Hologic entered an agreement with the with the Centers for Disease Control and Prevention (CDC) to develop analyte-specific reagents (ASRs) that would aid in detection of H5N1 bird flu.

ASRs are the “active ingredients” of lab-developed tests (LDTs) used to identify specific diseases or conditions.

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. To prepare for if the current outbreak worsens, Hologic said it will work with the CDC to develop reagents that may be used for H5N1 testing.

The contract will fund proof-of-concept development of ASRs—primers and probes, in this instance—that could be incorporated into LDTs to detect H5N1. Hologic said it doesn’t currently intend to make the ASRs commercially available, but may explore future commercialization should the need for rapid implementation of testing come about.

The ASRs are being developed on Hologic’s Panther Fusion system, a fully automated molecular testing platform that lets labs to quickly consolidate and run multiple assays for women’s health, infectious disease, and SARS-CoV-2 (COVID-19) testing.

Hologic’s Open Access functionality on the Panther Fusion system also allows labs to develop and automate their own LDTs using a workflow that’s 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 to more manual, low-throughput molecular testing workflows.

“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 at Hologic. “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.”