Theranos CEO and Founder Elizabeth Holmes.
After federal regulators threatened to revoke Theranos’ license to conduct blood tests and ban its CEO and COO from the industry altogether, the company reportedly issued tens of thousands of corrections to its blood tests. Theranos has also invalidated all 2014 and 2015 results from its once famous Edison blood test machines, according to the Wall Street Journal.
The Edison machines, which reportedly could perform more than 200 medical tests with just a few drops of blood, were key to the fledgling biotech making a whopping $9 billion in 2014. machines were inaccurate and unreliable, and that workers were not qualified and did not follow proper protocols and fail to resolve issues, the company acknowledged that it had completely stopped using the devices in June 2015. Instead, the company conducted its blood tests — 890,000 blood tests per year, according to data — on standard lab equipment.
The corrections and invalid results cause clinics and doctor’s offices to receive piles of notifications. One such doctor’s office, a family physician in a suburb of Phoenix, told the WSJ that she received 20 corrected reports a few weeks ago. One of those corrected reports was for a patient the doctor sent directly to the emergency room after receiving her Theranos results in late 2014. The corrected report shows that the patient had normal results.
The unprecedented number of corrected lab results is just one of the steps Theranos is taking to try to appease the Centers for Medicare and Medicaid Services, which in March threatened to revoke the company’s license and expel CEO and founder Elizabeth Holmes, and its president and Ban COO , Sunny Balwani, from blood tests.
Theranos has since hired new clinical lab consultants and it was announced last week that Balwani will be leaving the company. Meanwhile, Holmes has publicly stated that she is “devastated” by the events, but takes full responsibility and will resolve the issues at the beleaguered company.
In addition to potential sanctions from the CMS, Theranos is also under criminal investigation by the Securities and Exchange Commission and the U.S. Attorney in San Francisco for allegedly misleading investors and regulators about the performance of its Edison devices.
Nevertheless, Theranos is preparing to open a new lab in Harrisburg, Pennsylvania, equipped with standard blood testing machines.