May 2, 2016

FDA new sheriff in town in Silicon Valley

Posted by in categories: biotech/medical, health

Silicon Valley’s newest valley member; wonder if Google or eBay will send a “Welcome Basket” to the FDA?

Helmy Eltoukhy’s company is on a roll. The start-up is a leading contender in the crowded field of firms working on “liquid biopsy” tests that aim to be able to tell in a single blood draw whether a person has cancer.

Venture investors are backing Guardant Health to the tune of nearly $200 million. Leading medical centers are testing its technology. And earlier this month, it presented promising data on how well its screening tool, which works by scanning for tiny DNA fragments shed by dying tumor cells, worked on an initial group of 10,000 patients with late-stage cancers.

Just one thing is holding the company back: Guardant Health has yet to get approval from Food and Drug Administration.

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