Ex-employee complaint puts Theranos Only FDA approved test under scrutiny

Two ex-employees of consumer healthcare technology firm Theranos have filed complaints with the Centers for Medicare & Medicaid Services (CMS) and the US Food & Drug Administration (FDA) over alleged flawed test results.

The most recent complaint has been aimed at a test conducted for herpes; the said test is the only one from the blood diagnostic startup Theranos that has been approved by the FDA so far for being run using the company’s proprietary technology.

One of the ex-employees filed the complaint in September 2015 to the CMS accusing that the company’s upper management ordered laboratory employees to keep on using the proprietary blood testing technology of Theranos in spite of knowing that there were indications of major accuracy, stability and precision with those procedures.

The FDA treated the complaint as a warning sign, and almost immediately it decided to stop the company from using one of its nanotainers (tiny vials or containers of blood) purported for delivering precise test results at various conditions. The healthy agency tagged the nanotainers as un-cleared medical devices after carrying out an inspection at the California facilities of Theranos.

This incident forced Theranos to enter a self-imposed dormancy in October. During this period, the company waited for the FDA approving its technology for being used in other tests. However, one of the 15 tests, carried out on the company’s proprietary machine, reportedly went unscathed.

The FDA gave Theranos’ test for herpes on that proprietary machine green signal in July 2015, which made it the only test from Theranos to get FDA’s nod.

However, we might see the things getting worse for the consumer healthcare technology company. 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.


So, what the current situation means for Theranos? Reports are suggesting that the company hasn’t yet seen these allegations, and it is confident that the ex employee took the step as a result of being unhappy with Theranos.

Here, it must be mentioned that this is not the first time we are seeing people complaining about Theranos’ technology. This is also not the first time someone is expressing his or her concern about the company’s testing practices.