Friday, October 16, 2015

240 Tests on a Drop of Blood. Too Good to be True?

When Theranos, a Pan Alto startup, announced it could perform 240 tests on a single drop of blood with a finger prick and report results within 15 minutes, it sounded revolutionary No more painful drawing of blood from veins. No more expensive tests from national labs. No more endless waiting for results.

Well as it turns out, the single prick single drop of blood as the basis for performing 240 tests may have been too good to be true. Critics, many former Theranos employers, say the tests may not only be inaccurate but most are outsourced to commercial labs rather than being done by an Theranos revolutionary technology known as Edison.

Startup investors, who have poured millions into Theranos, raising its market capitalization value to $9 billion will be disappointed.

The Federal Drug Administration has told Theranos to stop finger tip collections of blood until further notice and further investigation.

As a pathologist, I have always been skeptical of results produced on small or inadequate samples, whether these samples be on needle or aspiration biopsies or on single drops of blood. One needs an adequate sample to make an adequate diagnosis.

Blood-Testing Startup Theranos Halts Most Finger-Prick Collections After FDA Pressure

In most of its tests, the company has stopped collecting blood drawn from the finger in tiny vials, or “nanotainers,” that the Food and Drug Administration considers to be unapproved devices. Theranos says its services are "accurate and reliable."

The Wall Street Journal: Hot Startup Theranos Dials Back Lab Tests At FDA’s Behest

Under pressure from regulators, laboratory firm Theranos Inc. has stopped collecting tiny vials of blood drawn from finger pricks for all but one of its tests, according to a person familiar with the matter, backing away from a method the company has touted as it rose to become one of Silicon Valley’s hottest startups. (Carreyrou, (10/15)

Bloomberg: Theranos Disputes Report, Says Tests Are 'Accurate And Reliable'

Silicon Valley blood-testing startup Theranos Inc., responding to an article in the Wall Street Journal that questioned its technology, said its products and services are "accurate and reliable." The Journal article said that the company overstated the ability of its tests to accurately perform several dozen types of measurements and that Theranos relied on other companies’ equipment for many tests. While the newspaper was working on the story, Theranos removed language from its website that said, "Many of our tests require only a few drops of blood," according to the article. Theranos told the newspaper it made those changes for marketing accuracy. (Mittleman, 10/15)

USA Today: Bloodwork Darling Theranos Under Fire
Theranos, the secretive and revolutionary bloodwork analysis start-up valued at $9 billion, is under fire from a Wall Street Journal report that anonymously quotes former employees who question the efficacy and accuracy of the company's proprietary hardware. The heart of the allegations charge that of the 240 different tests Theranos offers consumers, only 15 are conducted on a machine called Edison while the rest are being outsourced to machines that are similar to those used by more traditional labs such as LabCorp and Quest Diagnostics. (della Cava, 10/15)

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