Hologic Enters into Agreement with CDC for H5N1 Bird Flu Test Development

S. Recently, several human cases of the virus have been reported among individuals who work with these animals. While the virus has caused mild illness in the U.S., severe cases have been reported in other countries. To prepare for a possible escalation of the current outbreak, Hologic (Marlborough, MA, USA) has entered into an agreement with the Centers for Disease Control and Prevention (CDC, Atlanta, GA, USA) to develop reagents for H5N1 testing.

Hologic will collaborate with the CDC to create analyte-specific reagents (ASRs), which are the essential components in laboratory-developed tests that help identify specific diseases. These reagents will be aimed at detecting H5N1 bird flu. The contract will fund the proof-of-concept phase for the development of these ASRs, including primers and probes, which could be integrated into laboratory-developed tests (LDTs) for detecting the virus. Although Hologic does not plan to commercially release these ASRs at present, the company may consider this option if rapid H5N1 testing becomes necessary. The reagents are being developed for use with the Panther Fusion system, an advanced, fully automated molecular testing platform that facilitates fast and efficient testing for various infectious diseases, including SARS-CoV-2 (COVID-19).

The Panther Fusion system, which is widely used in public health laboratories, hospitals, and private labs across the U.S., has more than 1,700 units installed. Nearly 500 of these units are Panther Fusion systems capable of processing over 1,000 results daily, and they can rapidly increase testing capacity without needing additional equipment or operator training, which is particularly useful during outbreaks or pandemics. The system’s Open Access feature also allows labs to design and automate their own LDTs, seamlessly integrating them with FDA-approved in vitro diagnostic (IVD) assays, thereby reducing time and labor when compared to traditional manual testing.

The development of ASRs for H5N1 detection builds on Hologic’s established portfolio of diagnostic tools, including those used for COVID-19. In 2020, the company swiftly developed the Panther Fusion SARS-CoV-2 assay and the Aptima SARS-CoV-2 assay, which played a pivotal role in the global pandemic response, with over 68 million tests shipped to 40 countries that year. Hologic continues to innovate, including receiving FDA clearance in 2023 for a test capable of detecting SARS-CoV-2, influenza A and B, and RSV in a single patient sample.

“During the COVID-19 pandemic, our teams pivoted rapidly and rose to the challenge of developing critical tests to help curtail the virus’s spread,” said Jennifer Schneiders, Ph.D., President, Diagnostic Solutions. “Hologic’s proven expertise in assay development, innovative instrumentation and extensive reach uniquely position us well to proactively address ever evolving and emerging public health threats.”

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