Blood-testing firm Theranos 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.