THE NEWS that researchers have carried out the first known attempt to create genetically modified human embryos is another signpost in an astounding revolution unfolding before our eyes. This is not the first breakthrough nor will it be the last, but it should serve as a reminder an unmistakable one that this realm of scientific inquiry, manipulating the tiny building blocks of life, demands caution as well as enthusiasm and encouragement.

The latest effort, led by Shoukhrat Mitalipov of Oregon Health & Science University, with researchers from South Korea, China, the Salk Institute for Biological Studies in California and others, involved editing the DNA of single-cell embryos with CRISPR-Cas9, a tool for genome engineering that is much simpler, faster and cheaper than earlier methods, and which has sparked an explosion of interest in possible applications. According to a report published Wednesday in the journal Nature, the researchers were able to demonstrate that it is possible to safely and efficiently correct defective genes that cause inherited diseases.

The embryos they modified were not allowed to develop for more than a few days and were not implanted in a womb. In earlier research in China, the modified DNA was taken up by only some cells, not all, and suffered other setbacks, raising questions about its effectiveness. The latest research team reports it achieved efficiency, accuracy and safety with the approach.

If so, the research may be yet another step toward what is called germline engineering, or changing the genetic material in reproductive cells, so that any offspring would pass the changes on to future generations. The potential impact is huge; thousands of inherited diseases are caused by mutations in single genes, so editing the germline cells of individuals who carry these mutations could allow them to have children without the risk of passing on the conditions.

But the dangers and concerns are also significant. The technique could be used to enhance human traits beyond just eradicating disease, such as creating designer babies, or for other malevolent purposes. Genome editing was singled out for concern in a 2016 report to Congress from the U.S. intelligence community about potential wordwide threats: Given the broad distribution, low cost, and accelerated pace of development of this dual-use technology, its deliberate or unintentional misuse might lead to far-reaching economic and national security implications.

In a report this year, a panel of the National Academy of Sciences addressed the potential and the risks of germline engineering, concluding that basic research should proceed, closely watched. But the panel also said, Do not proceed at this time with human genome editing for purposes other than treatment or prevention of disease and disability. This seems to us to strike a reasonable balance, but one that will require vigilance transparency, oversight and public awareness to ensure the fruits of this remarkable revolution are not somehow abused or misused.

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A life-changing genetics breakthrough deserves celebration and demands caution - Washington Post

As a college student at the University of Mount Union in Alliance, Ohio, Megan McMinn studied biology, hoping to one day become a physician's assistant.

But a desire to interact even more with patients led her down a different path in genetic counseling.

"What genetic counseling gave me was a good split between patient care and the hard science research end of things," McMinn said.

At Geisinger Health System in Danville, Pa., McMinn sees about six patients a day, working in oncology. Soon, she'll move onto a cardiology clinic, helping to identify genetic risks for individuals and potentially their families. The system currently has 25 genetic counselors on staff, but anticipates needing hundreds more as genetic testing becomes cheaper and more accessible.

The trend extends far beyond Geisinger, as the field has grown dramatically in the past decade, touching all aspects of health-care as medicine becomes more personalized.

"Genetics permeates everythingthere won't be enough genetic counselors to see every patient who gets genetic information," said Mary Freivogel, president of the National Society of Genetic Counselors (NSGC).

As a result, the Bureau of Labor Statistics projects the occupation will grow by 29 percent through 2024, faster than the average for all occupations

"I think [a genetic counselor] will become a key member of the team, discussing with patients and families what to do next, how to figure out how the genome is going to interact with your lifestyle and make decisions about what you want to do medically," said Dr. David Feinberg, president and CEO of Geisinger Health System.

Genetic counselors typically receive a bachelor's degree in biology, social science or a related field, and then go on to receive specialized training. Master's degrees in genetic counseling are offered by programs accredited by the Accreditation Council for Genetic Counseling, offered at some 30 schools in the U.S. and Canada, according to the NSGC.

