Theranos Limits Use of Blood Test Technology

October 16, 2015

Theranos, the clinical lab company revolutionizing its industry with low-cost finger-prick tests, is limiting the use of its tiny blood vials to assays approved by the US Food and Drug Administration (FDA), company CEO Elizabeth Holmes said yesterday.

Of the 250-plus tests that Theranos performs, only one — for herpes simplex virus-1 immunoglobulin G — is FDA-approved. But more tests are in the regulatory pipeline.

The 31-year-old Holmes revealed this state of affairs to CNBC reporter Jim Cramer on Thursday as she responded to a Wall Street Journal article published earlier that day that suggested the Theranos in-house lab instrument called Edison was often inaccurate.

Theranos has characterized the WSJ article as ""factually and scientifically erroneous"" as well as grounded on "baseless assertions" by disgruntled, inexperienced employees and jealous industry rivals. Furthermore, the WSJ turned a blind eye to ample evidence from Theranos that exonerated its technology, according to a news release the company issued yesterday.

In a follow-up story, the WSJ reported that Theranos recently stopped collecting finger-prick blood samples in its patented Nanotainer vials except in its herpes simplex test after the FDA conducted a surprise inspection and declared the vials to be unapproved medical devices. The FDA approval of the Theranos test for herpes simplex, in contrast, included the Nanotainer.

An FDA spokesperson told Medscape Medical News that she could not comment on whether the agency had cracked down on Theranos as reported.

Laboratory Developed Tests in the Spotlight

The FDA has indicated publicly that it seeks to more tightly regulate in vitro tests used by the likes of Theranos. In vitro diagnostic tests that manufacturers sell to end users, such as clinical labs or patients, must be FDA-approved. But what Theranos relies on are "laboratory developed tests" (LDTs), which are designed, manufactured, and used in-house. Traditionally, the FDA has not required LDTs to obtain FDA approval — an example of "enforcement discretion" — because they were relatively simple tests and not widely available.

However, LDTs have "proliferated significantly" since the FDA gained authority to regulate all in vitro tests as medical devices in 1976, the agency states on its website. In addition, more complex LDTs on the scene diagnose conditions such as cancer and Alzheimer's disease, not just a patient's vitamin levels. When such higher-risk LDTs make a mistake, patients can suffer serious if not deadly consequences.

Without naming names, the FDA points to problems with several higher-risk LDTs, which include "claims that are not adequately supported with evidence, lack of appropriate controls yielding erroneous results, and falsification of data." Accordingly, the FDA has proposed that high-risker LDTs must secure agency approval after a premarket review and all the testing that comes with it.

In contrast, the Theranos assay for herpes simplex won approval in July through the agency's 510(k) process, which requires a manufacturer to demonstrate only that its product is substantially the same as one already on the market.

Theranos has said repeatedly that it advocates for FDA regulation of LDTs, so much so that it voluntarily sought agency approval of the herpes simplex test even though it didn't need to. In yesterday's news release, the company said the FDA decision validated "the very proprietary systems the [WSJ] story is asserting don't work." It has submitted nearly 130 more LDTs to the FDA for its blessing.

A company news release issued Friday went further, explaining that after winning approval for the Nanotainer and the rest of its testing technology for herpes simplex, Theranos intends to get the Nanotainer cleared for all the other tests.

"That means temporarily using a different tube — tubes for venous blood — so we can maintain the quality standards we have in our labs as we complete the clearance process of the Nanotainer," the company said. "Still smaller tubes, smaller samples, lower costs."

Medscape Medical News did not receive a response to an interview request from Theranos.

"This Is What Happens When You Work to Change Things"

The question of whether the FDA should regulate LDTs is a hot topic in Congress, said Diana Zuckerman, PhD, president of the National Center for Health Research, a think tank focused on both children and adults, in an interview with Medscape Medical News. Some lawmakers, said Dr Zuckerman, believe excessive regulation is discouraging innovation. Others fear laxity that will permit unsafe, ineffective products to reach the market. Dr Zuckerman favors a more cautious approach to LDTs.

"There's so much excitement about these tests, but the scientific evidence of how well they work is lacking," said Dr Zuckerman.

In her interview with Jim Cramer on CNBC, Theranos' Holmes said the current dust-up is the price one pays for being a pioneer.

"This is what happens when you work to change things," she said, wearing her trademark black turtleneck on the air. "First they think you're crazy, and then they fight you, and then all of a sudden you change the world."

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