FDA Grants Emergency Use Authorization for Hologic's Aptima^® Zika Virus Assay

Hologic, Inc. has announced that the U.S. Food and Drug Administration (FDA) granted emergency use authorization for the company's new, diagnostic assay for Zika virus infection.

The Aptima^® Zika Virus assay is a molecular diagnostic tool for the qualitative detection of RNA from Zika virus in human serum and plasma specimens. The Aptima Zika Virus assay has not been FDA cleared or approved and is only authorized for use for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostic tests for detection of Zika virus and/or diagnosis of Zika virus infection.

The Aptima Zika Virus assay runs on the Hologic Panther^® system, a market-leading, integrated platform that fully automates all aspects of nucleic acid amplification testing. The Panther system substantially reduces hands-on time for laboratories, minimizing the labor required and the potential for manual errors. The Aptima Zika Virus assay will be available for use in all 50 states, Puerto Rico and U.S. territories, expanding the number of public and private labs that can test for the virus.

"We want to ensure that during this critical summer season and beyond, those at risk for the Zika virus have an opportunity to be tested with a highly sensitive assay," said Edward Evantash, M.D., medical director and vice president, Medical Affairs at Hologic. "Our new test will help to ensure accurate diagnoses and reduce subsequent spread of the infection."

The Aptima Zika Virus assay is designed to be used in 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 laboratories in the United States that are certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. § 263a, to perform high complexity tests, or by similarly qualified non-U.S. laboratories.

"Our new Aptima Zika Virus assay is another reflection of our commitment to developing cutting-edge diagnostics that provide solutions for urgent unmet needs," said Tom West, division president, Diagnostic Solutions at Hologic. "Running the Aptima Zika Virus assay on the Panther system will offer quick results to epidemiologists and laboratories, which is likely to help both healthcare providers and their patients."