Those who want to be certified as genetic counselors must obtain a master's degree from an accredited program, but do not need to be doctors.

The NSGC is also working to recruit new talent by doing outreach in middle and high schools to let younger students know the field is an option in the future. Pay is competitive as wellon average, counselors make around $80,000 a year, but that can increase up to $250,000 annually depending on specialty, location and expertise, Freivogel said.

Health insurance often pays for genetic counseling, and for genetic testing when recommended by a counselor or doctor. However, it's important to check with insurers before scheduling any tests as coverage levels vary. Cost also varies greatly, for example, as multi-gene cancer panels can range from $300 to $4,000 depending on the type of test, the lab used and whether the patient goes through his or her insurance or pays out of pocket.

And while at-home tests like 23andMe are typically less expensive, those taking them still need to see a genetic counselor to explain their results.

Part of the reason more counselors will be needed in the future at Geisinger is because the health system is home to the MyCode Community Health Initiative, one of the largest biobanks of human DNA samples of its kind, according to Amy Sturm, director of Cardiovascular Genomic Counseling at Geisinger. The project has consent from more than 150,000 patients to participate in having their entire DNA code sequenced and synced with their electronic medical records, to look for new causes of disease and different ways to treat conditions.

"We are figuring out and researching the best way to deliver this information back to our patients and also back to families with the ultimate goal of preventing disease and improving the healthcare system," Sturm said.

Keeping up with the latest in genomics, where new developments happen almost daily, can be a challenge. Yet counselors like McMinn say the ability to impact more than just the patient by studying the genome makes the job well worth it.

"We are able to bring to the forefront the fact that we're not just taking care of the patient, but we're taking care of the entire family," McMinn said.

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Genetic counseling field to rapidly expand - CNBC

Personal genetics company 23andMe will be teaming up with the Milken Institute, a think tank, and pharmaceutical company Lundbeck to drive enrollment for a genetic study designed to grasp the underlying biology of major depressive and bipolar disorders.The study will combine cognitive assessments with genetic data and survey responses to assess how genes influence brain processes -- such as attention, decision-making and visual perception -- in individuals who live with these serious mental health conditions.In the United States alone, more than 16 million people are living with a major depressive disorder, according to the National Institute of Mental Health, while nearly 6 million Americans suffer from bipolar disorder. The causes of these disorders are largely unknown, but there are clues: research from the National Alliance on Mental Illness, for example, suggests major depressive and bipolar disorders are caused by a combination of genetic, biological and environmental factors. Other studies back up the hypothesis that theres a genetic component involved.In August 2016 a landmark study was published by 23andMe, Massachusetts General Hospital and Pfizer, detailing the scientific connection between genetics and depression, said Anna Faaborg, Research Communities manager at 23andMe. In that study, we identified 15 genetic regions that were linked to depression. However, even with recent scientific advancements, more research is needed to help accelerate our understanding of these conditions and drive medical discoveries forward. We want to expand on the genetic component, looking at additional phenotypic factors of depression and bipolar, to hopefully gain a more holistic understanding of these diseases.To conduct this research, 23andMe intends to recruit 15,000 people with major depressive disorder and 10,000 people with bipolar disorder. The study is open to anyone aged 18 to 50 who has been diagnosed with major depressive disorder or bipolar disorder, has been prescribed medication to treat his/her condition, lives in the United States and has access to the internet through a desktop or laptop computer.This study is the first to combine data from genetics, cognitive tests and online surveys at this scale, said Faaborg. The hope is to gain a greater understanding of how genetics is related to brain functions such as attention, decision-making and reaction time. This knowledge of the biological underpinnings of disease could ultimately inform the development of novel, disease-modifying therapies.As part of the study, consenting participants will receive the 23andMe Personal Genome Service at no cost, including more than 75 personalized genetic reports about their health, traits and ancestry. Theyll provide a saliva sample for DNA genotyping, and then complete nine monthly online cognitive assessment sessions each lasting between 10-30 minutes. Participants de-identified data will be analyzed for clues as to how genetics and environmental factors combine to impact their brain function and behavior.Participants will receive regular updates about the progress of the study via email or newsletters. If there is a publishable result from the study, 23andMe will publish that information in a peer-reviewed journal and make it open access for all those interested in learning about the findings.At this early stage, we cannot anticipate where the data will lead us or exactly which analyses will be performed, said Faaborg.The study will build on 23andMes body of research in mood disorders. Its launch furthers the companys genetic discovery efforts with research collaborations already established in Parkinsons disease, lupus and inflammatory bowel disease, and more than 75 peer-reviewed papers published in scientific journals

