Theranos Retracts Submission of Zika Blood Test to FDAby
Testing firm didn’t use patient-safety protocol, Journal says
Controversial lab startup appealing proposed FDA sanctions
Theranos Inc. withdrew its submission for emergency clearance of a diagnostic blood test for the Zika virus after regulators found problems with how the blood-testing startup gathered patient data.
The controversial Silicon Valley firm, which has been sanctioned by U.S. health regulators for failures to run its laboratories up to standard, said Aug. 1 that it had developed a test for the Zika virus and had submitted it to the U.S. Food and Drug Administration.
Theranos was inspected by the FDA earlier this month and regulators found that it had collected some data without implementing a patient-safety protocol approved by an institutional review board, a committee that ensures that research is done ethically and safely, the Wall Street Journal reported Tuesday.
A spokeswoman for Theranos confirmed it withdrew the application for an emergency clearance, but declined to comment on whether it had proper patient safeguards. Theranos plans to resubmit the test, he said.
Once lauded as a potentially revolutionary company in the lab industry, Theranos has been plagued by questions about the accuracy and viability of its technology. U.S. inspectors said they found failures so severe as to jeopardize patients’ health at Theranos’s lab in Newark, California, leading to proposed sanctions that would ban Chief Executive Officer Elizabeth Holmes from running a laboratory company for two years, along with monetary penalties and cancellation of payments from federal health insurance programs. Theranos is appealing the sanctions.
While a Zika test wouldn’t help to spare the company from the sanctions, clearance by the FDA would have helped Theranos regain some credibility in the eyes of skeptical consumers and physicians.