The once $9-billion-valued Theranos appears to have admitted that its blood test data was faulty and is moving to restate two years of test results for 3 million patients.
The Wall Street Journal reported, and the company confirms, that Theranos told federal health regulators that the company voided and revised two years of results from its Edison blood-testing devices, and has issued tens of thousands of corrected reports to doctors and patients.
Breitbart News last October reported in “Silicon Valley: $9B Theranos Threatened with Extinction” that the company’s claims that its Edison test machines could generate hundreds of extremely accurate medical tests with just a minute amount of blood using high-tech nanotubes and microneedles might have been e completely fabricated.
At the time, Theranos was the darling of Silicon Valley, claiming that its miniaturized technology would be so cost effective it would crush such huge multi-billion dollar blood test leaders as Quest Diagnostics and LabCorp
But by April, the U.S. Attorney’s Office and Securities and Exchange Commission had launched criminal and civil investigations following reports that the Centers for Medicare & Medicaid Services were proposing to shutter both of Theranos’ labs and ban its fashionista founder Elizabeth Holmes from the medical testing business.
Despite receiving overwhelming adulation from former President Bill Clinton for creating one of the most revolutionary cost savers in healthcare, Theranos has now admitted that it had no effective proprietary technology for blood testing and that the company had thrown out all the tests conducted on its Edison in-house equipment in 2014 and 2015.
In a frightening admission for patients, Theranos told regulators that it used the Edison for only 12 types of tests out of the more than 200 test it offered to consumers, and then stopped using the Edison devices altogether in late June 2015.
It now appears that the company and its founder were aware that they were distributing erroneous patient test results in an effort to win FDA approvals and hype the stock value.
The Journal stated that the test allowed doctors to interpret the test in ways that would have caused improper treatments. If one death resulted, Theranos officers and directors will likely be subject to criminal prosecution.
By revising two years of test results with standard industry test equipment, Theranos is trying to persuade the Centers for Medicare & Medicaid Services to not shut down its labs and permanently ban the company from the medical testing business.
Theranos confirmed that it was using Edison machines to conduct 890,000 tests a year at its Newark, California lab.
Geoffrey Baird, associate professor in the department of laboratory medicine at the University of Washington in Seattle warned: “There have been massive recalls of single tests in the past, but I’m not aware of one where a company recalled the entirety of the results from its testing platform.”
Walgreens Inc., which has been a partner with Theranos since 2013, has been informed about the supposedly corrected blood test results issued to doctors and patients. Walgreens notified Theranos in January that it intends to terminate the partnership unless Theranos quickly puts itself back in compliance with federal regulations.
Theranos spokeswoman Brooke Buchanan said in response to the Journal‘s new allegations, “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.”