Monday, October 26, 2015

Theranos CEO: Elizabeth Holmes, 31, Pushes “Pause” Button

Not so fast, McDuff

William Shakespeare

Due to a series of October 14-23 WSJ articles questioning the validity and deliverability of Theranos testing methods, a Food and Drug decision that Theranos “nanocontainer” is an unapproved medical device , and WalGreen’s halt in their testing using Theranos tests, Elizabeth Holmes has announced a “pause period” as it seeks FDA approval of its propriety Edison technology.

The WSJ and Elizabeth Holmes are exchanging conflicting statements about the accuracy of Theranos tests.

This is the third blog I have written about Theranos. The titles of the first two speak for themselves.

One, April 17, 2015, “Theranos, Disruptive Innovation, and Creative Destruction of Clinical Laboratory Industry”

October 16, 2015, “ 240 Tests on a Single Drop of Blood, Too Good to be True”

These latest developments are a setback for Theranos and for Silicon Valley’s golden girl, Elizabeth Holmes, whose company has attracted $9 billion in venture capital value.

California is the land of the information technology gold rush, a land where young entrepreneurs are making billions, seemingly on the blink of an eye.

Until now, Theranos was the hottest IT game in town.

She is a heroine to IT geeks for style and imagination.
As explained in The New Times Style Magazine (October 25),
“Theranos, a complete blood count and electrolyte tests, taken by a single finger prick, costs $10.17. Her goal? To democratize health care. Turning a blood test into an inexpensive, essential and even (almost) pleasant experience rather than an expensive, dreaded, and time-consuming procedure – makes people more likely to get testes. As a result, medical problems can be identified earlier, enabling the prevention and effective treatment of disease ranging from diabetes and health aliments to cancer.”

Suddenly, as the result of the WSJ articles and a Food and Drug Administration investigation into the validity of Theranos claims about the accuracy of its proprietary Edison testing methods and unapproved medical device “nanocontainers" used to collect finger-pricked blood, Ms. Holmes’ dream of revolutionizing the clinical laboratory industry is on hold.

As a clinical pathologist who has been writing about screening laboratory tests since 1974 (“The Screening Laboratory of 1980,” Perspectives in Biology and Medicine, Winter, 1974), Theranos may have other challenges as well.

1) Many states do not allow patients to order clinical tests directly, nor do they allow laboratories to report results directly to the patients.

2) Patients may not have the requisite knowledge to interpret the clinical significance of tests.

3) When many tests are performed at once, it is inevitable many tests will fall just outside the normal range but be clinically insignificant.

4) Large scale testing my compromise the privacy of test information.

These considerations aside, I applaud her efforts to break down barriers to tests and to provide lower-costs, less invasive testing.

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