FDA Goes After More Companies for Selling Unapproved DTC Tests

The FDA has taken Genomic and Healthspek to task for marketing direct-to-consumer tests that appear to meet the criteria of medical devices, but have not been cleared by the agency.

In separate letters to the companies, the FDA highlighted Genomic’s tests for Plavix (clopidogrel) response, Coumadin (warfarin) sensitivity and Nolvadex (tamoxifen) response, as well as Healthspek’s drug metabolism test, which is known as Healthspek PGT.

The agency directs the companies either to provide the FDA clearance numbers for the tests, or explain why they don’t believe that they are required to obtain clearance.

The letters follow similar correspondence sent by the FDA to Kalios Genetics, Harmonyx, DNA-Cardiocheck, DNA4Life and Interleukin Genetics.

The FDA has shrugged off complaints that its efforts are hindering innovation, maintaining it is contacting the companies to make sure the tests are safe and effective (IDDM, Nov. 25).

Genomic tells IDDM the company is preparing a response to the FDA letter, but declined to elaborate because it does not comment publicly on ongoing discussions with regulatory agencies. Healthspek could not be reached for comment by press time.

Read the letters to Healthspek and Genomic here: www.fdanews.com/12-15-FDA-Healthspek.pdf and www.fdanews.com/12-15-FDA-Genomic.pdf. — Jonathon Shacat