It was supposed to be the beginning of a new era when Elizabeth Holmes, the chief executive of the beleaguered blood-testing company Theranos, took the stage at a major scientific conference earlier this month and presented a new technology and data on a Zika test. The company, Holmes told thousands of scientists, had already submitted the test to federal regulators for emergency-use authorization.
But federal inspectors visited Theranos soon after and found that some of the Zika data collection had gone forward without an essential safeguard to prevent patient harm, according to a Wall Street Journal report published late Tuesday. The company confirmed that it has withdrawn its Zika test from consideration.
The setback comes as a separate agency — the Centers for Medicare and Medicaid Services — considers Theranos's appeal of harsh sanctions that included a two-year ban on Holmes owning or operating a laboratory after numerous deficiencies were found at its Newark, Calif. laboratory.
"It's unfortunate for Theranos to be caught in another compliance issue so soon after the major issues were reported with their clinical testing laboratory," Stephen Master, director of the central lab at Weill Cornell Medical College, wrote in an email. "Given the amount of scrutiny they're under, I would have expected them to be particularly careful about the regulatory issues surrounding research on human subjects."
Citing unnamed people familiar with the matter, the Wall Street Journal reported that inspectors found that some of Theranos's Zika data was collected without approval by an institutional review board, a committee that performs a critical stopgap function in medicine — overseeing and monitoring research, to make sure it doesn't pose a threat to patient safety.
"The FDA cannot confirm the existence of or comment on any current/pending product applications," agency spokeswoman Tara Goodin wrote in an email.
According to the company's earlier news release about the Zika test, finger-stick blood samples were collected from patients in the Dominican Republic and shipped to Palo Alto, Calif., where the company is headquartered. That release also specified that the data that were presented in its scientific presentation in early August were conducted under protocols that had been approved by an institutional review board.
The company plans to resubmit the test for approval.
“In my mind, this was a positive interaction with the FDA, and I’m grateful for its collaborative approach," Dave Wurtz, Theranos's vice president of regulatory, quality and clinical affairs said in a statement. "We hope that our decision to withdraw the Zika submission voluntarily is further evidence of our commitment to engage positively with the agency. We are confident in the Zika tests and will resubmit it.”
Since the announcement of the sanctions, "Theranos has made substantial progress toward correcting the deficiencies CMS identified, including appointing new laboratory leadership; enhancing Theranos’ clinical policies and procedures; and revamping training programs," the company said in a statement.
CMS spokesman Tony Salters said the appeal is under review and that as with any ongoing enforcement issue, the agency would not comment further.