Theranos has voided two years of results from its Edison blood-testing machines, issuing tens of thousands of corrected reports to patients and doctors and raising the possibility that many health care decisions may have been made based on inaccurate data. The Wall Street Journal first reported the news, saying that many of the corrected tests have been run using traditional machinery. One doctor told the Journal that she sent a patient to the emergency room after seeing abnormal results from a Theranos test; the corrected report returned normal readings.
Theranos has informed regulators at the Centers for Medicare and Medicaid Services of the voided results. "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," Theranos spokesperson Brook Buchanan told the Journal. "As these matters are currently under review, we have no further comment at this time."
The proprietary Edison machine was seen as one of the key inventions leading to Theranos' $9 billion valuation; the device was said to be able to perform a range of diagnostic tests from a single finger prick of blood. Theranos reportedly stopped using the machines last June. Heather King, the company's general counsel, said in October that Theranos had no indication that "inaccurate results were returned to patients" following the Journal's initial exposé.