The Wall Street Journal reported last night that the company has told its regulator, the Centers for Medicare & Medicaid Services, that it has voided tens of thousands -- two years worth -- of patient blood test results. The tests were run on both the company's proprietary Edison machines and conventional testing equipment, the paper said. Some results were thrown out and some revised.
The Journal, which owns this story in a big way, cited its usual source: "a person familiar with the matter." Forcing Theranos to issue its usual confirmation, plus this statement:
"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 said in an email to KQED. "As these matters are currently under review, we have no further comment at this time."
If you've been following this story -- which has unfolded like some sort of Silicon Valley morality tale -- you know that Theranos made a splash with investors and the media by claiming it was going to remake the diagnostic testing industry with more efficient and cheaper blood tests. The company said it could sample just a finger-prick's worth of blood, collected in a device it called a "nanotainer;" that small amount of blood, the company claimed, was enough to run a host of tests. The FDA, however, approved the process for just one of those tests, and the company collects samples for all others the traditional way -- from a patient's vein.
In March, The Wall Street Journal reported Theranos had run tests measuring blood-clotting time on 81 patients despite erratic results from quality-control checks. Around the time the story came out, Theranos released a statement saying it had contacted any patients potentially affected by inaccurate tests.