Therapy Areas: Infectious Diseases
Hologic Launches Two New Respiratory Assays for the Detection of COVID-19, Flu A, Flu B and RSV
11 July 2022 - - US-based medical technology company Hologic, Inc. (NASDAQ: HOLX) is now offering its Panther Fusion SARS-CoV-2/Flu A/B/RSV assay and its Novodiag RESP-4 molecular diagnostic test for sale in the European Union in time for the northern hemisphere's respiratory viral season, the company said.

Both assays detect and differentiate four of the most prevalent respiratory viruses that can present with similar clinical symptoms: severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza A (Flu A), influenza B (Flu B) and respiratory syncytial virus.

The Panther Fusion SARS-CoV-2/Flu A/B/RSV assay is a high-performance cartridge-based assay that runs on the fully automated high-throughput Panther Fusion system. The test uses nasopharyngeal swab samples.

The Novodiag RESP-4 assay runs on the Novodiag system, the fully automated molecular diagnostic solution that delivers on-demand testing for infectious disease and antimicrobial resistance.

This test also uses nasopharyngeal swab samples and includes an embedded cellularity control to ensure that the sample was correctly taken.

Both products are compliant with the European In Vitro Diagnostic Medical Device Directive 98/79/EC, and transition provisions for such devices included in the IVD Regulation 2017/746.

The launch of the Panther Fusion SARS-CoV-2/Flu A/B/RSV assay adds to the respiratory portfolio for the Panther Fusion system, which currently includes the Panther Fusion Flu A/B/RSV assay, the Panther Fusion Paraflu (Parainfluenza 1/2/3/4) assay, the Panther Fusion AdV/hMPV/RV (adenovirus/human metapneumovirus/rhinovirus) and the Panther Fusion Bordetella assay.

The launch of the Novodiag RESP-4 assay further expands the Novodiag assay menu, which currently includes diagnostic assays for gastrointestinal infections, hospital acquired infections, antimicrobial resistance and respiratory infections.

The Panther molecular diagnostics system is a best-in-class, fully automated, sample-to-result platform that can be used in low-, medium- or high-throughput laboratories.

With a small footprint, adaptable workflow options and consolidated testing menu, it combines women's health, sexually transmitted infection and viral load testing, which can all be done simultaneously.

The Panther Fusion system provides an expanded in vitro diagnostics menu, as well as Open Access functionality to run laboratory developed tests.

The Novodiag system combines real-time PCR and microarray capabilities that enable multiple pathogens to be identified in a single sample, providing a simple and fast way to pinpoint patients most at risk with targeted and syndromic on-demand testing.

It delivers clinically relevant results in central labs or tertiary settings and its rapid 'sample-in, result-out' system allows for the fully automated detection of novel coronavirus in approximately one hour.

It can be used as the main molecular platform for emergency, decentralised, and out-of-hours testing, or in association with the Panther System.

Hologic, Inc. is an innovative medical technology company primarily focused on improving women's health and well-being through early detection and treatment.
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