Has the death knell sounded for Palo Alto, Calif.-based blood test startup Theranos?
After giving the company 10 days to resolve "deficient practices," some of which "pose immediate jeopardy to patient health and safety," CMS has granted it a one-week extension, according to BloombergBusiness. However, if Theranos is unable to address the issues, it could lose its certification and be subject to fines of up to $10,000 per day.
Theranos hired new lab director Kingshuk Das, MD, who will use the extra time to review the company's response, according to a statement provided to BloombergBusiness from Theranos spokeswoman Brooke Buchanan. CMS has said the extension is a "routine procedure in oversight of clinical labs," according to the report.
Once a tech darling, Theranos began to fall from grace after two investigative reports from The Wall Street Journal alleged the company overstated the capability of its product and the FDA pressured the company to stop using its proprietary finger-prick technology for all but one test. The company has said the WSJ reports were false and misleading, but since then has lost a $350 million deal with Safeway, trimmed its board by more than half and halted plans for expansion with Walgreens, before suspending use of all Theranos testing in Walgreens stores.
The company now has until Feb. 12 to submit a plan of correction, according to BloombergBusiness.
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