Massachusetts-based medical technology developer Hologic has received emergency use authorization fromÂ theÂ Food and Drug Administration for a device the company developed to help clinicians detect Zika virus infections.
Hologic said FridayÂ its AptimaÂ molecular diagnostic assayÂ is designed forÂ qualitative detection of ribonucleic acid from the mosquito-borne virus in human blood samples.
TheÂ assay is basedÂ on the company’sÂ Panther system thatÂ works to automateÂ nucleic acidÂ amplification tests and seeksÂ to minimize manual errors, Hologic noted.
The diagnostic tool is approved for emergency useÂ atÂ public and private clinical laboratories in the continental U.S. and U.S. territories, Hologic noted.
Aptima is intended forÂ individuals that meet Zika virus clinical and epidemiological criteria established by the Centers for Disease Control and Prevention.