FDA sends warning letter to 23andMe

On November 22, 2013 the FDA sent a warning letter to 23andMe:

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm376296.htm

The FDA listed “particularly concerning” intended uses including the assessment of BRCA-related genetic risk and response to drugs such as warfarin.

The FDA indicated that 23andMe submitted 510(k) applications in 2012 for several of these conditions but had since failed to address the issues that the FDA raised and the specific feedback they provided regarding study protocols, statistical advice, and risk mitigation strategies.

In the warning, FDA orders 23andMe to stop marketing its $99 mail-order saliva kit – indicating that it is high risk, has not received marketing clearance and can potentially deliver false positive or negative results.

New York state and Maryland already had restricted the availability of 23andme genetic testing because they were not ordered by a physician.

Other Direct to Consumer (DTC) genetic tests have shut down in recent years including: deCodeme , TruGenetics, Navigentics, deCode; have been purchased or transitioned to physician ordering only.

We note that other genetic tests available on the market are not “direct-to-consumer” and are ordered only by licensed physicians including InVitae, Pathway Genomics, DNATraits, and others.

FDA has not ordered 23andMe to stop selling it’s testing service, rather to stop marketing the solution and making medical and health claims that are not supported.

We note that FDA just granted approval for marketing of the Next Generation Sequencer from Illumina – the MiSeqDX – and acknowledges the importance of personalized medicine and genetic sequencing.