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 doctors' orders.
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 doctors 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 Arizona State University 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.
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. The reports also include clinical reports that customers 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, 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."
Business on 10/16/2019