Theranos Inc. withdrew its request for emergency clearance of a Zika-virus blood test after federal regulators found that the company didn’t include proper patient safeguards in a study of the new test, said people familiar with the matter.
The move is another setback for the Palo Alto, Calif., company as it tries to recover from crippling regulatory sanctions that followed revelations by The Wall Street Journal of shortcomings in Theranos’s technology and operations. Theranos has said it is appealing.
Theranos founder Elizabeth Holmes announced Aug. 1 a new blood-testing device called miniLab that she said was designed for use outside a clinical laboratory and could run accurate tests from a few drops of blood.
Ms. Holmes also said Theranos was seeking clearance for its Zika test, and a company news release said Theranos had collected finger-stick blood samples from patients, including in the Dominican Republic, and run the tests on the new miniLab device, which showed that the Zika test worked.
But during an inspection by the Food and Drug Administration earlier this month, regulators concluded that Theranos had collected some data supporting the accuracy of the Zika test without implementing a patient-safety protocol approved by an institutional review board, according to the people familiar with the matter. Institutional review boards ensure that patients are treated safely and ethically during medical studies.
“We hope that our decision to withdraw the Zika submission voluntarily is further evidence of our commitment to engage positively with the agency,” said Dave Wurtz, Theranos’s vice president of regulatory, quality and clinical affairs. An FDA spokeswoman declined to comment on the inspection, citing the agency’s policy on pending product applications.