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23andMe to launch study exploring role of genetics in depression, bipolar disorders - MobiHealthNews

Seattle Genetics has agreed to buy the Bristol-Myers Squibb manufacturing plant in Bothell for $43.3 million, giving the biotech the ability to make its own bulk quantities of antibodies for treating cancer.

Special to The Seattle Times

Seattle Genetics has agreed to buy the Bristol-Myers Squibb manufacturing plant in Bothell for $43.3 million, giving the biotech the ability to make its own bulk quantities of antibodies for treating cancer.

Until now the Bothell-based company has relied entirely on contract manufacturers.

Seattle Genetics will continue to use contract manufacturers because of its international footprint, but this will give us our first manufacturing facility that we actually own, said Clay Siegall, the companys chairman, president and CEO.

About 75 people work at the Bristol-Myers facility on Bothells Monte Villa Parkway. Our hope is to keep the team intact, Siegall said Tuesday.

Seattle Genetics now leases seven buildings in its Canyon Park campus, which is about 20 blocks north of the new property.

The company paid $17.8 million for the land and the building, and an additional $25.5 million for the equipment and the building improvements, Siegall said. The deal gives Seattle Genetics ownership of a fully staffed and operating plant that requires little modification.

Were really excited about this, he said. It gives us the ability to control more of our supply chain.

The company will use the plant to make vials of antibodies that are used to treat cancers. Its leading product, Advetris, is now approved for treating patients with two kinds of lymphomas.

Revenue at Seattle Genetics has climbed steadily in the last five years, but so have the losses. Last year the company lost $140million on total revenue of $418 million, according to company reports.

The sale could set the stage for Bristol-Myers exit from the region.

In December the New York-based company said it would not renew a lease that expires in 2019 for its ZymoGenetics unit on Seattles Lake Union. Bristol-Meyers bought the ZymoGenetics research arm in the former Seattle City Light Steam Plant, as well as the production plant now sold to Seattle Genetics, in 2010 for $885 million.

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Seattle Genetics buys biotech factory in Bothell | The Seattle Times - The Seattle Times

Pink areas are bone and blue areas are cartilage in this head skeleton of a larval fish. Craig Albertson of UMass Amherst and a colleague report on experiments that looked at how a gaping behavior, a factor in the fish larvae's developmental environment that precedes bone formation, influences later development of cranio-facial bones. Credit: UMass Amherst

An unspoken frustration for evolutionary biologists over the past 100 years, says Craig Albertson at the University of Massachusetts Amherst, is that genetics can only account for a small percentage of variation in the physical traits of organisms. Now he reports experimental results on how another factor, a "bizarre behavior" that is part of early cichlid fish larvae's developmental environment, influences later variation in their craniofacial bones.

Albertson has studied African cichlid fish for 20 years as a model system for exploring how biodiversity originates and is maintained, with a focus on genetic contributions to species differences. In a new series of experiments with former Ph.D. student Yinan Hu, now a postdoctoral fellow at Boston College, they examined a "vigorous gaping" behavior in larval fish that starts immediately after the cartilaginous lower jaw forms and before bone deposition begins. Results appear in the current early online issue of Proceedings of the Royal Society B.

