As FDA Turns Watchful Eye On Silicon Valley, Health-Related Tech Companies Adjust Mindset On Agency
Those in the highly competitive industry have begun to think of the Food and Drug Administration as an ally instead of a powerful brake on progress.
The Washington Post:
There’s A New Sheriff In Town In Silicon Valley — 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 the Food and Drug Administration. (Cha, 4/28)