After scaring Walgreens out of the genetic-testing business, the FDA has now decided to crack down on the entire industry, and will be subjecting DNA tests to the same rules that it applies to medical devices such as blood-glucose meters.
The agency cites the 1973 Medical Device Amendment, which allows the FDA to regulate “medical devices for use in humans,” and has sent letters to major labs, warning them about the new rules. The letter to popular online service 23andMe, reads in part:
23andMe has never submitted information on the analytical or clinical validity of its tests to FDA for clearance or approval. However, your website states that the 23andMe Personal Genome Serviceâ„¢is intended to tell patients in advance how they will respond to certain medications including warfarin and clopidogrel. It also states that the data generated from the 23andMe Odds Calculator, a feature ofthe 23andMe Personal Genome Serviceâ„¢, includes the contribution of single-nucleotide polymorphisms (SNPs) to disease risk. Consumers may make medical decisions in reliance on this information.
During a meeting between 23andMe and FDA on July 29, 2009, you described the 23andMe Personal Genome Serviceâ„¢ as consisting of a software program that analyzes genetic test results that are generated by an external laboratory in order to generate a patient specific test report. Thus, the 23andMe Personal Genome Serviceâ„¢ is a diagnostic device and subject to all applicable requirements of the Act. You should be aware that FDA does not consider your device to be a laboratory developed test because the 23andMe Personal Genome Serviceâ„¢ is not developed by and used in a single laboratory. Furthermore, we note that you have recently begun distributing the collection kit for your device through a third party distributor, Amazon.com.
Last week, 23andMe admitted sending the wrong data to close to a hundred customers, leading some to worry about whether they were at risk for certain illnesses — and at least one mother to worry that she may have been given the wrong baby at the hospital, based on inconsistent genetic indicators. Industry advocates insist that tighter regulation would not have prevented the mishap.