Brian Buntz

March 29, 2016

3 Min Read
More Questions about Accuracy of Theranos Tests

Theranos, already under fire from regulatory authorities at CMS and FDA, is facing renewed allegations that its blood-testing technology is inaccurate.

Qmed Staff

Elizabeth Holmes

Elizabeth Holmes is the CEO of Theranos. 

A recent study published in the Journal of Clinical Investigation (JCI) found that the company's fingertip-blood-testing technology could not match the accuracy of more conventional tests from LabCorp or Quest. "Theranos flagged tests outside their normal range 1.6× more often than other testing services (P < 0.0001)," the study concluded. "Of the 22 lab measurements evaluated, 15 (68%) showed significant interservice variability (P < 0.002). We found nonequivalent lipid panel test results between Theranos and other clinical services. Variability in testing services, sample collection times, and subjects markedly influenced lab results."

The tests were performed without the companies' knowledge.

The cholesterol tests carried out using Theranos technology differed sufficiently from the other labs' tests that they could affect physicians' ability to make medical decisions. The researchers concluded that the tests could lead physicians to "either inappropriately initiate or fail to appropriately initiate statin therapy" for some patients.

Also, Theranos technology did not provide results at all for 2.2% of the tests. The rate of non-results from the other two companies' technology was practically zero.  

Still, the results of the study were mixed and the Theranos results mostly agreed with more the results of traditional lab tests. But JCI concluded that "the disparities between testing services we observed could potentially alter clinical interpretation and health care utilization."

The company, which had received considerable accolades for the promise of its fingertip blood testing technology, has been the subject of mostly negative press attention after the Wall Street Journal published a series of scathing articles question its accuracy.

According to the New York Times, Theranos had sent a letter to the Journal last week attempting to block the publication of the study, arguing that the study was "flawed and inaccurate."

Theranos released a letter faulting the study for its reportedly "false and misleading statements."

Theranos states that "the authors informed the media that they reached out to Theranos regarding this study by email and that the authors received no response from Theranos." The letter goes on to say that none of its senior executives were contacted regarding the study.

Furthermore, the Theranos letter states that one of the authors of the study (EE Schadt) had a conflict of interest in that he works on the scientific advisory board of a firm known as NuMedii. Another author, Joel Dudley, has a more than 5% ownership stake in NuMedii according to Theranos. Furthermore, the Theranos letter goes on to criticize the study design and argue that the authors "fail to report how many finger pricks were performed at the first and second collection sites and whether or not they were on the same finger."

The recent study published in JCI was performed at the Icahn School of Medicine at Mount Sinai. The study was conducted in July 2015.

In all, 60 healthy adults participated in the study, which was carried out at two walk-in Theranos facilities in Arizona. 22 different variables were gauged in the study.

Learn more about cutting-edge medical devices at BIOMEDevice Boston, April 13-14, 2016.

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