CMS: Theranos’ Practices Pose ‘Immediate Jeopardy’ To Patient Health
The Centers for Medicare & Medicaid Services has threatened the blood testing startup with sanctions if it does not address the issues.
The New York Times: Theranos Lab May Pose Threat To Patient Safety, Regulator Says A federal regulator has found that a lab run by Theranos, the Silicon Valley laboratory that promised to perform blood tests with a simple finger stick, violated several clinical standards, including one it said posed a threat to patient safety that had to be immediately corrected. The regulator, the Centers for Medicare and Medicaid Services, conducted an inspection of the company’s Newark, Calif., laboratory last year, but it issued a letter this week detailing the violations and raising the possibility that Theranos could lose certification for the lab in question. (Abelson, 1/27)
Bloomberg: Theranos Lab Faults Jeopardized Patient Health, U.S. Says U.S. regulators found serious shortcomings at a medical laboratory run by startup Theranos Inc., the latest in a series of setbacks for the highly valued blood testing startup founded by billionaire entrepreneur Elizabeth Holmes. Deficiencies at Theranos’s lab in Newark, California, “pose immediate jeopardy to patient health and safety,” U.S. government regulators said in a letter to the company released Wednesday that demanded immediate changes at the lab and threatened the closely held company with sanctions. (Tracer and Chen, 1/27)
The Wall Street Journal: Theranos Lab Practices Pose Risk to Patient Health, Regulators Say [The Centers for Medicare and Medicaid Services] defined one infraction by the blood-testing company, based in Palo Alto, Calif., as a situation “likely to cause, at any time, serious injury or harm, or death, to individuals served by the laboratory or to the health and safety of the general public.” If the lab doesn’t correct them and come back into compliance, CMS could revoke the facility’s certification to test human specimens and fine Theranos as much as $10,000 a day, according to the letter. (Carreyrou, 1/27)
The Associated Press: Regulators Warn Testing Startup Theranos Over Lab Conditions Federal regulators have issued a warning to blood-testing startup Theranos, saying some of the Silicon Valley company’s testing procedures do not meet standards designed to protect patients. Inspectors for the Centers for Medicare and Medicaid Services sent a letter to Theranos, citing five deficiencies at a laboratory run by the privately held company. In the Jan. 25 letter, inspectors say that some of the problems “pose immediate jeopardy to patient health and safety.” (1/27)
USA Today: 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. (Hughes, 1/27)
The Washington Post’s Wonkblog: Deficiencies At Theranos ‘Pose Immediate Jeopardy To Patient Health’ Theranos, once valued at $9 billion based on its immense promise to make blood testing cheaper and more efficient, has been embroiled in questions about its technology and regulatory strategy for months. The scrutiny was sparked by a Wall Street Journal investigation that revealed that the intensely secret company’s much-touted fingerprick blood tests were barely being used and employees had raised questions about the accuracy of its tests. (Johnson, 1/27)
CNN Money: Theranos Lab Poses ‘Immediate Jeopardy’ Biotech startup Theranos has 10 days to correct critical deficiencies with its lab. That’s according to a letter issued to the company Monday by the Centers for Medicare & Medicaid Services. (O’Brien, 1/27)
Reuters: Theranos Lab Poses ‘Jeopardy To Patient Health': Regulator Deficient practices at a lab operated by blood-testing startup Theranos pose “immediate jeopardy to patient health and safety,” the U.S. government’s Centers for Medicare & Medicaid Services said in a letter to the company released on Wednesday. Theranos, founded and led by Elizabeth Holmes, has been in the spotlight after reports in the Wall Street Journal suggested that the company’s blood-testing devices were flawed and had problems with accuracy. (1/27)
This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations.