Ancestry, the consumer genetics company that has until now focused on helping people understand their family history, on Tuesday revealed new products that will allow consumers to get health information based on their DNA results — putting it in direct competition with 23andMe.
Ancestry has chosen a very different strategy than its rival. Unlike 23andMe tests, which are ordered by consumers, AncestryHealth products will be ordered by a physician who works for PWNHealth, a New York-based national network of doctors that says on its website that its mission is “to enable safe and easy access to diagnostic testing.” Access to professional genetic counselors, also from PWNHealth, will be included in the purchase price, which will be as low as $49.
Margo Georgiadis, Ancestry’s CEO, told STAT that “consumers decide” sums up the company’s philosophy about how and when people will access genetic counselors. “It’s always about choice and control in that experience for them. We have really tried to create an experience that helps people digest and understand information.”
She said customers will be shown online educational videos about DNA testing before getting results and, afterward, be given detailed online resources to better understand them. Then, if they need it, they might talk to a genetic counselor.
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The fact that physicians — who will not initially see or directly interact with patients — order the tests means that AncestryHealth will not be regulated by the Food and Drug Administration, which regulates 23andMe, but by the Centers for Medicare and Medicaid Services under the rules for physician-ordered diagnostic tests.
“Ancestry has largely escaped much of the controversy that has dogged consumer genomics,” said Dr. Robert Green, the director of the Genomes2People research program at Brigham and Women’s Hospital, who has been paid for consulting from other genetics related companies. “Now by specifically taking their brand into health care, they are inviting the controversy about completeness, about accuracy, about communication, about potential medical miscommunication, about false reassurance — all these different things that we’ve been talking about since 2007.”
The 17 genes included in the AncestryHealth tests include: the BRCA1 and BRCA2 genes, which increase risk of hereditary breast and ovarian cancer; the MLH1, MSH2, MSH5, and PMS2 genes, which lead to Lynch syndrome, which causes hereditary colon cancer; the MYBPC3 and MYH7 genes, which are linked to cardiomyopathy; the APOB, LDLR, and PCSK9 genes, which can cause familial hypercholesterolemia; the HFE gene, which causes hereditary hemochromatosis; the F2 and F5 genes, which cause thrombophilia, a clotting disorder; and the genes that cause sickle cell anemia and cystic fibrosis.
The test will also include results on traits like lactose intolerance and caffeine metabolism, which some experts told STAT were not necessary or appropriate.
Some said that the number of genetic diseases about which the test will provide information is low, and that it’s not clear how patient counseling will work. They also said they have questions about how Ancestry will use the data.
“What people don’t get is that genetics are a tiny piece of the puzzle,” said Dr. David Agus, a professor at the University of Southern California who was an early pioneer in consumer genetics. He points to a statistic that comes from Ancestry’s own research: In a big study conducted with Google (GOOGL) and published in the scientific journal Genetics, genes accounted for less than 10% in differences in how long people lived.
Laura Hercher, the director of research in human genetics at Sarah Lawrence College, said that only 2% of patients who do not have a family history of disease would be expected to learn something medically important from learning about their genomes.
“Some people will get medically useful information from this,” Hercher said. “For most, the idea that DNA testing will help your doctor guide your health decisions is an overstatement.” She called that promise “premature at best.”
Source: Statnews