Concerns Raised About Drugstore Genetic Test
FDA Is Looking Into Claims About New Genetic Test Kit
By Daniel J. DeNoon
WebMD Health News
Reviewed by Laura J. Martin, MD
May 13, 2010 — Walgreens has postponed its plans to sell an over-the-counter genetic test due to FDA concerns that “consumers are putting themselves at risk if they use a test not approved” by the federal agency.
The test, offered by Pathway Genomics, already is offered online. So are similar tests from other companies. None have FDA approval, but the FDA has not previously intervened.
“FDA believes we have regulatory authority over these laboratory-developed tests, but we recognize we have not always used this authority,” FDA spokeswoman Erica Jefferson tells WebMD.
Now Pathway’s planned retail sale of the test has attracted FDA attention. The agency has sent an enforcement letter to Pathway, asking the company to tell it why it does not think it needs FDA approval to sell the test.