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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'."
I can see why cheap and reliable genetic testing you can do without the intervention of medical industry is frightening. For one hundred dollars you can find out if you have markers that put you at elevated odds of hundreds of conditions. If this came from the traditional medical, you would have to go to a doctor who would release the results to your insurance company, it would cost about $1000, and you wouldn't even get to see the results yourself unless the doctor wanted to show you something.
I've done the 23andMe testing and it has been of value. I'm not in close contact with much of my extended family and have almost no contact with the family on my father's side. It doesn't claim to diagnose or treat diseases or traits. What it does do is tell you if you're at elevated odds for a few select conditions, along with heritable traits. This is can be invaluable if you don't know that much about the medical history of your family.
Pregnancy tests are also regulated as medical devices. They cost $5.
23andMe can grow up and have their work validated clinically. Or they can find an industry where accuracy is not regulated.