23andMe, the Google‐backed personal genomics company ordered by the Food and Drug Administration to stop marketing its health‐related services in November last year, is closer to a reconciliation with the government agency. The FDA did not object to the ancestry information 23andMe provides, but rather the information on inherited risks it released to customers.
Before halting the release of health information 23andMe had provided its customers with information on their ancestry and health. 23andMe gathered genetic information from customers by having them send saliva in a $99 kit.
What had the FDA concerned was the possibility that a false result from a 23andMe test could lead to customers undergoing drastic procedures such as “prophylactic surgery, chemoprevention, intensive screening, or other morbidity‐inducing actions.” Reason magazine’s Ron Bailey pointed out such a fear is misplaced because not only is the biochip used by 23andMe and researchers around the word very accurate, anyone who received worrying health news from a 23andMe test would almost certainly consult a doctor and/or get a more comprehensive screening done before undergoing any surgery or procedure.
Last week 23andMe’s Chief Legal and Regulatory Officer, Kathy Hibbs, wrote on the company’s blog that the FDA had “accepted for review 23andMe’s submission for a new 510 (k) application,” which Reuters describes as “a regulatory process that applies to most medical devices sold in the United States.” The FDA considers the 23andMe saliva collection kit a device.
Although 23andMe’s submission focuses on one condition — Bloom Syndrome — Hibbs wrote the following:
Once cleared, it will help 23andMe, and the FDA, establish the parameters for future submissions. More importantly, for our customers, it marks a baseline on the accuracy and validity of the information we report back to them. The submission includes robust validation data covering major components of our product such as the genotyping chip, software and saliva kit.
While it is good news that 23andMe seems to be on its way to being in good standing with federal regulators, Stephanie M. Lee of SFGate.com notes that 23andMe could potentially face months of questions and data requests before being granted FDA approval.