DNA testing giant Ancestry.com LLC is entering the growing and potentially lucrative field of genetic health screenings with a strategy that's markedly different from that of its biggest competitor.
Ancestry said Tuesday that its new consumer health tests - an area the genealogy-focused company has been slow to embrace - will require authorization by a physician. Its main competitor, 23andMe Inc., went through the lengthy and expensive process of getting approval from the U.S. Food and Drug Administration so it can sell its tests directly to customers without a prescription.
The involvement of doctors in Ancestry's tests places it in the midst of a debate over whether physician-ordered genetic screening is merely a way for companies to avoid the regulatory scrutiny of the FDA. Several other DNA startups, including Color and Veritas, also require a doctor to order health tests.
The FDA hasn't intervened in the field of physician-ordered genetic tests, although it has signaled an intent to do so. So far, a doctor's involvement has been considered enough protection for consumers, even if a patient has little interaction with the physician. It's unclear whether the entrance of a major player like Ancestry might change that.
"I suspect that FDA is going to eventually do something as these tests begin to enter our world in a big way," said Robert Cook-Deegan, a professor at the University of Arizona who studies genome ethics and the law.
Ancestry Chief Executive Officer Margo Georgiadis said the company wanted to focus on providing ways for its tests to integrate easily into the care patients receive from their regular doctors.
"That's really why we chose a path that has a doctor," she said, "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."
After ordering a health DNA test from Ancestry, customers must fill out a brief medical-history survey, which Ancestry then funnels to an outside network of doctors and genetic counselors employed by PWNHealth LLC to approve the test. Once the results are in, those doctors review them and make sure that patients receive the appropriate educational materials alongside their results. For example, if results show a harmful variant of the BRCA 1 or 2 genes, a customer would receive a video explaining hereditary breast and ovarian cancer syndrome. It's a model similar to that followed by other genetic-testing companies.
Ancestry's health tests include free access to a genetic counselor. And before disclosing potentially troubling results, the company requires consumers to watch educational material about the condition. The reports also include clinical reports that a customer can share with their doctor.
"If you have a finding that's important, you will have all the tools you need to learn more about it," said Catherine Ball, Ancestry's chief scientific officer.
But according to Cook-Deegan, the university professor, most consumers may not understand the limitations of the test.
"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."
Companies that offer genetic testing outside of the health-care system should be expected by regulators to show that their tests can successfully be integrated into that system in order to actually improve customers' health, said Michael Murray, the director of clinical operations at Yale University's Center for Genomic Health.
"I haven't seen anything from a company that's doing this from outside of health care that demonstrates anything," he said.
Lehi, Utah-based Ancestry entered the genetic-testing market seven years ago, and with more than 15 million kits sold has become the dominant player in the ancestry DNA testing space.
In its move into health testing, it will introduce two products. Its less-expensive version, AncestryHealth Core, made its debut Tuesday. For $149, it delivers information about a handful of disease risks and health conditions, including breast cancer, as well as the original ancestry test.
A premium product, AncestryHealth Plus, which will launch early next year. It will decode the genome in far greater detail. It will cost $199, with a membership fee of $49 for six months of updates.
Georgiadis said the company didn't plan to seek FDA approval for its tests anytime soon.
"We're a consumer-centric company," she said. "And I truly believe that business models drive behavior. Our goal is to help people gain the preventative knowledge so that they personally can take action for their health."