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Quest Diagnostics' Zika Assay Gets FDA Emergency Use Authorization

NEW YORK (GenomeWeb) – Quest Diagnostics said late on Thursday that it has received US Food and Drug Administration Emergency Use Authorization for the Zika Virus RNA Qualitative Real-Time RT-PCR test.

The assay, developed by the reference laboratory business of Quest's Focus Diagnostics subsidiary, is intended for the qualitative detection of Zika virus RNA in human serum specimens from certain individuals.

Specifically, patients must meet US Centers for Disease Control and Prevention Zika virus clinical criteria, such as exhibiting clinical signs and symptoms associated with infection; and/or CDC Zika virus epidemiological criteria, such as a history of residence in or travel to a geographic region with active Zika transmission at the time of travel.

The test is also the first from a commercial laboratory provider to be granted an EUA. In March, the FDA granted an EUA to the Trioplex Real-Time RT-PCR Assay, which was developed by the US Centers for Disease Control and Prevention and tests patient samples for Zika, chikungunya, and dengue virus infection. In February, the FDA granted an EUA to a Zika immunoassay also developed by the CDC.

Quest said that it plans to make the new test broadly available to physicians for patient testing in the US and Puerto Rico beginning 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," Rick Pesano, vice president of R&D for Quest Diagnostics, said 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," Pesano added. "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 new assay can potentially be performed at any CLIA high-complexity laboratory in the Quest Diagnostics network, which includes several dozen labs in the US and Puerto Rico. For now, only the company's Focus Diagnostics reference laboratory in San Juan Capistrano, California, will perform the test.

Quest's Focus Diagnostics subsidiary includes reference laboratory and product manufacturing businesses. Italian diagnostics firm DiaSorin is expected to complete a $300 million acquisition of the product manufacturing business in the second quarter. Quest continues to wholly own the Focus reference lab business that developed the Zika PCR test as well as intellectual property related to the test, Quest said.