Hologic, Inc. (Nasdaq: HOLX) announced today that it has signed an agreement with the Centers for Disease Control and Prevention (CDC) to develop analyte specific reagents (ASRs) — key components of laboratory-developed tests — to assist in detecting H5N1 bird flu.
H5N1 bird flu, or avian influenza A (H5N1), is spreading among wild birds globally and causing outbreaks in poultry and dairy cows in the U.S. Recent cases of human infection have also been reported among individuals working with these animals, although illness in the U.S. has been mild. However, severe illness from H5N1 has been observed in other countries. In preparation for a potential escalation of the current outbreak, Hologic has partnered with the Centers for Disease Control and Prevention (CDC) to develop reagents for H5N1 testing.
Jennifer Schneiders, Ph.D., President of Diagnostic Solutions at Hologic, stated, “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.” She added that Hologic’s extensive expertise in assay development, innovative technology, and broad reach place the company in a unique position to address emerging public health threats.
This agreement will fund the proof-of-concept development of analyte specific reagents (ASRs), including primers and probes, which could be integrated into laboratory-developed tests (LDTs) to detect H5N1. While Hologic does not plan to commercialize these ASRs at this time, the company may explore commercialization should the need for rapid H5N1 testing arise.
The ASRs will be developed on Hologic’s Panther Fusion® system, a fully automated molecular testing platform capable of consolidating and running multiple assays for infectious diseases, women’s health, and COVID-19 testing. The Panther® system, known for its high throughput, has more than 1,700 systems installed in public health labs, hospitals, and private reference labs across the U.S. Nearly 500 of these systems are Panther Fusion units, which can process over 1,000 results in 24 hours. The Panther Fusion system is also adaptable, able to scale up testing capacity quickly without the need for additional instruments or extensive operator training, making it ideal for responding to outbreaks or pandemics.
Hologic’s Open Access® functionality on the Panther Fusion system also allows labs to develop and automate their own LDTs, which can be integrated with U.S. Food and Drug Administration (FDA)-approved in vitro diagnostic (IVD) assays. This feature helps save time and labor, improving efficiency over traditional, more manual testing workflows.
The development of ASRs for H5N1 testing builds on Hologic’s strong portfolio of diagnostic solutions. The company played a pivotal role in the COVID-19 response, rapidly developing the Panther Fusion® SARS-CoV-2 assay and the Aptima® SARS-CoV-2 assay in 2020. These tests were critical in managing the pandemic, with more than 68 million tests shipped to 40 countries that year. Hologic continues to innovate, most recently gaining FDA clearance in 2023 for a test that detects SARS-CoV-2, influenza A and B, and RSV in a single sample.
About Hologic, Inc. Hologic, Inc. is a global leader in women’s health, dedicated to developing innovative medical technologies that detect, diagnose, and treat health conditions, ultimately raising the standard of care worldwide.
