The Food and Drug Administration has granted Quest Diagnostics, a clinical laboratory services company, an Emergency Use Authorization for Quest's Zika Virus RNA Qualitative Real-Time RT-PCR test, a proprietary molecular test to detect Zika virus in humans.
According to Quest, the Zika test is the first from a commercial laboratory to receive an EAU for testing patients' RNA for the virus. Previously, the only Zika blood tests with an EAU were from the CDC and could only be used in CDC-designated laboratories.
"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, MD, PhD, vice president of research and development of Quest Diagnostics. "Quest's expertise in molecular, infectious disease and women's health diagnostics…allow us to quickly make useful tests widely available for clinical use."
The company's expertise and relationships with physicians and hospitals around the country "uniquely positions" Quest to help public health laboratories respond to Zika outbreaks and potentially influence the quality of patient management.
Quest Diagnostics plans to make the test available to physicians for patient testing by early May.
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