over half a million customers, under the slogan Living well starts with knowing your DNA. For $99 (just about the price of a Fitbit Flex), 23andMe users received risk estimates for over 250 different traits and diseases, ranging from relatively benign ones like lactose intolerance to serious diseases like cancer.

But in November of 2013, the FDA ordered the company to stop making risk assessments, citing concerns that customers would disregard or bypass their doctors and make bad health decisions based on an inaccurate test. The FDA declared that it considered 23andMes test a medical device that could have significant unreasonable risk of illness, injury, or death, and was therefore subject to regulation. As a medical device, 23andMe could not sell its test until the FDA approved it, which the agency would not do until the company proved the clinical validity and accuracy of its claims.

Critics complained that, by treating 23andMes DTC test as a medical device, instead of as a non-clinical consumer product, the FDA was unjustly locking up personal information that people had every right to know and handing the keys to medical gatekeepers. Is the FDA going to issue Fitbit a cease and desist letter too? asked Duke University bioethicist Nita Farahany, who argued that its absurd to consider something a medical device merely because it provides information that might be relevant to a persons medical care. Writing in The New Yorker, science journalist David Dobbs argued that, by shutting down DTC tests, the FDA was leaving genetics in the hands of a medical establishment that has failed to let people obtain and use the elemental information in their own spit.

Critics also argued that the FDAs logic for regulating DTC tests is built on a flawed premise: Multiple studies, comprising thousands of subjects, had found no evidence that DTC genetic tests caused distress or misunderstanding that resulted in dangerous health decisions. Farahany, together with Robert Green, who directed a National Institutes of Health-sponsored study to understand how DTC users handle their genetic information, noted that the results of these studies suggest that consumer genomics does not provoke distress or inappropriate treatment. FDA policy, however, didnt budge. Answering critics, Jeffrey Shuren, director of the FDAs Center for Devices and Radiological Health, insisted that, while some genetic information can be fun, Alzheimers disease, cancer, and heart disease are serious matters. Therefore, genetic tests for such diseases must meet high standards for accuracy.

But even those opposed to the FDAs action recognized that the government wasnt entirely to blame. The agency has a mandate to protect the public from fraudulent or misleading health products, and, for years, it had engaged with 23andMe to discuss what level of regulation would be appropriate. In the summer of 2013, however, for unknown reasons, the company stopped responding to the FDA. At the same time, 23andMe was advertising increasingly bold claims about its products health value. On its website, it said the test would help customers take steps toward mitigating serious diseases and allow them to find out if your children are at risk for inherited conditionseven though, in the fine print, 23andMe noted that its test was not intended to be used for any diagnostic purpose. 23andMes advertising claims had become a source of controversy among scientists and policy experts, who recognized that the inexpensive technology used by the company and the current state of scientific knowledge were too limited for DTC tests to be of much value in serious health decisions. Writing in The New England Journal of Medicine, health policy experts George Annas and Sherman Elias argued that the FDAs ban is not currently depriving people of useful information.

Furthermore, the ban did not resolve the core tension that has dogged this field from the beginning: People have the right to learn what science has to say about their own DNA, but companies need to be honest about the limited medical value of DTC tests. Michael Eisen, a geneticist at the University of CaliforniaBerkeley and a member of 23andMes scientific advisory board, argued that DTC tests should be regulated fairly tightly, but, at the same time, the government should acknowledge that people have a strong right to obtain the latest scientific information about their DNAeven when the meaning of that information is still unclear.

The challenge, Eisen wrote, is to come up with a regulatory framework that recognizes the fact that this information isat least for nowintrinsically fuzzy. For example, in 2013 23andMes test included 11 genetic variants associated with Type 2 diabetes. The company provided users with a summary of the science and cited the relevant studies, but those 11 genetic variants by themselves are not nearly enough to reliably determine whether someone has a higher genetic risk for diabetes. The big problem is a false negative: Geneticists know that many more variants contribute to the disease, but these remain largely undiscoveredand thus cant be included in 23andMes test. Test users should be able to learn whether or not they carry known diabetes variants, but they also need to be clearly informed about the level of risk associated with a positive resultand why a negative result doesnt mean theyre 100 percent in the clear either. The FDAs job should be to keep 23andMe honest about the uncertainties, not to impose impossibly high standards for accuracy.

