Another report showed that Theranos was doing most of its testing on devices made by other companies.
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U.S. health regulators are carrying out investigation into the complaints filed against laboratory and research practices at Theranos Inc.
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Reuters could not independently reach the FDA, Centers for Medicare and Medicaid Services and Theranos for comment outside regular USA business hours.
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Theranos gained prominence and drew skepticism earlier this year with claims that it could perform a multitude of medical tests with just a few drops of blood. The herpes test, which later received FDA approval, was also modified part-way through the experiments, the former employee alleged. This month saw another ex-employee of Theranos filing a fresh complaint with the US Food & Drug Administration for the company’s herpes test. According to this new complaint, Theranos’ herpes test is tainted by violation of research protocol. It alleged that the company instructed employees to continue blood testing patients using Theranos’s devices even though there was evidence of “major stability, precision and accuracy” issues. A spokeswoman for Theranos, Brooke Buchanan, said the company has not been given any copy of the complaints, so they have no basis to evaluate whatever is mentioned in it. Case in point is the newspaper’s latest story about two former employees who filed complaints against Theranos, the company said in its note.
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Theranos claims its herpes test is evidence that its proprietary technology is both useful and reliable. Headed by founder and chief executive Elizabeth Holmes, a Stanford dropout whose fear of needles makes up the backstory/mythology behind the company’s pin-prick blood sample method, the $9 billion-valued company has now fallen under more formal scrutiny. The company rejects allegations of the veracity of the Edison devices, the company’s in-house blood testing machines and a key component of the company’s services to doctors and their patients.
