The FDA has released a letter that was sent to 23andMe Inc, a company that sells at-home DNA testing kits, on November 22 requiring that the company halts sales due to concerns over regulatory requirements. The Google backed DNA analysis company was founded six years ago to help people assess their risk of cancer, heart disease, and other medical conditions. 23andMe markets The Saliva Collection Kit and Personal Genome Service (PGS) to determine if customers carry a disease and whether they would respond to a drug. Google co-founder Sergery Brin used the saliva kit to discover he had a gene that makes him susceptible to Parkinson's.
While the testing kits can be used for many different reasons, most of these uses categorize the kit as a medical device, and therefore are subject to FDA approval. Bloomberg reports that the FDA concluded in 2010 that if a service promising to determine a customer's risk of a disease sells directly to the public, they must be cleared by regulators. The 23andMe test kit is unique because it is the first one that tests for multiple conditions instead of a single disease.
In the warning letter addressed by the FDA to 23andMe Inc's CEO and co-founder, Ann Wojcicki, who recently separated from husband Brin, the company was told that marketing these kits without "Marketing clearance or approval" was a violation of the Federal Food, Drug, and Cosmetic Act.
The primary concern regarding these kits is the consequences that inaccurate results may have on the public. 23andMe has agreed to halt sales for the time being, pending FDA approval of their services:
"We recognize that we have not met the FDA's expectations regarding timeline and communication regarding our submission," admitted Catherine Afarian, spokeswoman for 23andMe Inc., in an email. "Our relationship with the FDA is extremely important to us and we are committed to fully engaging with them to address their concerns."
The potential for an FDA approved form of this technology is very lucrative and 23andMe is certain to do all they can to comply with the FDA and begin marketing their kits again.