Summary: Hologic, Inc. has partnered with the CDC to develop analyte specific reagents (ASRs) to detect H5N1 bird flu.
Takeaways:
- Hologic will develop ASRs for H5N1 detection on their Panther Fusion system, enhancing rapid and scalable testing capabilities.
- The ASRs will support laboratory-developed tests for H5N1, aiding in early detection and response to potential outbreaks.
- This initiative builds on Hologic’s expertise in diagnostic solutions, including their significant contributions during the COVID-19 pandemic.
Hologic, Inc. announced that it has entered into an agreement with the Centers for Disease Control and Prevention (CDC) to develop analyte specific reagents (ASRs —the “active ingredients” of laboratory-developed tests used to identify specific diseases or conditions—that would aid in the detection of H5N1 bird flu.
H5N1 Bird Flu Continues to Spread
H5N1 bird flu, also known as avian influenza A (H5N1), continues to spread among wild birds worldwide and is causing outbreaks in poultry and dairy cows in the U.S., with several recent cases identified in humans who work with these animals.1 Illness from the virus in the U.S. has been mild but severe illness in other countries has been associated with this virus.2 To prepare for if the current outbreak worsens, Hologic will work with the CDC to develop reagents that may be used for H5N1 testing.
“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,” says 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.”
The contract will fund proof-of-concept development of ASRs—primers and probes, in this case—that could eventually be incorporated into laboratory-developed tests (LDTs) designed to detect H5N1. While Hologic does not currently intend to make these ASRs commercially available, the company may explore future commercialization should the need for rapid implementation of H5N1 testing arise.
Automated Molecular Testing Platform to Fuel Development
The ASRs are being developed on the Panther Fusion system, a fully automated molecular testing platform that allows labs to quickly consolidate and run multiple assays for women’s health, infectious disease and SARS-CoV-2 (COVID-19) testing.
The high-throughput Panther system has an extensive presence throughout the laboratory community, with more than 1,700 systems installed in public health laboratories, hospitals and private reference laboratories across the U.S. Nearly 500 of the U.S. Panther systems installed are Panther Fusion systems, which can generate over 1,000 results in 24 hours and have the flexibility to rapidly scale up testing capacity without the need for additional instruments or operator training in the event of an outbreak or pandemic.
Hologic’s Open Access functionality on the Panther Fusion system also allows labs to develop and automate their own LDTs using a workflow that is easily integrated with U.S. Food and Drug Administration (FDA)-approved in vitro diagnostic (IVD) assay workflows on the system. This can help save time and labor compared with more manual, low-throughput molecular testing workflows.
H5N1 Bird Flu ASRs Build on Hologic’s Existing Portfolio
The development of these ASRs for detection of H5N1 bird flu builds on Hologic’s existing strong portfolio of diagnostic solutions, including assays used for detection of COVID-19. In 2020, Hologic rapidly developed the Panther Fusion SARS-CoV-2 assay and the Aptima SARS-CoV-2 assay. These tests played a critical role in the global pandemic response, with more than 68 million shipped to 40 countries in 2020 alone. The company continues to innovate in this area, most recently with FDA clearance in 2023 of a test that can detect SARS-CoV-2, influenza A and B, and RSV in a single patient sample.
References
1 Centers for Disease Control and Prevention. H5 Bird Flu: Current Situation. https://www.cdc.gov/bird-flu/situation-summary/index.html
2 Centers for Disease Control and Prevention. What Causes Bird Flu Virus Infections in Humans? https://www.cdc.gov/bird-flu/virus-transmission/avian-in-humans.html
SOURCE: Hologic, Inc.
