On April 28, 2016, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) to authorize the emergency use of Focus Diagnostics, Inc.’s, Zika Virus RNA Qualitative Real-Time RT-PCR test for the qualitative detection of RNA from Zika virus in human serum specimens from individuals meeting Centers for Disease Control and Prevention (CDC) Zika virus clinical criteria (e.g., clinical signs and symptoms associated with Zika virus infection) and/or CDC Zika virus epidemiological criteria (e.g., history of residence in or travel to a geographic region with active Zika transmission at the time of travel, or other epidemiologic criteria for which Zika virus testing may be indicated), by qualified laboratories designated by Focus Diagnostics, Inc., and, in the United States, certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), to perform high complexity tests.
In a release from Focus Diagnostic’s parent company, Quest Diagnostics:
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.
“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.”
Zika Virus RNA Qualitative Real-Time RT-PCR test is a real-time RT-PCR test intended only for the qualitative detection of RNA from the Zika virus in human serum specimens from patients meeting Centers for Disease Control and Prevention (CDC) Zika virus clinical criteria (e.g., clinical signs and symptoms associated with Zika virus infection) and/or CDC Zika virus epidemiological criteria (e.g., history of residence in or travel to a geographic region with active Zika transmission at the time of travel, or other epidemiologic criteria for which Zika virus testing may be indicated ). Testing is limited to qualified laboratories designated by Focus Diagnostics, Inc.
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