Whistleblowers’ complaints make FDA investigate Theranos’ lab and research

Former employees of the widely watched Silicon Valley blood-testing startup Theranos Inc. have accused the company of sketchy laboratory and research practices, according to anonymous sources who spoke with the Wall Street Journal in a report published Monday. Both complaints from former employees allege Theranos managers were aware of accuracy problems with Edison, but instructed employees to continue with implementing any corrective procedures.

Holmes fought back the claims stating the company has moved away from one of its devices only briefly as it transitions to getting approval from the FDA for all of its tests. In October, the FDA also released a series of concerns about the company after visiting Theranos’s labs.

Theranos strongly claims that all its lab work is accurate and reliable.

The Journal said it reviewed copes of two complaints. However, one of the 15 tests, carried out on the company’s proprietary machine, reportedly went unscathed.

Theranos said that it has not come across any allegations and may be former employee could be “disgruntled”. A second complaint alleges the company started its study for a herpes test with partially assembled devices and then modified the machines while the study was in progress, attempting to improve their accuracy.

A spokesperson for Theranos told the WSJ that it hadn’t yet been provided with any copies of these latest complaints, so it can’t comment on them or even know if they’ve truly been filed yet.

The Centers for Medicare and Medicaid Services (CMS) are now joining the FDA and the FBI in investigating Theranos’ business practices, following complaints filed by two former Theranos employees (one complaint was sent to the FDA). After funding round past year, which valued Theranos at $9 billion, Holmes, 31, became the country’s youngest female billionaire and the sixth richest entrepreneur under 40, according to Forbes.