Theranos cholesterol test results called into question by Icahn School of Medicine study
Theranos calls study "flawed," denies that the authors had attempted to contact them regarding findings, letter says.
Elizabeth Holmes, Theranos CEO
Cholesterol test results obtained through Theranos Inc. were substantially different than those from large laboratory companies, implying that doctors' medical decisions could be thrown off by Theranos-acquired results, a study finds.
Conducted by researchers at the Icahn School of Medicine at Mount Sinai, the authors wrote that the abnormal test results "can have negative consequences for medicine in the form of extra testing, additional patient visits to clinics/hospitals, and added doctor services, all of which result in additional costs and burdens to patients or to the healthcare system."
Authors went on to say that the Theranos tests could be harmful if they lead to misdiagnoses, such as false positives.
[Also: Theranos signs with AmeriHealth, brings tests to Medicaid patients]
In all, Theranos' results for total cholesterol were found to be an average of 9.3 percent lower than those obtained through clinical laboratories Quest and LabCorp. This has lead researchers to surmise that in some instances, doctors may inappropriately begin, or fail to begin, statin therapy, a drug-based regimen that aims to prevent heart disease.
"The disparities between testing services … could potentially alter clinical interpretation and healthcare utilization," authors wrote. "Greater transparency and evaluation of testing technologies would increase their utility in personalized health management."
Theranos tests are widely available to consumers at Walgreens drugstores.
[Also: Theranos strikes deal with Capital BlueCross, lands on East Coast]
According to published reports, scientists have pressured Theranos to publish peer-reviewed data to support the accuracy of its blood tests, which rely on finger-pricking. The company said in October that it would publish relevant data, but to date has not.
A federal inspection of the company's lab in Newark, California in January found deficiencies that put the lab at risk of losing its federal certification if not resolved, reports say. In reaction, Walgreens shut down one of Theranos' clinics, and the drugstore is now reportedly trying to terminate its agreement with the startup, which has been valued at around $9 billion.
Attempts to contact Theranos were unsuccessful.
In a March 24 letter to the Journal of Clinical Investigation, representatives of Theranos, who had read a draft copy of the study, claimed it contained "false and misleading statements."
[Also: See what Theranos actually charges for tests (list)]
In the letter, Theranos denied that the authors had attempted to contact them regarding the study findings, claiming "the authors are making false claims to the media to inappropriately bolster their credibility and that of their study."
"It has produced a flawed and inaccurate study and we are disappointed that any journal would accept this study for publication," wrote Theranos. The company also criticized several of the researcher's methods, claiming that the study was deliberately designed to circumvent Theranos' standard blood collection procedures.
"We do not believe that the actions of the authors present a sound or scientific way to engage with us about the efficacy of our technologies," they wrote.
Twitter: @JELagasse
