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Home » Business, Policy & Funding » Regulatory News & FDA Approvals » Hologic Zika Tests Receive EUA, IND From FDA

Hologic Zika Tests Receive EUA, IND From FDA

Jun 20, 2016

NEW YORK (GenomeWeb) – Hologic has received regulatory authorizations from the US Food and Drug Administration for two assays aimed at detecting the Zika virus.

The firm has been granted Emergency Use Authorization (EUA) for its Aptima Zika Virus assay, a transcription-mediated amplification-based test on the integrated, fully automated Hologic Panther system. The test can now be used in qualified labs on serum and plasma samples from patients meeting US Centers for Disease Control and Prevention clinical criteria.

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