Theranos has withdrawn the results of all blood tests run on its Edison device in 2014 and 2015, The Wall Street Journal reported Wednesday, citing a person familiar with the matter.
According to the report, Theranos has informed the Centers for Medicare and Medicaid Services of its decision to issue corrected blood-test reports to doctors and patients, canceling the results in some cases and revising others.
Theranos' reputation has been based on providing fast, accurate and affordable blood testing, using its Edison machine, which employs smaller needles and tubes than traditional blood-testing devices.
But the company, valued at more than $9 billion, has come under scrutiny after media reports questioned the accuracy of the proprietary test methods.
A particular blood-coagulation test was deemed in January by the Centers for Medicare and Medicaid Service to put patients in "immediate jeopardy," according to the WSJ report.
According to the WSJ, Theranos' latest move was aimed at convincing the agency to not impose strict sanctions.
"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," a Theranos spokesperson said in response to the WSJ report.
You can read the full WSJ report here
- Anita Balakrishnan contributed to this article