The United States Food and Drug Administration (FDA) is currently investigating the complaints filed by two former Theranos employees. Theranos spokeswoman Brooke Buchanan said the company was not provided with copies of the said complaints, which focused on research and laboratory practices.
One of the complaints was filed in September to the Centers for Medicare and Medicaid Services (CMS) stating that Theranos employees were allegedly instructed by management to carry on with the tests done on patients using controversial blood-analysis devices,which were reported as having "major stability, precision and accuracy" issues. The other complaint was filed to the FDA earlier in December, claiming that the herpes study conducted by Theranos in 2014 breached research protocols.
"Agencies have a process for evaluating complaints, and many complaints are not substantiated. We trust our regulators to properly investigate any complaints, and we look forward to continuing our strong and productive relationships with them," said Buchanan.
The hot Silicon Valley startup made headlines when the company claimed they have developed a disruptive innovation that will revolutionize the traditional blood-testing method. Its products include the Nanotainer device, which contains the finger-pricked blood sample, and the Edison machine, which can produce blood test results fast using a capsule-size blood sample.
Theranos founder and CEO Elizabeth Holmes gained media mileage and investors for the company's hotly-marketed healthcare innovation. However, the immensely private Theranos faced scrutiny when reports from The Wall Street Journal (WSJ) explored its products' accuracy and novelty. In November, auditors from CMS investigated Theranos' laboratory in Newark, California.
Both the CMS and the FDA have not issued any statement regarding the allegedly submitted claims against Theranos. The complaints are part of the ongoing public battle both Theranos and Holmes are fighting. FDA inspected two of Theranos' facilities in August and September. The results drew more blood.
The FDA reports, which were uploaded online, highlighted the misclassification of Theranos' Nanotainer device and interstate shipment of uncleared medical device. The FDA investigation also highlighted the company's failure to keep sufficient documentation and conduct quality audits as well as its poor handling of consumer complaints.
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