Monday, December 21, 2015
The U.S. Food and Drug Administration is investigating complaints filed by two former employees of privately held laboratory operator Theranos Inc, the Wall Street Journal reported, citing people familiar with the matter.
In September, a complaint filed by a former Theranos employee to the Centers for Medicare and Medicaid Services stated that the management instructed lab employees to continue testing patients with the company's devices, despite facing accusations that its devices were flawed and had problems with accuracy, the Journal reported.
The FDA received a second complaint earlier this month, which claimed that a study for a herpes test submitted for approval with the FDA violated research protocol, the newspaper said, upon reviewing both the complaints.
CMS auditors had examined the company's Newark lab, in November, which was part of the regular audit that the company was said to continue, the Journal said.
Theranos Chief Executive Elizabeth Holmes defended her company earlier this year, when the Wall Street Journal published stories suggesting her startup was relying on tools from traditional labs as it struggled with its own technology.
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.
According to the Journal, Theranos spokeswoman Brooke Buchanan said, the company hasn't been provided with "a copy of any alleged complaint, so we have no basis to evaluate what is in it or even if a complaint has been filed."
"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," she added in the report.
CMS and FDA spokeswomen have declined to comment to the Journal.
Reuters could not independently reach the FDA, Centers for Medicare and Medicaid Services and Theranos for comment outside regular U.S. business hours.
reuters.com
