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June 20, 2016

Hologic secures FDA emergency use authorisation for Aptima Zika Virus assay

US-based medical device company Hologic has received emergency use authorisation from the US Food and Drug Administration (FDA) for its Aptima Zika Virus assay to detect Zika virus.

Zika

US-based medical device company Hologic has received emergency use authorisation from the US Food and Drug Administration (FDA) for its Aptima Zika Virus assay to detect Zika virus.

The Aptima Zika Virus assay is a transcription-mediated amplification test designed for a qualitative detection of RNA from the Zika virus by testing human serum and plasma specimens.

It is based on the Hologic Panther system, which is an integrated platform that fully automates all the every stage of nucleic acid amplification testing.

The Panther system assists in reducing the hands-on time involved in laboratories and the labour required, subsequently decreasing the risk of manual errors.

It also has the flexibility to cater to high and low-test volumes suited to requirements of time.

It has been developed in the wake of Zika virus outbreaks, which is a mosquito-borne virus that can also be transmitted from the mother to the fetus during pregnancy.

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

The virus can also be transmitted from men to sexual partners through semen, as well as through blood during transfusion.

Hologic medical affairs medical director and vice-president 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."

The assay is applicable to individuals meeting Centers for Disease Control and Prevention (CDC) Zika virus clinical criteria and / or CDC Zika virus epidemiological criteria.


Image: Zika-virus carrying adult Aedes aegypti mosquito. Photo: courtesy of Muhammad Mahdi Karim.

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