FDA inspection leads to Theranos withdrawing emergency clearance of Zika Blood test: WSJ
Blood-testing firm Theranos Inc withdrew its request for emergency clearance of a Zika-virus blood test after U.S. regulators found the company did not include proper patient safeguards in a study on the test, The Wall Street Journal reported, citing people familiar with the matter.
Theranos was not immediately available for comment.
The diagnostic test for Zika can detect additional strains of the mosquito-borne virus from blood drops finger-pricked from patients, Theranos CEO Elizabeth Holmes said earlier this month.
The company said that it collected finger-stick blood samples from patients, including in the Dominican Republic, and ran the tests.
However, during an inspection by the Food and Drug Administration (FDA) 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, said the Journal.
“We hope that our decision to withdraw the Zika submission voluntarily is further evidence of our commitment to engage positively with the agency,” Theranos’s vice president of regulatory, quality and clinical affairs Dave Wurtz told the Wall Street Journal.
In an email to Theranos investors on Saturday, the company said it plans to collect additional data requested by the FDA under properly reviewed protocols and resubmit the Zika application, the Journal reported.
Theranos, who filed the request for emergency clearance to the FDA in the United States, did not contest the agency’s findings and withdrew it, the Journal said, citing the sources.
The FDA’s inspection in August was triggered by Theranos’ request for “emergency-use authorization” to sell its new Zika test, a person familiar with the matter said, the Journal reported.