Log in or Register for enhanced features | Forgotten Password?
White Papers | Suppliers | Events | Report Store | Companies | Dining Club | Videos
Diagnostics
In Vitro Diagnostics
Return to: MDBR Home | Diagnostics | In Vitro Diagnostics

FDA grants EUA status for Hologic’s Aptima Zika Virus assay

MDBR Staff Writer Published 20 June 2016

Hologic has secured emergency use authorization (EUA) status from the US Food and Drug Administration (FDA) for its new Aptima Zika Virus assay.

Zika virus is an emerging mosquito-borne virus that was first identified in rhesus monkeys in Uganda in 1947 and in humans in 1952, according to the World Health Organization.

The company has developed the new molecular diagnostic tool for the qualitative detection of RNA from Zika virus in human serum and plasma specimens.

Aptima assay works on the firm's Panther system, which automates all aspects of nucleic acid amplification testing.

It can be used in individuals meeting Centers for Disease Control and Prevention (CDC) Zika virus clinical criteria and CDC Zika virus epidemiological criteria.

The assay is provided in all 50 states, Puerto Rico and the US territories.

Hologic medical affairs vice president and medical director Dr Edward Evantash said: "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.

"Our new test will help to ensure accurate diagnoses and reduce subsequent spread of the infection."

Hologic diagnostic solutions division president Tom West said: "Our new Aptima Zika Virus assay is another reflection of our commitment to developing cutting-edge diagnostics that provide solutions for urgent unmet needs."