FDA grants emergency use authorisation for Hologic's Aptima Zika virus assay

Hologic has announced that the US Food and Drug Administration (FDA) granted emergency use authorisation for the company'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.

The Aptima Zika virus assay has not been FDA cleared or approved and is only authorised for use for the duration of the declaration that circumstances exist, justifying the authorisation of the emergency use of in vitro diagnostic tests for detection of Zika virus and/or diagnosis of Zika virus infection.

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, minimising the labour required and the potential for manual errors. The Aptima Zika Virus assay will be available for use in all 50 states, Puerto Rico and US 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, MD, 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.’

‘Our new Aptima Zika virus assay is another reflection of our commitment to developing cutting-edge diagnostics that provide solutions for urgent unmet needs,’ said Tom West, Division President, Diagnostic Solutions at Hologic. ‘Running the Aptima Zika virus assay on the Panther system will offer quick results to epidemiologists and laboratories, which is likely to help both healthcare providers and their patients.’

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