Theranos under federal investigation in California, Bloomberg reports
Probes comes a week after the Centers for Medicare and Medicaid Services proposed banning CEO Elizabeth Holmes from the industry.
Blood testing startup Theranos is under investigation by the U.S. Securities and Exchange Commission and the U.S. Attorney's Office for the Northern District of California, according to a story first reported in Bloomberg.
The investigation is the latest in a series of hardships for the already besieged company, coming on the heels of a recommendation by The Centers for Medicare and Medicaid Services that founder Elizabeth Holmes be banned from the blood testing business for a two-year period.
In March, a study in the Journal of Clinical Investigation found that cholesterol test results obtained through Theranos -- which are drawn from small finger pricks -- were much different than those from large laboratory companies, implying that doctors' medical decisions could be thrown off by results acquired through Theranos technology.
[Also: CMS may ban Theranos founder Elizabeth Holmes for 2 years, sanction company]
In all, Theranos' results for total cholesterol were found to be an average 9.3 percent lower than those obtained through clinical laboratories Quest and LabCorp, according to the March study. This has lead researchers to surmise that in some instances, doctors may inappropriately begin, or fail to begin, statin therapy, a drug-based regimen that aims to prevent heart disease.
Before the federal investigations were announced Monday, Holmes appeared on NBC's "Today" show to say she was "devastated" that her lab did not discover its deficiencies. Holmes also said Theranos would rebuild its lab from scratch to avoid future problems.
In addition to suggesting that Holmes be temporarily banned from the industry, CMS has proposed a number of other sanctions, including revocation of Theranos' Clinical Laboratory Improvement Amendments of 1988 certificate -- or alternatively, a civil monetary penalty of $10,000 per day for each day of non-compliance. Theranos could delay the effective date of the sanctions by filing an appeal.
Twitter: @JELagasse