As Albertson explains, "We predicted that the baby fish are exercising their jaw muscles, which should impose forces on the bones they attach to, forces that might stimulate bone formation." Albertson and Hu observed that gaping frequency, which could reach as high as 200 per minute, varied by species "in a way that foreshadows differences in bone deposition around processes critical for the action of jaw opening."

Albertson, an evolutionary geneticist, says, "For over a hundred years, we've been taught that the ability of a system to evolve depends largely on the amount of genetic variation that exists for a trait. What is ignored, or not noted for most traits, is that less than 50 percent of genetic variation can typically be accounted for by genetics." He adds, "Variation in skull shape is highly heritable, so why can we only find genetic variability that accounts for such a small amount of variability in bone development? In my lab we have shifted from elaborating our genetic models to looking more closely at the interaction between genetics and the environment."

How the environment influences development is known as epigenetics in its original and broadest meaning, Albertson points out. Coined in the 1940s to mean anything not encoded in the nucleotide sequence, it has narrowed to refer to how the 3D structure of the DNA molecule is modified, he notes. "That meaning is true, but it isn't the only one. We're returning to the original definition."

In this sense, gaping is part of "a very dynamic developmental environment," Albertson notes. "Bones are not forming in static lumps of tissue. Rather, they are developing as part of, and perhaps in response to, a highly complex and dynamic system." The fact that species differ in gaping rate led the researchers to test the idea that differences in bone development could be accounted for by variation in this behavior. "We performed experiments to see if we could slow the rate in fast-gaping species and speed it up in slow-gaping species, and to see if this behavioral manipulation could influence bone development in predictable ways."

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Not only did these experiments work, but the magnitude of difference in skeletal morphology induced by these simple shifts in behavior was similar to those predicted to be caused by genetic factors. Albertson says, "What I find really exciting is that in 15 years of manipulating the genetics of craniofacial bone development we can account for up to 20 percent of the variability, so it's modest. When we manipulate gaping behavior, we can influence developmental variability by about 15 percent, which is comparable, almost equal to the genetic response."

The geneticist adds, "When I give talks, this is what surprises colleagues the most, that the environmental effect is on par with the genetic effect, and that it is not systemic but highly specific to important bones involved in fish feeding."

Alberston says this behavior makes sense because "Nature is all about efficiency. Fine-tuning an adaptive response to a particular niche increases the chances of survival. Sometimes longer bones are better, and one way to get there is to kick-start the bone developmental program. This gaping behavior precedes bone formation, so it may represent a way to increase efficiency by setting an animal on the trajectory toward an adaptive phenotype earlier."

He adds, "This is just the beginning. Our field has been entrenched in a gene-centered view of evolution for nearly a century. My hope is that this study adds to a growing body of literature that shows there are other important sources of variation. I hope we can expand the paradigm to consider the environmental context where development takes place, because the effects are likely greater and more widespread than we'd predict."

The next step for his lab will be to figure out how environmental stimuli influence development, Albertson explains. "We now need to understand how bone cells sense and respond to their mechanical environment. What are the molecules that enable this mechano-sensing?"

To this end, the researchers demonstrated that mechanical-load-induced shifts in skeletal development are associated with differences in expression of the ptch1 gene, implicated previously in mediating between-species skeletal shap differences. "That the same molecule is involved in mechano-sensing within species and genetic divergence between species is very cool as it's consistent with evolutionary theory," Albertson says.

The idea is that when an animal population is exposed to a new environment, certain molecules will enable them to respond by conforming their bodies to meet new challenges. If the new environment is stable, natural selection should favor genetic mutations in these molecules that fix the original, transient response. This theory establishes a framework for the initial steps in species divergence. "We think that we now have a molecular foothold into this process," Albertson explains. "These are exciting times."

Explore further: A mechanism of how biodiversity arises

More information: Baby fish working out: An epigenetic source of adaptive variation in the cichlid jaw, Proceedings of the Royal Society B, rspb.royalsocietypublishing.or .1098/rspb.2017.1018

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Evolutionary biologists identify non-genetic source of species ... - Phys.Org