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Tag Index  /  Showing 1 - 2 of 2 results for “consumer genomics”

Bio & Life Sciences Business

Can Hot Consumer Genomics Startup Helix Keep the FDA at Bay?

A new company launched by the market leader in DNA sequencing aims to bring genomics to the masses. Helix, kicked off on August 18 with a capital injection of more than $100 million, appears to embrace a direct-to-consumer approach that hasn’t been seen since pioneer 23andMe's ready-to-mail spit kits. Given the FDA’s firm pushback against 23andMe, though, does Helix has a bright future?   More

Bio & Life Sciences Business

FDA Tells 23andMe to Stop Selling DNA Tests

Citing concerns "about the public health consequences of inaccurate results" from its Personal Genome Service, the FDA on Friday told 23andMe CEO Ann Wojcicki in a stern Warning Letter that her company must "immediately discontinue marketing" the service "until such time as it receives FDA marketing authorization for the device." The Twittersphere responded with shock and some outrage.   More