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Quest Diagnostics secures FDA EUA status for Zika RT-PCR test

MDBR Staff Writer Published 29 April 2016

Quest Diagnostics has secured an emergency use authorization (EUA) from the US Food and Drug Administration (FDA) for its Zika virus RNA qualitative real-time RT-PCR test (Zika RT-PCR test).

Developed by the reference laboratory business of Quest's Focus Diagnostics subsidiary, the molecular test is specified for the qualitative detection of RNA from the Zika virus in human serum specimens from certain individuals.

According to Quest Diagnostics, the only Zika tests until now authorized by the FDA under EUA were available from the CDC and were only used in qualified laboratories designated by the CDC.

The new Zika RT-PCR test will be soon available to physicians for patient testing, including in Puerto Rico.

Quest Diagnostics research and development vice president Rick Pesano said: "The availability of our new molecular Zika test provides physicians broad access to a diagnostic tool for managing the Zika outbreak.

"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."

Quest Diagnostics is also planning to provide serological test services assuming FDA authorization of serological test kits for emergency use.