Popular DNA testing company 23andMe has recently come under fire by way of US regulators concerning the direct sale of its gene analysis service. Regulators could potentially enlist an oversight committee to ensure their more recent tests are offering legitimate results to consumers.
The Food and Drug Administration took action to ban 23andMe for sales of The Personal Genome Test, a test that reportedly provides users with an analysis of their risk for hundreds of genetic diseases. The medical report, according to 23andMe, is the result of intensive DNA data. The FDA will now look to ensure these claims are valid before sales of this particular testing continue.
This is considered an effort on the FDA’s behalf to increase the scope of regulated testing. This push for increased regulations inevitably grew to affect DNA testing, a market analysts anticipate will increase fivefold in size.
The source of DNA testing’s popularity is clearly linked to individuals wishing to receive assistance in their treatment options, especially in cancer cases. Geneticists from respected learning institutions including the University of North Carolina believe such tests are required to prove themselves before being sold to the general public.
The controversy doesn’t end there. Several clients of 23andMe have publicly stated the company misled them concerning the accuracy and validity of its DNA testing. A complaint was filed as of November 27th through federal court systems seeking $5 million, alleging the Personal Genome Service was advertising medical claims prior to securing the all-important FDA authorization.
It’s worth mentioning that 23andMe’s DNA testing has very little in common with actual laboratory testing procedure, instead adopting a direct-to-consumer approach. The recent legal actions by the FDA will undoubtedly change the way DNA testing companies conduct business in the future.