Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office, was quoted in an article titled “FDA Comes Down Hard on 23andMe, Putting Consumer-Directed Genetic Testing on Notice.”
Following is an excerpt:
Providing health reports on an individual’s specific diseases and conditions, carrier status, health risks and drug responses are medical device uses, requiring either premarket approval or 510(k) clearance, FDA tells the Personal Genome Service testing provider 23andMe Inc. in a Nov. 22 warning letter. …
“The 23andMe warning letter is as much a guidance document as it is a warning letter,” said Bradley Merrill Thompson. “I think it was deliberately written to start putting companies on notice to where FDA is planning to draw the line … [on] the difference between disease and wellness,” he explained.
“That said, we really still need that guidance, because there’s a ton of very nuanced details about whether something is truly a disease or wellness.”