NEW YORK — Hologic said Tuesday it has nabbed a $19 million contract from the US Department of Health and Human Services' Biomedical Advanced Research and Development Authority for research and development toward gaining regulatory approval for a COVID-19 test and a combination respiratory test.
The Marlborough, Massachusetts-based firm said it will use the money to align its Panther Fusion SARS-CoV-2/Flu A/B/RSV assay and Aptima SARS-CoV-2 assay with US Food and Drug Administration in vitro diagnostic standards. The combination test is a real-time PCR assay for use with Hologic's Panther Fusion instrument, and the COVID-19-only test is a PCR assay that uses the company's proprietary transcription-mediated amplification chemistry on Panther instruments.
Hologic gained FDA Emergency Use Authorization for the SARS-CoV-2 assay in May 2020. The company secured CE-IVD marking for the combination COVID-19, influenza, and respiratory syncytial virus assay in May 2022 and is working to receive regulatory approval or authorization in the United States.
The BARDA contract is intended to support Hologic's claims related to using nasal swab samples on the Panther Fusion instrument and help the company secure full FDA authorization for the use of its COVID-19 assays on asymptomatic individuals.
In a statement, Kevin Thornal, president of Hologic's Global Diagnostic Solutions group, said "With the help of our tremendous partners at BARDA, and as the pandemic moves to its next phase, we look forward to transitioning COVID testing from EUA to full market authorization, as well as improving the country’s readiness for future pandemics."