Industry News: New Zika Virus Assay Now CE Marked in Europe

14 Feb 2017


Hologic, Inc. have announced the Company's Aptima® Zika Virus diagnostic assay is now CE marked in Europe for the detection and diagnosis of the Zika virus in patients at risk of exposure to Zika or with signs and symptoms of the virus. The Aptima® Zika Virus assay is a molecular diagnostic test that identifies the presence of Zika RNA in human serum, plasma and urine specimens, that can be used up to 14 days following the onset of symptoms.

The Aptima® Zika Virus assay is the latest Hologic test designed to run on the Company’s Panther® system, a market-leading, integrated platform that fully automates all aspects of nucleic acid amplification testing. By reducing hands-on time, the Panther® system helps to minimize labor needs and the potential for manual errors.

"At Hologic, we are driven to provide solutions to some of society's most urgent unmet health needs,” said João Malagueira, VP Sales Diagnostics, International. “The development of the Aptima® Zika Virus assay and its launch in Europe is a reflection of how we live up to this commitment. While the number of cases of the Zika virus in Europe is currently low, our new, highly sensitive assay will help ensure accurate diagnoses and reduce subsequent risk of infection.”