Theranos Questions Findings That Cast a Shadow on its Tests

Theranos is fighting back against study findings critical of the reliability of some of the company’s finger prick blood tests.

In a March 24 letter, the company says there are “major problems” in findings published in the Journal of Clinical Investigation that questioned the reliability of Theranos’ medical tests.

The study, which was funded by Icahn Institute for Genomics and Multiscale Biology and the Harris Center for Precision Wellness at the Icahn School of Medicine at Mount Sinai, examined 60 individuals whose blood was collected either by Theranos’ finger prick system or traditional venipuncture, followed by testing by Quest Diagnostics and LabCorp. The assessment took place between July 27 and July 31, 2015.

According to the findings, Theranos flagged abnormal test results roughly 1.5 times more often than its competitors, something that could cause patient harm.

The study highlights a difference in total cholesterol results between Theranos and the other two labs, with the startup reporting 9.3 percent lower levels, on average.

“While most of the variability we found was within clinically accepted ranges, there were several cases where inaccurate results would have led to incorrect medical decisions,” said Joel Dudley, senior author and Director of Biomedical Informatics at the Icahn School of Medicine at Mount Sinai.

‘Flawed and Inaccurate’

Theranos officials were quick to find fault with the study findings, calling them “flawed and inaccurate” in its missive to JCI, adding, “We are disappointed that any journal would accept this study for publication.”

The company also said that one of the authors failed to disclose that he sat on the scientific advisory board of potential Theranos rival NuMedii — something that could represent a conflict of interest.

Once a darling of the startup world, Theranos has faced intense scrutiny in recent months. For example, it was hit with two 483s, one of which took the company to task for shipping an uncleared device (IDDM, Oct. 30, 2015).

In January, the Centers for Medicare & Medicaid Services sent Theranos a letter detailing several deficiencies at its Newark, Calif., laboratory, following a Nov. 20, 2015, onsite survey (IDDM, Jan. 29). In early March, the company responded to CMS’s findings with a plan of correction and related evidence, detailing how it is addressing the issues.

Read the study here: www.jci.org/articles/view/86318. — Jonathon Shacat