|Theranos' Palo Alto, CA, headquarters--Courtesy of Theranos|
Last month, Theranos, in an attempt to appease CMS, said it had issued tens of thousands of corrected test results and thrown out two years' worth of results from its Edison testing machines. But now, the Palo Alto, CA-based company has reversed itself, saying less than 1% of the blood test results it provided were voided or corrected.
The corrections and voided results were made out of "an abundance of caution," Theranos spokeswoman Brooke Buchanan said, as quoted by Bloomberg on June 3. The action followed a CMS letter, dated March 18, that threatened strict sanctions if the company didn't fix problems at its Newark, CA, facility--problems that had been flagged in a previous FDA report.
During an inspection of the lab, FDA officials found that Theranos' proprietary fingerprick blood-testing equipment was not up to the company's own accuracy requirements for a number of tests. The proposed sanctions included banning founder and CEO Elizabeth Holmes from the blood-testing business for at least two years and revoking Theranos' license for the lab in question. That's a long way to fall for a media darling that was once considered to have a rarified valuation exceeding $1 billion.
|A "nanotainer" blood collection device, which turned out to be an unapproved medical device--Courtesy of Theranos|
Theranos told Bloomberg that it has informed all patients affected by their revised or voided results and that it doesn't plan to send any more corrections. Yet, despite Theranos' assurances, some patients are hesitant to take the company at its word.
"It's such a big question mark, I'm not going to leave it to chance," Colin Jordan, of San Francisco, told Bloomberg. He got a blood panel and allergy test through Theranos last year. And while Theranos hasn't reached out with a report of erroneous results, Jordan's doctor has advised him to get the tests redone just in case.
Theranos has been criticized for failing to publish data for its tests in peer-reviewed journals. And while it has been saying since March that it will present data "in the coming months," John Ioannidis, a professor of medicine at Stanford University, remains unimpressed. "The mere fact that they retracted all these thousands of tests, this is extremely uncommon, and in a way it already proves that what they've been doing has failed," he said, as quoted by Bloomberg.
- read the Bloomberg story