FDA orders genetic testing firm 23andMe to halt sales

FDA orders genetic testing firm 23andMe to be able to halt revenue - Nov. 25, 2013The FDA says 23andMe "has failed to deal with your issues described throughout previous interactions using the Agency."NEW YORK (CNNMoney) The food along with Drug Administration has ordered genetic testing firm 23andMe to stop revenue of its home-testing kits, saying the particular Google-backed business features failed in order to show the validity regarding its product. 23andMe is led through Anne Wojicki, whom co-founded the business in 2006 and recently separated from her husband, Google co-founder Sergey Brin. Google (GOOG, Fortune 500) provides invested millions of money in the company inside recent years. 23andMe provides $99 saliva-testing kits in which consumers use in your personal home and then send for the organization regarding reports in their heritage, their own receptiveness to medications and their genetic danger with regard to dozens regarding wellness conditions. "Strike back just before cancer includes a chance to strike," your California-based company says upon its website. However in the letter dated Friday as well as posted in its website, the particular FDA declared despite extensive correspondence with 23andMe, regulators "still do not need virtually any assurance the firm provides analytically as well as clinically validated your [personal genome service] pertaining to its intended uses." Related: Your race to some $100 genome The Particular agency warned of the prospective health consequences regarding clients whose results include inaccurate positive results pertaining to wellness risks. women whose outcomes indicate the danger pertaining to breast cancer, regarding example, could undertake unnecessary surgery or even chemotherapy. The Actual FDA stated 23andMe "must right away discontinue marketing the actual [personal genome service] until such occasion as it receives FDA marketing as well as advertising authorization." 23andMe stated it "recognize[s] that we now have certainly not met the actual FDA's anticipations concerning timeline and also communication." "Our relationship with all the FDA is very vital that will you us as well as we are dedicated to fully engaging together with these phones address his or her concerns," the organization stated in a statement. Wojicki has claimed which 23andMe has already mapped the actual genotypes of nearly 500,000 people. The Particular company's title is a reference towards the 23 chromosome pairs present inside human cells. FDA spokeswoman Erica Jefferson mentioned the agency "supports innovative products that could be demonstrated to be able to work as claimed." "The FDA spent a while working and can continue to function closely along with just about any company marketing direct-to-consumer genetic tests without stifling innovation," your woman said. Any selection associated with commercial genetic testing companies emerged within latest years, though most aren't regulated. the sector continues for you to be criticized from the Government Accountability Office, which usually warned inside 2010 which customers were receiving results "that are usually misleading and also regarding little if any practical use." The Particular FDA announced promises to regulate genetic screening throughout 2010, nevertheless has but in order to issue guidance about the subject, according towards the National Human Genome Study Institute. Your agency has been handling its enforcement responsibilities on a case-by-case basis. Really Does patenting genes obstruct research? Actress Angelina Jolie produced headlines earlier this coming year when your woman announced her decision in order to go through any preventative double mastectomy based on the results of the genetic test showing any cancer risk. First Published: November 25, 2013: 5:13 PM ET