First Commercial Lab Gets FDA Emergency Clearance for Zika Test

The Zika virus continues to receive attention from federal agencies as Quest Diagnostics recently 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 pregnant woman is infected with Zika. As of May 11, 2016 there were no locally transmitted (mosquito borne) cases of the infection reported in the continental U.S. However, the Centers for Disease Control and Prevention (CDC) reported that as of that date there were 503 travel associated cases for the continental U.S. and 698 locally acquired cases reported for the U.S. territories. U.S. Health and Human Services (HHS) Secretary Sylvia Burwell recently visited Puerto Rico to meet with local authorities and CDC and HHS staff working in Puerto Rico to assist with infection surveillance and managing demand for laboratory testing and research.

“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.”

Use of the test is limited to qualified laboratories Focus designates and the emergency clearance does not mean the test has FDA clearance or approval. Rather the FDA has cleared it for use during the public health emergency, which was declared in February 2016. It is authorized for use in detecting RNA from Zika virus and diagnosing the Zika virus in patients “meeting CDC Zika virus clinical criteria (e.g., clinical signs and symptoms associated with Zika virus infection) and/or CDC Zika virus epidemiological criteria” such as a history of living in or traveling to a location dealing with a Zika outbreak. During the emergency use authorization, the FDA will waive certain requirements such as quality system requirements and labeling requirements. Focus must track adverse events and report them to the FDA and document test performance such as false positives and false negatives and satisfy numerous other conditions to the emergency authorization.

Takeaway: The battle against Zika continues with the first commercial test becoming available under an emergency use authorization.