The company that offers customers the ability to uncover genetic health risks for only $100 has been asked to stop selling its main DNA testing kit by the Food and Drug Administration due to is failure to obtain “marketing clearance or approval” from federal regulators.
23andMe, a Google-backed genetics analysis company co-founded by Anne Wojcicki, ex-wife of Google co-founder Sergey Brin, sells a “DNA Spit Kit” that’s used to provide users with detailed reports on more than 250 “health conditions and traits,” including risks of Parkinson’s, heart disease, Alzheimer’s, cancer, and hundreds more. 23andMe also claims that its DNA Spit Kit can also help users know how they will respond to particular drug treatments.
In a letter sent to the company last week, however, the FDA says 23andMe must halt sales of this product, which is also known as a “Saliva Collection Kit and Personal Genome Service,” or PGS, without full approval from the agency.
“FDA is concerned about the public health consequences of inaccurate results from the PGS device,” wrote the agency. “The main purpose of compliance with FDA’s regulatory requirements is to ensure that the tests work.”
23andMe has met extensively with the FDA – “including more than 14 face-to-face and teleconference meetings, hundreds of email exchanges, and dozens of written communications,” according to the agency – and submitted to some FDA reviews of its devices. But it has thus far “failed to address” a number of issues regarding the sale and marketing of its DNA test kits and genetics analysis services.
In response to the FDA’s order to halt sales, 23andMe says it plans to work with the agency to ensure all its demands are met.
“We recognize that we have not met the FDA’s expectations regarding timeline and communication regarding our submission,” a 23andMe spokesperson told Digital Trends in an email statement. “Our relationship with the FDA is extremely important to us and we are committed to fully engaging with them to address their concerns.”
At the time of this writing, the $100 DNA Spit Kit is still for sale on the company’s website.