Theranos lab poses 'immediate jeopardy' to patients, say regulators
A California startup offering easy and inexpensive blood tests to help people check themselves for STIs, celiac disease or high cholesterol levels has again run afoul of federal lab regulators.
It’s the latest public blow for the formerly high-flying Theranos of Palo Alto, Calif., which in September “voluntarily paused” the use of its specialized finger-prick blood draws. The finger-prick draws, and the tiny containers the blood was sent away for testing in, were a key component of the company’s model to make blood-testing cheaper and more widely available. The company is now using more standard blood draws of the kind performed by phlebotomists in clinics or hospitals.
In November, the privately held company led by Elizabeth Holmes was valued at $9 billion.
Theranos' Holmes promises more transparency
In a letter sent to Theranos earlier this week, federal officials from the Centers of Medicare & Medicaid Services said they found multiple problems with the company’s Newark, Calif. lab and ordered changes. Lab regulators raised similar concerns about the company’s Scottsdale, Ariz. lab last spring.
“In addition … it was determined that the deficient practices of the laboratory pose immediate jeopardy to patient health and safety,” the CMMS inspectors wrote in a Jan. 25 letter warning Theranos that it could face sanctions if didn’t fix the problems.
In a statement, a Theranos spokeswoman said the company has hired a new lab director and clinical consultant, and has already addressed many of the concerns raised by the inspection.
"We value engagement with our regulators, which helps us build best-in-class systems, and are committed to ensuring that all our labs operate at the highest standards,” wrote Brooke Buchanan, a company vice president.
Buchanan said the company hopes to resume use of the finger-prick tests once the FDA finishes its review process. And she said that 90% of tests are currently being performed at the Scottsdale lab, which meets federal standards.