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Hologic Zika Tests Receive EUA, IND From FDA

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.

The test is the fourth nucleic acid amplification-based Zika test granted EUA by the FDA. In addition to a CDC Trioplex PCR assay that tests for Zika, dengue, and chikungunya viruses, EUA has also been granted to Zika assays from Quest Diagnostics and Altona Diagnostics.

The FDA also approved Hologic's Procleix Zika virus blood screening assay under the Investigational New Drug (IND) study protocol. The approval was granted to Hologic and its blood safety partner Grifols.

Procleix is the blood screening system used by the American Red Cross to test donated blood for HIV, and hepatitis B and C viruses. The Red Cross will now add the Zika test under the IND study protocol in potential Zika endemic areas in the Southern US, and may expand to other areas if the virus spreads, Hologic said in a statement.

Hologic's competitor in the blood screening market, Roche, received IND for a Zika assay for blood screening in March, and the CDC presented data last week on its use in Puerto Rico.