Theranos slammed again after new study points to testing flaws

Eric Schadt

Just when it seemed like things couldn't get much worse for Theranos, they did. The company's blood tests turned up irregular results more often than products from rivals Quest Diagnostics ($DGX) and LabCorp ($LH), researchers found in the first published independent study of Theranos' tests.

Scientists at the Icahn School of Medicine at Mount Sinai saw that the Palo Alto, CA-based company's finger-prick technology rejected samples 2.2% of the time when tested on 60 patients. The same thing never happened with Quest and LabCorp's products.

Theranos' test results also fell outside of the normal range more often than its competitors'. The company's tests were outside of the normal range 12.2% of the time, compared to 8.3% for LabCorp and 7.5% for Quest, according to results published Monday in the Journal of Clinical Investigation (JCI). The study, which was conducted in July before Theranos' testing fallout, collected samples for 22 measures including cholesterol.

Researchers did not pin all the study discrepancies on Theranos, though. Quest and LabCorp also had different numbers in some cases. "There's actually pretty widespread variability in these clinical measures, even between reference labs," Eric Schadt, chairman of genetics and genomic sciences at the Icahn School and a lead author of the study, told The New York Times. "But Theranos was more outside of range and outside of range in ways that would impact clinical decision-making."

Unsurprisingly, Theranos is standing by its tests. The company has "significant concerns regarding the study's methods and conclusions," Theranos wrote in a letter to JCI, as seen by Bloomberg. Researchers collected finger-prick samples after drawing blood from a person's veins, which can skew results, Daniel Young, Theranos' lab director, told the news outlet. And the journal should not publish the scientists' findings, the company argued in its letter. 

But some lab experts have a different opinion. "This represents just another effort for a failing company to cover up bad press for a technology that is not ready for prime time," Dr. Frederick Kiechle, medical director for clinical pathology at Hollywood, FL-based Memorial Healthcare System, said about Theranos' letter to JCI, as quoted by the NYT.

The study results do nothing to help Theranos, which is struggling under the weight of its recent testing fallout. Last year, articles published in The Wall Street Journal pointed to flaws in the company's proprietary testing technology. Theranos stopped collecting finger-prick blood samples for all but one of its more than 200 tests after the FDA found that "nanotainers" made and used by the company were uncleared medical devices. Another story showed that Theranos' lab tool only handled a small portion of tests sold to consumers.

In the latest chapter of the company's fall from grace, the Centers for Medicare and Medicaid Services (CMS) chastised Theranos for issues at its Newark, CA-based lab. The agency cited the company for "deficient practices" at the facility, including an infraction that poses "immediate jeopardy to patient health and safety."

Now, Theranos is trying to deal with the aftermath. The company has come under fire for not publishing data for its tests in peer-reviewed journals, but Theranos plans to publish studies "in the coming months," spokeswoman Brooke Buchanan told Bloomberg. And the embattled testing startup has held research round tables with top experts over the past 3 months, Buchanan said, as it attempts to get back in the good graces of the public and its partners.

- here's the JCI study
- read the Bloomberg story
- get more from the NYT (sub. req.)

Special Report: The most influential people in biopharma today - Elizabeth Holmes - Theranos

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