The FDA granted Quest Diagnostics an Emergency Use Authorization (EUA) for the Zika Virus RNA Qualitative Real-Time RT-PCR test (Zika RT-PCR test). The test was developed by the reference laboratory business of Quest’s Focus Diagnostics subsidiary. The proprietary molecular test is intended for the qualitative detection of RNA from the Zika virus in human serum specimens from certain individuals.
The test is the first from a commercial laboratory provider to be granted an EUA for testing patients for Zika virus RNA. Until now, the only Zika tests authorized by the FDA under EUA were available from the CDC and were only used in qualified laboratories designated by the CDC. Quest Diagnostics plans to make the new test broadly available to physicians for patient testing, including in Puerto Rico, early in the week of May 2, 2016.
“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., Ph.D., vice president, research and development, Quest Diagnostics. “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.”
The EUA authorizes qualified laboratories designated by Focus Diagnostics and in the U.S. certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform high-complexity tests to perform the Zika RT-PCR test. This test can potentially be performed at any CLIA high-complexity laboratory in the Quest Diagnostics network, which includes several dozen CLIA high-complexity labs in the United States, including in Toa Baja, Puerto Rico. For now, only the company’s Focus Diagnostics reference laboratory in San Juan Capistrano, California, which developed and validated the new test, will perform this test.