Theranos Issues Thousands of Corrected or Voided Test Results

By Ron Shinkman, Editor, Laboratory Industry Report

While Theranos initially set out to change the laboratory sector with its Edison testing platform, to date it has mostly changed its test results.

The California-based startup has apparently invalidated tests performed on the platform between 2014 and 2015, the Wall Street Journal has reported. It has either voided or revised the results of tens of thousands of tests.

According to the newspaper, the move by Theranos may be part of a series of changes it is undertaking to keep its laboratory in the Northern California city of Newark credentialed by the Centers for Medicare & Medicaid Services. The company has halted most testing at the lab, hired a compliance officer, and recently appointed to its board of directors a physician with significant compliance and quality control experience in the pharmaceutical industry.

The CMS had previously said the laboratory’s ongoing operation placed patients in immediate jeopardy, and further rebuked Theranos for lack of corrective actions. It recently recommended that both company founder and Chief Executive Officer Elizabeth Holmes and President Sunny Balwani be banned from the laboratory business for a minimum of two years. The latter departed the company earlier this month, although Theranos did not say it was linked to its current compliance issues.

According to the Wall Street Journal, many of the corrected test results were sent to medical practices in the Phoenix, Ariz. area, where Theranos operates a number of walk-in test facilities in conjunction with Walgreens. At least one patient had been sent to a hospital emergency room due to incorrect test results furnished by Theranos, the newspaper said.

Theranos owns another lab in Arizona that was not cited by regulators and continues to operate, although the newspaper said some corrected blood coagulation tests were performed on a legacy Siemens device that had been improperly calibrated.

A more extensive report on the developments will appear in the next issue of Laboratory Industry Report.