23andMe redux? Startup DNA4Life gets FDA warning letter on DTC genetic testing kit
- Louisiana-based DNA4Life has launched a $249 DNA test, which is intended to predict drug response.
- The CEO of the company, Richard Zimmer, said that he is aware of the regulatory issues surrounding DTC genetic tests and that his company's test should not require FDA approval. He was proven wrong on Monday when the agency sent the company a warning letter over the product, which it said was unapproved.
- For the last two years, 23andMe, a well-known DTC genetic testing company, has been working with the FDA to gain approval for its test—after having the agency order the non-approved version of its test off the market in 2013.
The question here is: Why is 23andMe getting approvals on a spectrum of its carrier-screening tests and working with the FDA on its other products, while Zimmer launched his company's test into the market without any regulatory oversight?
According to Zimmer, tests such as the DNA4Life test are regulated as lab-developed tests under guidelines from the Clinical Laboratory Improvement Amendments (CLIA). These guidelines do not require companies to prove clinical validity.
The FDA clearly thinks otherwise. Zimmer has said he is open to a conversation with the agency.
As it stands now, pharmacogenetics tests are ordered directly by a physician and are not available to consumers—and they are also much more expensive than the DTC tests.
It seems now that Zimmer had a lot of chutzpah to launch this test at a time when 23andMe is slogging through regulatory hurdles and playing by the rules. And now, his company is going to have to work with federal regulators to a similar degree.