Unfortunately, thats not the approach the FDA has taken. In the fall of 2015, 23andMe again began selling its health test, with new, FDA-approved genetic reports. (The company had continued to sell its ancestry test, which was not regulated by the FDA.) But the new health test is now a stripped-down version of its former self, and costs the consumer twice as much as it did before. Instead of reports on over 170 diseases and health-related traits, the test now reports on about 50. The only disease information is presented in roughly 40 carrier reports, which determine whether you carry a mutation for a rare, inherited disease like cystic fibrosis, which you might pass on to your children. 23andMe removed over 100 different diseases and conditions from the new version, including Type 2 diabetes. These are conditions for which scientific knowledge is still, in Eisens words, intrinsically fuzzy, but they are also the ones that most of us are interested in: breast and colon cancer, heart disease, and Alzheimers, to name a few. The FDA still considers 23andMes DTC genetic test a medical device, which means that fuzzy information is not allowedeven if it comes with appropriate cautions and a clear explanation of how confident users should be in their results.

If DTC genetic tests shouldnt be regulated as medical devices, whats the alternative? A better approach would start by treating these tests more like other consumer-wellness productssuch as Fitbits. Like fitness trackers, people buy DTC tests for a variety of reasons, most of which have little to do with making serious medical decisions. Test takers are motivated by a desire to take part in research, to share and discuss their results with others, and to sate curiosity about themselves. Barbara Prainsack, a sociologist at Kings College London, and her colleague Mauro Turrini, at the University of Paris, point to surveys that show what users get out of DTC genetic testing has little, [if] anything, to do with clinical decision-making. The FDA, and the medical community more generally, need to consider the uses of genetic data more broadly. Genomic information, Prainsack and Turrini argue, is personal and social at the same time.

As it turns out, the FDA recently developed guidelines for how it will deal with fitness trackers and the rapidly growing number of mobile applications devoted to health. Rather than treat apps and fitness trackers as medical devices, the FDA has decided to approach these mostly non-clinical technologies from a consumer-protection angle. It has partnered with the Federal Trade Commission, the governments other major consumer-protection agency, and the Office for Civil Rights to focus on protecting the privacy of users data and ensuring that companies dont make misleading claims about diseases.

With some modifications, the FDA could apply this regulatory framework to DTC tests. As long as companies tempered their claims about predicting your genetic risk for disease, or received FDA approval for stronger claims when the science is good enough, they could help us learn what one of the most exciting fields in modern science has to say about one of the most uniquely personal parts of our biology. The cutting edge will always contain uncertainties, but the solution should be to explain those uncertainties, rather than hide them.

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How to Free Personal Genetics - Pacific Standard

A new bill is quietly making its way through Congress that could bring the US a little closer to a Gattaca-like future in which employers could discriminate against their employees based on their genes and risk of disease.

To understand how we might get to Gattaca, lets back up. Under Obamacare, employers are allowed to offer employees deep discounts on health insurance premiums if they participate in workplace wellness programs. The programs often involve medical questionnaires and health assessments which has meant employers can get access to some of their employees personal health data.

Employers embraced the wellness programs. Insurers love them. The Obamacare incentives helped grow the giant workplace wellness industry. And the workplace wellness provisions in the law were some of the only parts of the ACA that received enthusiastic bipartisan support.

Now this new bill, HR 1313 or the Preserving Employee Wellness Programs Act seeks to clarify exactly how much personal health data employers can ask their employees to disclose. And in doing so, the bill also opens the door to employers requesting information from personal genetics tests or family medical histories.

Unsurprisingly, HR 1313 has captured the medias imagination. Vanity Fair suggested the bill could make one sci-fi dystopia a reality. Fortune said workers might soon be forced into genetic tests. On NBCs Meet the Press yesterday, Health and Human Services Secretary Tom Price was asked about HR 1313 which is part of a set of bills that seek to replace pieces of Obamacare and said it sounded like there would be some significant concerns about it.

I reached out to two health law professors the University of Michigan Law Schools Nicholas Bagley and Washington and Lee University School of Laws Timothy Stoltzfus Jost for help parsing the legislation.

As it turns out, employee wellness programs were already very intrusive of employees privacy. It also turns out theyre a bit of a sham and dont work nearly as well as supporters might have hoped to make people healthier or bring down health care costs. But the new bill would allow employers to dig even deeper into participating employees personal health information. While employees wouldnt be forced to join the programs or hand over their genetic test results, theyd have to pay hefty penalties for opting out.

There are four main ways HR 1313 would allow workplaces to access more of their employees personal and family health histories, and potentially use that information to discriminate against their workers:

1) First, the bill would kill legal challenges over whether workplace wellness programs are actually voluntary.

Under Obamacare, people who joined employee wellness programs at work were sometimes asked to submit health assessments or questionnaires. Workers who participated were eligible for a 30 percent (or higher) discount on their health insurance premiums. Employees who didnt participate couldnt get that discount, and therefore paid more for their health insurance.

The health assessments or questionnaires might probe into peoples medical histories, and this created friction with laws such as the Americans With Disabilities Act (ADA). The ADA says employers cant ask their employees to undergo a medical history unless that request is made through a voluntary wellness program. And a 30 percent surcharge is a pretty large sum of money more than $5,400 for the average family plan in 2016 so opting out may not feel optional for many people.

