More Problems at Theranos

Excerpts from various media coverage regarding US regulators saying that a Theranos lab poses an “immediate jeopardy” to patient safety — and a statement from Theranos:

Forbes: Some Theranos Tests ‘Pose Immediate Jeopardy To Patient Health And Safety’
“A letter sent to Theranos by U.S. regulators says problems with the company’s blood tests “pose immediate jeopardy to patient health and safety.” Theranos says all the problems are being fixed. And keep in mind that regulators often amp up their language in these types of letters to pressure companies to comply. But there’s no way to paint the letter as a good thing. More than that, the letter also poses a new threat to Theranos, a company valued on private markets at more than $9 billion and led by a charismatic founder, Elizabeth Holmes.” Full article

Bloomberg: Theranos Lab Faults Jeopardized Patient Health, U.S. Says
“Theranos has 10 days to show CMS that it’s taking action immediately to fix the issues. If the lab doesn’t come into compliance, the government said it could impose sanctions on the company, including fines or on-site monitoring, or could revoke the company’s participation in government programs. CMS is tasked with monitoring most U.S. medical labs. The government specifically noted Theranos’s blood testing, which is the backbone of the startup’s technology. The agency said the “immediate jeopardy” referred to in the letter means that the problems cited with the blood tests are causing, or are likely to cause, “serious injury or harm, or death, to individuals served by the laboratory or to the health and safety of the general public.” Full article

New York Times: Theranos Lab May Pose Threat to Patient Safety, Regulator Says
“While Ms. Holmes has been insistent that the company will eventually win the necessary regulatory approvals, the letter from C.M.S. fosters continued skepticism over Theranos’s ability to perform these novel tests with a few drops of blood. In its letter, dated Jan. 25, C.M.S., which is the regulator responsible for overseeing clinical laboratories, detailed five conditions that it said the Newark lab failed to meet. The deficiencies involve oversight and personnel at the lab and the systems used to analyze the tests, the agency said.” Full article

Statement by Theranos on CMS Audit Results
“We received a report from CMS documenting their findings from a scheduled survey in our Newark, CA lab that took place last fall. In line with our commitment to leading the lab industry in transparency, we wanted you to hear directly from us regarding this survey and report: This survey of our Newark, CA lab began months ago and does not reflect the current state of the lab. As the survey took place we were simultaneously conducting a comprehensive review of our laboratory’s systems, processes and procedures to ensure that we have best-in-class quality systems. We value engagement with our regulators, and are committed to ensuring that all our labs operate at the highest standards. We are still reviewing the report, but we addressed many of the observations during the survey and are actively continuing to take corrective action. A full plan of correction will be submitted to CMS within days.” Full statement