Hologic has partnered with the US Centers for Disease Control and Prevention (CDC) to develop analyte-specific reagents (ASRs) for H5N1 detection.
ASRs are the active components of laboratory-developed tests that detect specific diseases or conditions. These reagents will support in the detection of H5N1 bird flu, also known as avian influenza A (H5N1).
US-based Hologic is collaborating with the CDC as the virus spreads among wild birds, poultry, and dairy cows in the US. Several recent cases have been found in humans.
The contract funds the proof-of-concept development of ASRs (including primers and probes) for potential use in laboratory-developed tests (LDTs) for H5N1 detection.
While not intended for commercial use currently, the medical technology firm may explore future commercialisation options if there is a need for rapid implementation of H5N1 testing.
The ASRs are being developed on the Panther Fusion system, a fully automated molecular testing platform. Panther Fusion enables labs to consolidate and run multiple assays for women’s health, infectious diseases, and SARS-CoV-2 testing.
The high-throughput Panther system has been installed in public health laboratories, hospitals, and private reference laboratories in the US. The units include several Panther Fusion systems, which can generate 1,000+ results daily and quickly scale up testing during outbreaks or pandemics.
Hologic’s Open Access functionality on the Panther Fusion system enables labs to automate and develop their LDTs.
This capability is integrated with US Food and Drug Administration (FDA)-approved in vitro diagnostic (IVD) assay workflows on the system, saving time and labour compared to manual molecular testing workflows.
Hologic diagnostic solutions president Jennifer Schneiders said: “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.
“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 development of ASRs for H5N1 bird flu detection builds on Hologic’s diagnostic portfolio, including Covid-19 assays.
In 2020, Hologic developed the Panther Fusion and Aptima SARS-CoV-2 assays, shipping over 68 million tests to 40 countries.
The women’s health-focused medical technology firm continues to innovate, recently receiving FDA clearance for a test that detects SARS-CoV-2, influenza A and B, and respiratory syncytial virus (RSV) from a single sample.
In October, the US CDC awarded several contracts to Quest Diagnostics for H5 avian influenza and Oropouche virus test development.
