Ancestry, the genealogy-focused genetics testing company, on Tuesday announced two new products that will provide consumers with health information based on DNA test results—a move that places the company "in direct competition with 23andMe," according to STAT News.
The two AncestryHealth products— AncestryHealth Core and AncestryHealth Plus—will look at 17 genes, including:
- BRCA1 and BRCA2, which increase risk of breast cancer and ovarian cancer;
- MLH1, MSH2, MSH5, and PMS2, which lead to Lynch syndrome that causes colon cancer;
- MYBPC3 and MYH7, which are linked to cardiomyopathy;
- APOB, LDLR, and PCSK9, which can cause familial hypercholesterolemia;
- HFE, which causes hereditary hemochromatosis;
- F2 and F5, which cause thrombophilia; and
- The genes that cause sickle cell anemia and cystic fibrosis.
The products will also test for traits like lactose intolerance and caffeine metabolism. In addition, the tests will include clinical reports that consumers can give to their physicians.
However, the two products provide significantly different services. AncestryHealth Core will provide a one-time report with data based on consumer's DNA microarray. The product will cost consumers $49.
Meanwhile, AncestryHealth Plus will provide a more detailed report to consumers using next-generation DNA sequencing technology. While the AncestryHealth Plus product will initially focus on the 17 genes that the AncestryHealth Core product focuses on, it will technically sequence a consumer's "exome," or" all of the known genes that code for proteins in the body," according to STAT News. However, Ancestry will share only a limited portion of the resulting data with consumers. Consumers interested in the product will pay a one-time fee of $199, plus a $49 subscription fee every six months to receive quarterly reports with updates.
How it works
For the new products, Ancestry is teaming up with PWNHealth, a national network of physicians located in New York. For both products, consumers will order a DNA test from the company and complete a survey of their medical history, which is then reviewed by a PWNHealth physician for DNA test approval. The test results, when ready, are then reviewed by PWNHealth providers to ensure that consumers get the right educational materials along with the findings—for instance, a consumer whose DNA test has potentially worrisome results would also receive an educational video about the condition.
Consumers will also receive video material on DNA testing before getting their results, and, after receiving their results, they will have access to both online resources and, if needed, genetic counselors also from PWNHealth.
According to Business Insider, 23andMe sells many of the same tests Ancestry plans to offer, including reports on carrier status for sickle cell anemia, cystic fibrosis, and Tay-Sachs Disease—and more than 40 other conditions—for about $200. 23andMe's tests can also tell consumers if they have an increased risk of Alzheimer's disease or Parkinson's disease, which Ancestry elected not to include.
However, since AncestryHealth will require physicians, rather than consumers, to order the DNA tests, AncestryHealth will operate under CMS' rules for physician-ordered diagnostic testing. In comparison, 23andMe applied for and received FDA approval so that it could make its DNA tests available directly to consumers without a prescription.
Margo Georgiadis, Ancestry's CEO, said the company elected to have doctors order the DNA tests "so that the consumer not only can find out a risk factor, but they can seamlessly take a lab report with clinically recommended guidelines into the doctor's office so that there's a clear next path for action."
Experts express concern about Ancestry's tests
Some experts expressed concern over how many genetic diseases the tests will provide information on, and said it's unclear how the patient counseling component of the program will work.
Eric Topol, director and founder of the Scripps Research Translational Institute, voiced concerns about the AncestryHealth Plus product in particular, noting that the American College of Medical Genetics advises providers to share information about harmful mutations in 58 genes with patients who have had their exomes sequenced. The AncestryHealth Plus product is "minimal," he said, adding that while it's "a step in the right direction," it's "not in keeping with consensus and practice in the medical community."
However, Catherine Ball, Ancestry's chief science officer, said the company decided to have its tests focus on only highly actionable diseases because it only wanted to include tests that can "improve outcomes for our customers and for their families."
Separately, David Agus, a professor at the University of Southern California, said, "What people don't get is that genetics are a tiny piece of the puzzle." He noted a study Ancestry and Google published in Genetics that found genes account for less than 10% in differences in people's lifespans.
Laura Hercher, director of research in human genetics at Sarah Lawrence College, said just 2% of patients who don't have a family history of disease would be expected to learn something medically useful from a DNA test. "Some people will get medically useful information from this," she said. But "[f]or most, the idea that DNA testing will help your doctor guide your health decisions is an overstatement" and "premature at best."
Robert Cook-Deegan, a professor at the University of Arizona who studies genome ethics and law, worried that many consumers may not understand their own DNA tests. "A lot of whether this is a good thing or a bad thing depends on the quality of their testing," he said. "It depends on the degree to which those physicians are really involved and the degree to which the genetic counseling is truly incorporated into the process."
Others expressed concerns of whether consumers will know they should be getting a different DNA test than the one they chose. For example, if patients wanted a BRCA1 or BRCA2 test because they had a family history of breast cancer, the AncestryHealth Core test will only tell them if their gene has a common "misspelling," meaning that several specific, cancer-causing mutations could be overlooked, STAT News reports. And while the AncestryHealth Plus test would be more likely spot such an issue if it's present, patients could be better off receiving a DNA test, such as those offered by Myriad Genetics, because those might be covered by insurance.
Robert Green, director of the Genomes2People research program at Brigham and Women's Hospital, said he's concerned patients may wrongly think they're at low risk of a disease because of an incomplete DNA test. "The risk, as with other the consumer genomics, is that patients will think this is somehow a comprehensive and encyclopedic investigation of your entire genomic health," he said. However, he added that "[d]iscovering some people who are carrying significant and actionable mutations is better than finding none of them" (Herper, STAT News, 10/15; Ramsey, Business Insider, 10/15; Brown, Bloomberg, 10/15).