FDA Tells Google-Backed 23andMe To Halt DNA Test Service

Hugh Pickens DOT Com writes "Bloomberg reports that 23andMe Inc., the Google-backed DNA analysis company, has been told by US regulators to halt sales of its main product, the Saliva Collection Kit and Personal Genome Service, or PGS that tells users whether they carry a disease, are at risk of a disease and would respond to a drug because the kit is being sold without FDA's marketing clearance or approval. 'FDA is concerned about the public health consequences of inaccurate results from the PGS device,' says the agency. 'The main purpose of compliance with FDA's regulatory requirements is to ensure that the tests work.' 23andMe was founded six years ago by Anne Wojcicki, who recently separated from her husband, Google co-founder Sergey Brin. The FDA decided in 2010 that services claiming to evaluate a customer's risk of disease must be cleared by regulators if the companies sell directly to consumers. Most FDA-cleared genetic tests are for a single disease while 23andMe's would be the first to test for multiple conditions. 23andMe submitted FDA applications in July and September of 2012 for the least stringent of two types of medical device reviews but the FDA said the company failed to address 'the issues described during previous interactions'."

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[Anonymous Coward]

It definitely isn't a food or medicine. I don't think this is a health test (phenotype versus genotype) unless you think that genes are unhealthy. (I recall some fascists once thought like that.) It is arguably a medical test -- but so is measuring weight, BP, temperature, pulse, and examining an individual for albinism, eye color, and gender. I guess all companies who state, "You have high BP and you are male; you are at higher risk of cardiovascular disease" and back it up with research should be shut down too.