U.S. health regulators are investigating complaints about laboratory and research practices at Theranos Inc. by two former employees of the blood-testing startup company, according to people familiar with the inquiries. A complaint filed in September by a former Theranos lab employee to the Centers for Medicare and Medicaid Services alleged that management instructed lab employees to keep testing patients with the company’s blood-analysis devices despite indications of “major stability, precision and accuracy” problems with...
Citing people familiar with the topic, the Wall Street Journal reports that US health regulators are investigating further complaints against Theranos, specifically around the diagnostics company's laboratory and research practices. The investigation is being conducted by the Food and Drug Administration (FDA), which has been looking into whether Theranos violated federal laws governing medical device manufacturers. New complaints allege that customer tests continued despite reports that the devices performing them had “major stability, precision and accuracy” issues. While both the CMS and FDA declined to comment, Theranos said it had not seen the alleged complaint; nevertheless, further enquiries by regulators will likely tarnish the start-up's already dented reputation.