(Reuters) - Blood-testing firm Theranos Inc said it voluntarily withdrew a request to the U.S. Food and Drug Administration for emergency clearance of its Zika-virus blood test.
Theranos made the decision after the FDA said the company did not include proper patient safeguards in a study, the Wall Street Journal reported, citing people familiar with the matter.
“We hope that our decision to withdraw the Zika submission voluntarily is further evidence of our commitment to engage positively with the agency,” Dave Wurtz, Theranos’ vice president of regulatory, quality and clinical affairs said in a statement.
“In my mind, this was a positive interaction with the FDA, and I’m grateful for its collaborative approach. We are confident in the Zika tests and will resubmit it.”
The diagnostic test for Zika can detect additional strains of the mosquito-borne virus from blood drops taken from a finger pricks from patients, Theranos Chief Executive Elizabeth Holmes said earlier this month.
The company said that it collected finger-stick blood samples from patients, including from those in the Dominican Republic, and ran the tests.
However, after an inspection earlier this month, the FDA concluded that Theranos had collected some data supporting the accuracy of the test without implementing a patient-safety protocol approved by an institutional review board, the Journal said. (on.wsj.com/2c33MFf)
The FDA’s inspection was triggered by Theranos’ request for “emergency-use authorization” to sell its new Zika test, the WSJ said.
Reporting by Vishaka George in Bengaluru; Editing by Andrew Hay and Savio D'Souza