CMS letter to Theranos claims test failed to spot prostate cancer
Former employees claim that finger-prick blood samples were diluted to fit the machine's volume requirements.
Earlier this month, CMS had proposed a number of different sanctions, including banning Theranos founder Elizabeth Holmes from the blood-testing business for at least two years.
The Centers for Medicare and Medicaid Services has made public a "lightly redacted" copy of the letter it sent to beleaguered blood-testing company Theranos on March 18, with newly revealed allegations that its proprietary testing devices often failed to meet the company's own accuracy requirements for certain tests -- in one instance, failing to accurately detect prostate cancer.
CMS has also released a lightly redacted copy of the inspection report culled from the agency's visit to Theranos' California lab during the fall of 2015.
[Also: Theranos under federal investigation in California, Bloomberg reports]
The inspection report calls into question the efficacy of a traditional blood-testing machine from Siemens that Theranos used to run tests, with former employees claiming that finger-prick blood samples were diluted to fit the machine's volume requirements, an allegation which Theranos has denied.
Earlier this month, CMS had proposed a number of different sanctions, including banning Theranos founder Elizabeth Holmes from the blood-testing business for at least two years. Other recommendations included the revocation of the company's Clinical Laboratory Improvement Amendments of 1988 certificate, or alternatively, a civil monetary penalty of $10,000 per day for each day of non-compliance.
[Also: CMS may ban Theranos founder Elizabeth Holmes for 2 years, sanction company, WSJ says]
For now, those sanctions are on hold while Theranos is given the chance to take corrective measures, according to published reports.
The company's woes kicked into overdrive in March, when a study in the Journal of Clinical Investigation found that cholesterol test results obtained through Theranos were found to be an average of 9.3 percent lower than those obtained through clinical laboratories Quest and LabCorp, stoking fears that some patients would begin, or fail to begin, important therapeutic treatments.
Twitter: @JELagasse
