Theranos gets another FDA approval for its blood test

On Thursday, Theranos announced that the Federal Drug Administration approved use of a test outside of a clinical laboratory setting.

That approval comes on the heels of another milestone for the company. Earlier this month, the FDA approved one Theranos test, as USA Today reported.

The most recent FDA approval means that Theranos can test patients’ blood taken at one of the Wellness Centers inside Walgreens, currently operating in Arizona and Palo Alto, without having to take the sample to a centralized lab.

The two FDA approvals address some of the skepticism of the blood-testing startup started by Elizabeth Holmes, who dropped out of Stanford as a sophomore and started the firm in 2003.

Holmes owns more than 50 percent of the $9 billion company, making her the “youngest self-made female billionaire,” as Business Insider puts it.

Over the past year, the company has received a lot of press, including a column I wrote last summer. Some have wondered if Theranos could deliver on its promise to revolutionize the medical testing field, as the New Yorker wrote.

Earlier this month, John Ioannidis, a professor of medicine at Stanford, criticized the company for operating in stealth mode in the Journal of the American Medical Association.

Holmes’ vision is to make blood testing so easy — just a prick of the fingertip — and pain-free that people will get their blood tested often. Medicine will be more personalized, she says, with consumers more equipped to take control of their health.

To fulfill that vision, the company faces a host of challenges, including bureaucratic hurdles. Most states do not permit prescriptionless blood tests.

 

Above: Elizabeth Holmes, CEO of Theranos. (Karl Mondon/Bay Area News Group)

 

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