​Spit-test DNA outfit 23andMe shares health data again after FDA block

DNA-testing startup 23andMe has resumed sending US consumers health reports -- but the regulator-approved versions will provide less detail than before.

23andMe analyses customers' DNA for genetic diseases. Image: iStock
Genetic testing service 23andMe has resumed making its DNA reports available to users after a pause of nearly two years.

23andMe pulled the plug on its health information reports to consumers in late 2013 after the US Food and Drug Administration (FDA) told it to stop, pending a regulatory review.

The company still provided ancestor-related information and raw genetic data but without interpretation, arguably the most valuable part of the service.

According to the New York Times, 23andMe is about to announce that consumers can once again get those reports with FDA approval, only they'll be narrower in scope.

23andMe lets consumers submit a saliva sample to have their DNA analyzed for diseases such as cystic fibrosis, sickle-cell anaemia, and hereditary hearing loss. It then provides its reports to the individual online. The company launched its service in Europe last December.

The company has launched an FDA-approved website for the US with new pricing and details about its service. The service will cost $199 in the US, compared with the original $99.

Formerly, the DNA kit tested for 200 disease risks, traits, and health conditions, while now it will screen for 36 genetic variants associated with diseases, Buzzed reported.

As 23andMe outlines on its website, the service now reports on consumers' 'carrier status', where being a carrier means a person has one variant for a condition but doesn't have the condition, although the variant may be passed on genetically.

While the original goal of the service was to bypass intermediaries, such as doctors and regulators, the new website recommends that users share the results with a doctor to discuss further testing options or discuss the results with a genetic counsellor.

Anne Wojcicki, co-founder and chief executive of 23andMe, told the New York Times that it was still seeking FDA approval to provide information on health risks. New sign-ups dropped by more than half after the company stopped providing it, she said.

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