|Theranos' Palo Alto, CA, headquarters--Courtesy of Theranos|
Theranos is in deep trouble with federal health regulators, and it's pulling out all the stops to get back in their good graces. The company threw out two years of results from its Edison devices, the controversial linchpin behind its proprietary blood testing technology.
Theranos told the Centers for Medicare and Medicaid Services (CMS) that it voided Edison test results from 2014 and 2015. The beleaguered company has also issued tens of thousands of corrected blood test reports to doctors and patients, a person familiar with the matter told The Wall Street Journal. Corrected reports include voided Edison results and some tests run on traditional lab machines.
The company's move comes as it tries to avoid strict sanctions threatened by CMS stemming from an earlier inspection of its Newark, CA-based lab. Last year, the agency stopped by to inspect the facility and found that Edison machines in the lab often did not meet Theranos' own accuracy standards. Internal records reviewed during the inspection show that the company's lab ran about 890,000 tests a year, the WSJ reports.
Theranos said it would try to get things back on track, but CMS wasn't satisfied with its response. In March, the agency proposed banning CEO Elizabeth Holmes from the company for at least two years. Regulators also threatened to yank the lab license for Theranos' Newark lab and impose fines against the company.
CMS is expected to announce a final decision on the sanctions soon, according to the WSJ story. Theranos could appeal, but it would face a long road ahead if it chose to do so.
The agency's proposed penalties are some of the most severe in its power, Sidley Austin Lawyer Barbara Cammarata told the WSJ last month, which could spell out big trouble for Theranos. "They're in a lot of trouble," Cammarata said.
But Theranos is keeping a stiff upper lip. "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," Theranos spokeswoman Brooke Buchanan told the newspaper.
- read the WSJ story (sub. req.)