To try and resolve this legal tension, the Equal Employment Opportunity Commission (EEOC), an independent agency involved with overseeing compliance of the AD, got involved in 2016. It determined that if the ACA allows this surcharge, then employers are in compliance with the ADA, meaning that its okay for employers to charge workers who dont opt in to the programs.

The legal ground for that ruling is shaky, according to Bagley, who blogged about the bill at the Incidental Economist. But the new bill would cement the EEOCs interpretation of this: Its also resolving in statute the tension between the ACA and ADA and Congress has never done that before. That means this provision of the ACA would no longer be subject to legal challenges in court, Bagley added.

And so under the new bill, if it passes, if an employer has a medial history questionnaire as part of a wellness program, a worker would need to choose between completing it and paying that surcharge.

2) Second, the bill would allow employers to ask about an employees family medical history or risk paying a surcharge.

Right now, under the Genetic Information Nondiscrimination Act (GINA), wellness programs cannot inquire about an employees family medical history. The reason for the prohibition is simple: If youre on a family plan, employers are helping subsidize all that costly medical care for your sick family members. If you might have a sicker-than-average family, your employer is not going to be too happy to keep you on, said Bagley.

Stoltzfus Jost explained: This keeps employers and insurers from discriminating against people with health problems or genetic predispositions. It also gives people the peace of mind of knowing their employer doesnt have that information.

The new bill would amend GINA and allow employers to start asking about family medical history for the first time. Those who refuse, again, would face that 30 percent surcharge.

So this also leaves employees in a tough spot. It means theyre now open to potential genetic discrimination by their employer or insurers. As Bagley wrote on his blog, Employers arent supposed to use that kind of information to discriminate against you. But theyll be sorely tempted: through your employer-sponsored coverage, theyre on the hook for your familys medical expenses.

3) Third, employers would be able to demand your personal genetic information unless you pay a surcharge.

Under GINA, employers only have the right to access anonymized aggregate data about their employees health thats collected as part of a wellness program. This was already controversial, since in workplaces with a small number of employers it might be easy for employers to tell which employees data they were looking at.

The new bill, once again, goes further: It says that if an employer runs a wellness program that complies with the ACA, then its okay to ask workers for their personal information. So this would mean employers could demand access to the results of genetic tests an employee might have undergone during pregnancy or to determine if shes susceptible to breast cancer, for example.

This, too, is not mandatory per se but if you refuse to give that information, you face that 30 percent surcharge. And again, theres that pesky discrimination problem. Employers aren't supposed to use sensitive information to discriminate, Bagley said, but the whole reason that statutes like the ADA and GINA keep that information from employers is because there's a risk that they may use it anyhow. In a worst-case scenario, for example, they could drop an employee who is at a high risk of a costly genetic disorder.

4) Fourth, the bill transfers more regulatory power from an independent committee to federal agencies

The EEOC is an independent agency involved with overseeing compliance of the ADA, and it also currently has regulatory authority over employee wellness programs.

The new bill would transfer regulatory power from the EEOC to agencies (HHS, Labor, and Treasury) headed by President Trumps Cabinet members.

This is a big shift of authority away from an independent agency that thinks a lot about discrimination to agencies that dont have the same mission and are more subject to the control of the president, said Bagley.

Wellness programs by their nature intruded on employee privacy. In the programs health assessments, they probed into how many hours workers slept, what food and alcohol they ate and drank, and how much they exercised. Thats part of the reason theyve been so controversial.

Many of the news stories on this bill suggest HR 1313 came out of thin air; it didnt. It simply builds on Obamacare provisions by clarifying exactly how much employers can peer into their employees health histories and genetic information and it empowers employers with even more oversight, leaving workers once again in the position of choosing between affordable health care and their privacy.

Employees in places with these wellness programs were already forced to make that choice; under HR 1313, theyll simply have even more to worry about, like whether they want their employer to see the results of a genetics test they had during a pregnancy, or to know that their spouse or mother had cancer or depression.

As Stoltzfus Jost of Lee University summed up, The bill expands or eliminates the employee protections that were pretty weak already.

This is worrisome for anyone concerned with genetic discrimination, genetic privacy, or disability rights, which is why groups like the American Society of Human Genetics have opposed the bill.

Meanwhile, theres actually no good evidence that these wellness programs actually do what theyre supposed to do improve health and bring down health care costs so employers fondness for the programs may be dissipating, Bagley added.

For now, HR 1313 has already been marked up by the House Education and the Workforce Committee, and its now up to House leadership to decide on when to vote on it. Hopefully lawmakers will pay attention to the privacy and discrimination issues and the lack of evidence for wellness programs as the bill moves through Congress.

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A new bill would allow employers to see your genetic information unless you pay a fine - Vox