Theranos Turns to Silence as Controversy Unfolds

The curious case of Theranos raises questions not only about the former media darling but also about the rules that allowed it to share so little data with government regulators.

Nancy Crotti

The $9-billion Silicon Valley startup that promised to perform multiple diagnostic tests with a single drop of blood has gone silent after receiving scrutiny from FDA, the Wall Street Journal, and other media outlets. The Journal questioned the accuracy of the firm's trademark finger-prick blood tests and, in its most recent article, reported that the firm has stopped using them for all but a single test.

Immediately following that news last week, the company went on the offensive, having their CEO appear on Mad Money and releasing statements on its website and over Twitter.

But it has been radio silence from the company since Friday, leaving outlets and commentators to fill the void, demanding more answers from the firm, some of them speculating that the WSJ article may prove fatal for the company. "Theranos' story could end with the Wall Street Journal," says Wired.

Business Insider reports that Google Ventures passed on investing in the company. "So, we just had someone from our life-science investment team go into Walgreens and take the test," says Google Ventures investor Bill Maris. "And it wasn't that difficult for anyone to determine that things may not be what they seem here."

Theranos founder Elizabeth Holmes has insisted that the company's technology is accurate, even revolutionary, and criticized the WSJ for using unnamed former Theranos employees as sources.

Now wired.com has published a story directing attention to the federal rules that allow labs to "effectively police their own tests."

The Clinical Laboratory Improvement Amendments (CLIA) were enacted to offset government safety regulation with laboratory-based innovation. "CLIA exists for patient safety. But it also exists so labs can churn out new tests as fast as they can think of them," the Wired story says. "Rather than review every single test, the rules essentially review the lab."

CLIA provides for the Department of Health and Human Services to issue a "complexity rating" for each new lab test, in gradations from "highly complex" to "waived," according to Wired. Theranos has sought "waived" status for all of its tests, and won it for its herpes simplex I test.

Waived status would have allowed Theranos to make a lot of money on consumer-friendly lab tests, available inexpensively at Walgreens, mostly in Arizona.

Having FDA review the use of the Nanotainer is part of a broader move by Theranos to transition completely to using FDA standards guiding laboratory developed tests (LDTs) in CLIA-certified laboratories. The company says that its dealings with FDA, which include sharing price and product data, represents "unprecedented transparency."

Theranos' assertion that it can run hundreds of tests from a single drop of blood has raised numerous eyebrows in the medical community. Now, longtime techie and blogger Jean-Louis Gasse?e has done a head-to-head challenge, pitting his own test results from a university laboratory against those from a Theranos test performed in a California Walgreens.

In his Monday Note blog, Gasse?e notes that  complete blood counts taken one hour apart at Stanford University's hematology lab and at the Walgreens yielded disparate results, particularly for platelet count. A note to Holmes detailing those results yielded no response, according to Gasse?e.

The company also did not immediately respond to a request for comment on the Wired story.

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