Void blood test reportedly sent patient to emergency room in the US
Two years' worth of blood tests retracted by medical lab services company facing a criminal probe
Troubled start-up Theranos has voided some two years' worth of blood-test results from its flagship Edison machines, reports The Wall Street Journal.
The company has issued "tens of thousands" of corrected blood-test reports as a result.
The Edison machines are Theranos' main claim to fame. CEO Elizabeth Holmes rose to prominence on the huge promise that, with Edison, Theranos can test for blood-borne diseases with only a pinprick of blood from a fingertip.
But amid larger concerns over the accuracy and viability of the Edison technology, Theranos has told federal regulators that it's thrown out all results from 2014 and 2015.
That includes tests that Theranos did with Edison, as well as the ones it performed with traditional lab equipment, according to The Journal's report. That means that anybody who got a Theranos blood test during that period may have gotten wrong results.
The Journal report indicates that physicians in Phoenix have gotten corrected results from Theranos in recent weeks. In fact, one patient went to the emergency room in 2014 based on a Theranos blood-test result, says the report — a result that's now been amended.
The move to throw the test results out is a sign that Theranos is trying to show government agencies that it can regulate its own shortcomings. That's important because Theranos is facing a criminal investigation and it's trying to prevent further problems.
A Theranos representative said in a statement that patient safety and "excellence in quality" is a top priority.
"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," the company said, referring to the US Centers for Medicare and Medicaid Services.