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Monday, Oct 19 2015

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FDA Scrutiny Raises Questions About Theranos' 'Breakthrough' Blood Tests

In the wake of a Food and Drug Administration warning letter to the testing startup, news outlets report on Theranos' hyped technology that the company says can screen for diseases with only a few drops of blood from a finger prick.

Theranos, a closely watched start-up that vowed to revolutionize medical testing, said on Friday that because of questions raised by the Food and Drug Administration, it had temporarily halted its trademark practice of collecting tiny blood samples from finger pricks. The privately held Theranos has reportedly been valued at more than $9 billion, roughly akin to the laboratory giants Quest and LabCorp. That is based on Theranos鈥檚 purported ability to perform dozens of medical tests using only drops of blood from a finger, rather than the conventional larger vials collected from the crook of the arm. (Pollack and Abelson, 10/16)

On Theranos Inc.鈥檚 website, company founder Elizabeth Holmes holds up a tiny vial to show how the startup鈥檚 鈥渂reakthrough advancements have made it possible to quickly process the full range of laboratory tests from a few drops of blood.鈥 The company offers more than 240 tests, ranging from cholesterol to cancer. It claims its technology can work with just a finger prick. ... But Theranos has struggled behind the scenes to turn the excitement over its technology into reality. (Carreyrou, 10/16)

A deeply reported story by the Wall Street Journal has pulled the curtain back on Theranos, the hot and intensely secretive Palo Alto, Calif., company that aims to revolutionize how we get our blood tested. The newspaper's investigation raises questions about the accuracy and also the novelty of what the company is doing. Here's a guide to the growing questions about this company, the industry, and why it matters. (Johnson and Cha, 10/17)

A few days ago, the chief executive of one of the hottest and most secretive health care companies was named one of "five visionary tech entrepreneurs who are changing the world" by the New York Times. Elizabeth Holmes, the head of blood testing company Theranos, has also appeared on the cover of Fortune, was the subject of an admiring profile in the New Yorker, and was this month splashed on the cover of Inc. with the understated headline "The Next Steve Jobs." A deeply reported investigative story by the Wall Street Journal on Thursday revealed that despite its $9 billion valuation and its board made up of political heavyweights -- including Henry Kissinger and former secretary of state George Shultz -- Theranos' actual revolutionary technology may be falling flat. (Johnson, 10/16)

This is part of the Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.
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