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Hologic Nabs FDA 510(k) Clearance for Respiratory Assay

NEW YORK – Hologic said Friday that it secured US Food and Drug Administration 510(k) clearance for a multiplex respiratory panel for SARS-CoV-2, influenza A and B, and respiratory syncytial virus.

The CE-marked real-time RT-PCR test is designed for use on the firm's fully automated high-throughput Panther Fusion instrument, which provides initial test results in about three hours and can process more than 1,000 tests in 24 hours. The firm simultaneously launched its RespDirect collection kit that lets laboratories load samples directly into the Panther Fusion system without uncapping or specimen-transfer steps, which it said reduces the risks of error, virus exposure, and repetitive stress injuries.

The company developed the multiplex respiratory test with funding from the US Department of Health and Human Services Biomedical Advanced Research and Development Authority (BARDA). Federal government information indicates the firm received $14.8 million for that contract since January 2021. The firm also inked a $19 million contract in November from BARDA to align the Panther Fusion multiplex test and an Aptima SARS-CoV-2 assay with FDA in vitro diagnostics standards.

"While we are out of the respiratory virus season this year, accurate viral diagnosis remains a high priority for clinicians for the coming respiratory season and we are committed to advancing COVID and respiratory diagnostics on our Panther Fusion System," Hologic Diagnostic Solutions President Jennifer Schneiders said in a statement.

"This test will be a critical tool to help determine which respiratory virus or coinfection patients have so that providers can better inform the best course of treatment," Schneiders added.

Hologic said it has shipped more than 200 million SARS-CoV-2 laboratory tests worldwide. The firm said earlier this month its diagnostics revenues had fallen year over year for its fiscal second quarter on an expected decline in COVID-19 revenues, which brought in $71 million during Q2 2023.