Blood-testing firm Theranos has voided two years' worth of results obtained using its Edison platform and has sent tens of thousands of corrected reports to doctors and patients, the Wall Street Journal reports.
This move, the Journal adds, comes after federal regulators uncovered a number of deficiencies at the company's California lab during an inspection and then, after finding the company's plan of corrective action lacking, threatened to bar CEO Elizabeth Holmes and president Sunny Balwani from owning or operating any lab for two years. Balwani stepped down last week.
The company now has informed regulators at the Centers for Medicare & Medicaid Services that it threw out all Edison-based results from 2014 and 2015, and the Journal notes that a number of physicians in the Phoenix area confirmed receiving voided or revised reports from Theranos.
"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 Brooke Buchanan tells the WSJ. "As these matters are currently under review, we have no further comment at this time."
One physician tells the paper that a revised report she received was for a patient whose initial Theranos test indicated an abnormal result, so much so that she sent the patient to the emergency room. The new report places the patient in the normal range.
Some of the revised results also came from tests run on platforms other than Edison, the Journal adds. A source tells the WSJ that a traditional lab machine from Siemens had been set incorrectly by Theranos and that Theranos didn't take the purity of the water used in the machines into account, as it should.