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'."

Comments

Democracy?

[operagost]

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

So a bunch of un-elected bureaucrats decided whether same un-elected bureaucrats had the power to regulate a product or service? Mind you, I'm not questioning whether this is a good product or not-- just whether the FDA should be deciding what's in its jurisdiction. Where are the progressives clamoring for "checks and balances"?

Old boys' network

[EmperorOfCanada]

I am 100% sure that this is because 23 and me are cutting out layer upon layer of the traditional health network. Cable would shut down Netflix if they could claim "It's for the children" like the health industry can.

Off the top of my head the layers cut out would include: Doctors, HMOs, Lab techs, companies that distribute the tests, the companies that make the tests, and most importantly the various government departments that deal with all these people. It is not like 23 and me are going to destroy traditional medicine but the last thing that the health industry wants are for their "customers" to grow comfortable going to cheap efficient companies for their medical needs.