The U.S. FDA or the Food and Drug Administration are cracking on 23andMe¸the Company for DNA testing for marketing of their PGS which is Personal Genome Service. In the warning letter dated, 22 November which was addressed to Ann Wojcicki, the CEO, FDA necessitated the Mountain View, company which is California-based to stop selling their testing kits of $99, which uses the sample of saliva buyer to identify the genetic variants which are linked to above 240 “health traits and conditions,” till it receives the authorization of FDA.
The service even claims to recognize the risks, predict the response of drug, and inform the decisions of treatment which uses the requisite approval under Federal drug, Food, and the Cosmetic Act, which is hold by FDA.
The agency which is well followed up with the announcement in Federal Register, publicizing that it is allotting the “guidance” to the companies which produce in the products that are labelled by vitro diagnostic “for only research use” and “for use of investigation only.” The moves can indicate a fresh push for the regulatory control over field of direct-to-customer genomics.
However, accuracy of the DNA test of 23andMe is central to the concerns of FDA. The false positive result can also lead the consumers to seek needless and perhaps destructive screening and treatment, regulators worry, on the other hand the false negative can also allow the major risk to get unnoticed. Moreover, FDA also found the tests predicting the sensitivity of person to specific drugs, which includes the anticoagulant warfarin, to become “mainly concerning,” mentioning that the people may change the dosage or can also discontinue the drug devoid of any professional advice. Also, the letter scolds the 23andMe for not providing the evidence to FDA which their tests work: “Above 5 years after you start marketing, you had not concluded some of studies and had not also started various other essential studies to support the submission of marketing for PGS.”
23andMe has even acknowledged the letter of FDA but has also remained quiet on whether it has plans to continue PGS selling. “We remember that we have yet not met the expectations of FDA with regard to timeline as well as communication regarding the submission,” the company also said in the statement. “The relationship with FDA is incredible significant to us and we are completely committed to entirely engage with them for address the concerns.”