FDA has granted emergency use authorization (EUA) for a new diagnostic assay for Zika virus infection from Hologic Inc, Marlborough, Mass. 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 Panther system from Hologic automates all aspects of nucleic acid amplification testing.
The assay runs on the Hologic Panther system, an integrated platform that fully automates all aspects of nucleic acid amplification testing. The 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 US 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,” says Edward Evantash, MD, medical director and vice president of 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 for individuals meeting the Centers for Disease Control and Prevention (CDC) Zika virus clinical criteria or CDC Zika virus epidemiological criteria, by laboratories in the United States that are certified under the Clinical Laboratory Improvement Amendments of 1988 to perform high-complexity tests, or by similarly qualified non-US laboratories.
Tom West, Hologic.
“Our new Aptima Zika virus assay is another reflection of our commitment to developing cutting-edge diagnostics that provide solutions for urgent unmet needs,” says Tom West, president of the diagnostic solutions division 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.”
The Aptima Zika virus assay has not been FDA cleared or approved. It is authorized for use only for the duration of the declaration that circumstances exist justifying EUA status for in vitro diagnostic tests for detection of Zika virus and diagnosis of Zika virus infection.
For more information, visit AACC booth 1649 or Hologic.
