Five companies that provide genetic testing services—including San Diego’s Illumina (NASDAQ: ILMN), 23andMe and Navigenics in the San Francisco Bay Area, and Knome in Cambridge, MA—no doubt spent the weekend parsing letters issued Friday by the FDA.
The letters, which were posted on the FDA website and signed by Alberto Gutierrez of the FDA’s office of In Vitro Diagnostic Device Evaluation and Safety, notify the companies that genome-sequencing tests they offer to consumers are medical devices that require the agency’s approval. The Food and Drug Administration says it wants to make sure that direct-to-consumer (DTC) genome test kits are “analytically and clinically accurate so that individuals are not misled by incorrect test results or unsupported clinical interpretations.”
The FDA challenge, which also was sent to deCODE Genetics, which is headquartered in Iceland, follows the agency’s move last month to prevent San Diego-based Pathway Genomics from selling its personal genome test kit through Walgreens stores. The letters sent by the FDA do not order the companies to stop selling the tests, but suggests that some genetic testing services they offer may not be marketed legally.
The San Diego Union-Tribune says the FDA letters prompted Escondido, CA-based Palomar Pomerado Health to suspend sales of DNA kits from 23andMe of Mountain View, CA. Palomar Pomerado spokesman Andy Hoang told the newspaper, “we believe the future of medicine is genomics and that personalized medicine, driven by a deeper understanding of the patient’s own unique genetic profile, represents the way medicine will be practiced in the future.
The letters likely were a surprise, as Illumina CEO Jay Flatley said nothing about it when we discussed the FDA’s regulation of personal genome testing the previous day. Illumina declined to comment to the Union-Tribune Friday, except to say the company is studying the content of the letter the FDA sent to Flatley concerning Illumina’s Infinium HumanHap550 array. Illumina doesn’t sell its services directly to consumers, but provides its HumanHap550 array to 23andMe and deCODE Genetics.
Other news accounts explaining the FDA challenge are available at The New York Times and Washington Post, but I found an excellent analysis of the issue by attorney Dan Vorhaus of Charlotte, N.C., here at the Genomics Law Report.