Theranos results differed from Quest, LabCorp enough to impact care decisions, study finds
A new study found that cholesterol tests performed by the startup Theranos were divergent enough from those done by more established laboratories that they could affect physicians' care decisions.
Published this week in the Journal of Clinical Investigation, the research from the Icahn School of Medicine at Mount Sinai focused on 22 common lab tests performed for 60 healthy adults over five days this past summer.
Theranos’ total cholesterol results were lower than those produced by lab test leaders Quest and LabCorp by a 9.3 percent on average – a variation significant enough that it could potentially influence whether or not doctors prescribe cholesterol medications for their patients.
"With intraindividual variations in LDL levels exceeding 20 mg/dl in several otherwise healthy subjects, a strong possibility remains that practitioners either inappropriately initiate or fail to appropriately initiate statin therapy due to interservice variations," Mount Sinai researchers write.
[Also: Practice Fusion inks deal with Theranos]
The new study – billed as the first comparison study with more traditional labs – is another unwelcome development for Theranos, which touts its simplified microfluidics technology, able to gain test results with just a finger prick, rather than the usual venipuncture.
Having raked in more than $800 million in venture cash and seen its valuation climb above $9 billion, the firm has had a rocky several months, beginning with an October 2015 Wall Street Journal report that its flagship Edison technology gives inaccurate results (and isn't even used for all of the tests it provides).
The U.S. Food and Drug Administration subsequently revealed its own misgivings about the Edison device. And more recently, on January 26 the Centers for Medicare and Medicaid Services said some of Theranos' practices posed "immediate jeopardy to patient safety," and threatened to suspend its certification under the Clinical Laboratory Improvement Amendments unless certain deficiencies were addressed,
In a letter to JCI about this new Mount Sinai study, Theranos fired back that the research is "flawed and inaccurate," charging, among other complaints, that one of the authors failed to note a potential conflict of interest.
"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," Theranos executives wrote in the letter.
For its part, the Mount Sinai research team concluded that the variability of Theranos' study results were significant, and called for more openness from a company long known for its relative secrecy.
"While laboratory practice standards exist to control this variability, the disparities between testing services we observed could potentially alter clinical interpretation and health care utilization," they wrote. "Greater transparency and evaluation of testing technologies would increase their utility in personalized health management."
Twitter: @MikeMiliardHITN
Email the writer: mike.miliard@himssmedia.com
