Consumer health care company Theranos Inc. recently faced controversy since its blood tests may jeopardize patient health due to lack of accuracy. The company faces another ordeal as a new study raises questions about the accuracy of its blood tests.

In the study published in the Journal of Clinical Investigations, the researchers from Icahn School of Medicine at Mt. Sinai found that Theranos is more likely than conventional labs to return blood work with inaccurate numbers. This could lead to inappropriate treatments being prescribed by doctors because of faulty laboratory results.

The new study supports previous claims about the uncertainty of testing methods used and lack of scientific validation of the accuracy of results obtained from the company's blood tests.

When the researchers tested these on 60 patients, Theranos' finger-prick technology gave results outside the normal range 1.6 times more often than other testing services such as Quest Diagnostics Inc. and Laboratory Corp of America Holdings.

Theranos' rejected samples, which required blood be redrawn, were also higher than the two other companies.

"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," the researchers concluded.

"Greater transparency and evaluation of testing technologies would increase their utility in personalized health management," they added.

Needle-Free Blood Tests

Promising as it sounds, Theranos, a blood testing startup that has been valued at $9 billion, introduced needle-free blood tests. The company is known for its fingerprick blood tests that will generate results for several tests using only tiny samples of blood.

In late 2015, federal regulators initiated the investigation of complaints filed by two former Theranos employees. The investigation focused on the laboratory practices and research of the company. The company, which was dubbed a success by the many, was bombarded with series of reports questioning the credibility and accuracy of its tests.

Theranos' Response

The company, however, sent a letter to the Journal of Clinical Investigations.

"It is unfortunate that the authors of this study did not in fact contact Theranos, as this would have allowed the company to provide accurate and comprehensive data and input on the study design and procedures, all of which would have led to a more credible study," the letter said [PDF].

"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. It has produced a flawed and inaccurate study and we are disappointed that any journal would accept this study for publication," it added. 

Photo: Alden Chadwick | Flickr 

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