The U.S. Food and Drug Administration (FDA) has granted to Hologic emergency use authorization for the company's new, diagnostic assay for Zika virus infection. The announcement came shortly after several news outlets confirmed that three babies were born in the United States with birth defects caused by the virus. CBS News reported that "birth defects from Zika were also seen in three other pregnancies that did not reach full term."
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 assay runs on the Hologic Panther system, an 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 emergency 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. It has not yet been cleared or approved by the FDA.
"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, MD, 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 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.
To date, 234 pregnant women, including both U.S. residents and visitors, have been diagnosed with Zika.