By Diagnostics World Staff
June 20, 2016 | On Friday, the U.S. Food and Drug Administration (FDA) granted emergency use authorization for Hologic’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. In the emergency use authorization letter, FDA Commissioner Robert Califf noted that the Zika virus poses, “significant potential for a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad.” In response to that threat, FDA has issued an emergency use authorization that will be in effect until the virus is no longer a threat.
The authorization—not drug approval—is limited to, “individuals meeting 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,” Califf wrote.
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, 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.”
“Zika viral RNA is generally detectable in serum during the acute phase of infection (approximately 7 days following onset of symptoms, if present),” Califf wrote in the authorization letter. “Positive results are indicative of current infection.”
In the letter’s three listed criteria for authorization, Califf noted that, first, the Zika virus can cause a serious or life-threatening infection. Second, “Based on the totality of scientific evidence available to FDA, it is reasonable to believe that the Aptima Zika Virus assay, when used with the specified instrument and in accordance with the Scope of Authorization, may be effective in detecting Zika virus and diagnosing Zika virus infection,” he wrote.
And finally, “There is no adequate, approved, and available alternative to the emergency use of the Aptima Zika Virus assay for detecting Zika virus and diagnosing Zika virus infection.”
Screening the Blood Supply
In a separate announcement today, Hologic and Grifols, a transfusion medicine company, announced that FDA has approved the Procleix Zika virus blood screening assay on the Procleix Panther system under the agency's Investigational New Drug (IND) study protocol.
Prominent U.S. blood centers will use the Procleix Zika virus assay to screen donated blood collected in potential endemic areas of the southern U.S., and may expand testing to other areas of the U.S. if the virus continues to spread.
"The American Red Cross is pleased to participate in the Procleix Zika Virus assay investigational study, which will allow us to begin blood donor testing for Zika virus early this summer in areas most likely to have local mosquito transmission of the virus," said Susan Stramer, Vice President of Scientific Affairs at the American Red Cross, in a statement. "Working together, we remain committed to ensuring the safety and availability of the U.S. blood supply for patients in need."
The Grifols Procleix portfolio of nucleic acid technology (NAT) products are developed as part of a long-standing partnership between Hologic and Grifols. Procleix systems are used to screen more blood donations around the world than any other NAT blood screening products, and include tests for HIV, hepatitis, West Nile virus and more.
"Zika virus is a rapidly growing threat to public health," said Tom West, Division President, Diagnostic Solutions at Hologic, in a statement. "Today's announcement demonstrates our ability to quickly develop molecular diagnostics in response to new and emerging pathogens."