Troubled bio-tech startup Theranos has told the Centers for Medicare and Medicaid Services (CMS) it voided two years of results from the blood tests that it once staked its future on, reports the Wall Street Journal. All results taken from its Edison blood-testing devices in 2014 and 2015 were thrown out and updated reports sent to doctors.
The Edison blood test was considered disruptive because it relied on just a drop of blood from a finger prick, and was one of the main reasons the startup achieved a $9 billion valuation in 2014.
According to the WSJ, Theranos also told the CMS—which is currently investigating the startup for compliance issues—that it has issued tens of thousands of corrected blood test reports to doctors and patients, with some results voided and others revised.
These reports include data from both Edison devices and traditional lab machines.
In an emailed statement, Theranos spokesperson Brooke Buchanan said, “Excellence in quality and patient safety is our top priority and we’ve taken comprehensive corrective measures to address the issues CMS raised in their observations. As these matters are currently under review, we have no further comment at this time.”
TechCrunch has also contacted the CMS for comment.
Tossing out reports and issuing thousands of new ones is one of the biggest steps Theranos has taken as it tries to avoid sanctions from the CMS. Unfortunately, it also means that health providers and patients relying on the voided tests may have made faulty medical decisions. The WSJ spoke to several doctors near Phoenix, Arizona who said they had received corrected reports, including one physician who sent a patient to the emergency room based on erroneous results from Theranos.
The CMS is just one of several federal agencies currently investigating Theranos for issues connected to its diagnostic tests and business operations. The CMS investigation revolves around compliance issues at Theranos’ main lab in Newark, California and may result in a two-year suspension from owning or running a lab for Elizabeth Holmes, the company’s founder, and Sunny Balwani, its former president. Balwani left the company earlier this month.