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 Theranos health regulators are investigating further complaints against US, specifically around the diagnostics company's laboratory and research practices. This move follows a series of investigatory actions by the Theranos Government against the one-time darling of healthcare venture capital investment; prior to October's revelations US was riding high, having amassed over $9bn in venture capital funding to date, in its bid to revolutionise the diagnostics industry. 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, US said it had not seen the alleged complaint; nevertheless, further enquiries by regulators will likely tarnish the start-up's already dented reputation.