Quest Receives Emergency FDA Clearance for Zika Test

By Ron Shinkman, Editor, Laboratory Industry Report

Quest Diagnostics has received emergency clearance from the U.S. Food and Drug Administration to distribute its molecular assay for detecting the Zika virus.

The emergency clearance from the FDA is the first for a test developed by a commercial venture in the U.S. The only other rapid detection assay that was previously approved for use was developed by the U.S. Centers for Disease Control and Prevention.

The test can detect RNA from the Zika virus using specimens from patients. It was developed by the Quest subsidiary Focus Diagnostics.

The Zika outbreak, originally confined to South America, has been spreading. The CDC has noted that the virus has been transmitted by mosquito in Puerto Rico, the U.S. Virgin Islands and American Samoa. Cases have also been reported in the continental U.S., although most have been related to patients being infected overseas. The virus can cause severe birth defects in children if a pregant woman is infected with Zika.

“The availability of our new molecular Zika test provides physicians broad access to a diagnostic tool for managing the Zika outbreak,” said Rick L. Pesano, M.D., Quest’s vice president of research and development, in a statement.  “Quest’s expertise in molecular, infectious disease, and women’s health diagnostics, and relationships with half of the country’s physicians and hospitals, allow us to quickly make useful tests widely available for clinical use. This capability uniquely positions Quest to complement the response of public health laboratories for Zika outbreaks where access to FDA authorized diagnostic tests can potentially influence the quality of patient management.”

Quest did not publish a price for the test, or immediately disclose how it would be distributed.