Theranos could be offering inaccurate results with its blood testing devices: Analysis

Theranos, a California-based medical laboratory Service Company, shot to success after developing a blood testing device named Edison, which uses only a few drops of blood through a finger stick unlike conventional technique that takes vials of blood via venipuncture. The developer of Edison and founder of Theranos Elizabeth Holmes made millions through her invention. However, a recent federal report found deficiencies in Theranos blood testing devices.

The 121-page-long report was released on Thursday, according to which laboratory inspection done by the Centers for Medicare and Medicaid Services at Theranos’s laboratory in Newark, California, found faults in its quality control, which could have been failing at providing accurate results for patients. The company is blamed for using unqualified or inadequately trained personnel.

The report also suggests that Theranos stored samples in freezers that were not at the proper temperature. The company did not ensure the quality control for the blood-clotting test before declaring the results of the tests to patients. If the company fails to fix the current problems at its laboratory, Theranos can lose its certification.

It’s not the first time the question are raised on the quality of services provided by Theranos. Earlier this week, researchers at the Icahn School of Medicine at Mount Sinai published the first independent assessment of Theranos. They found that the blood testing company produces more irregular results than two more conventional laboratories.

In January, federal regulators had released a short report claiming many deficiencies at Theranos. One of the deficiencies even put a patient’s health at risk. The most recent report is more reliable as it includes inspection of testes from Theranos’s own internal testing.