Hologic has agreed with the US Centers for Disease Control and Prevention (CDC) to create analyte-specific reagents (ASRs) that could assist in identifying the H5N1 bird flu also referred to as avian influenza A (H5N1).
These reagents considered the ‘active ingredients’ of laboratory-developed tests (LDTs), are crucial for detecting certain conditions. The development is in response to the continued spread of H5N1 among wild birds and domestic animals in the US, with human cases recently reported.
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This initiative is set to develop proof-of-concept probes and primers that could be integrated into LDTs designed for H5N1 identification. It builds upon Hologic’s portfolio of diagnostic solutions, including Covid-19 assays.
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.”
Although there are no immediate plans to commercialise these ASRs, Hologic may consider future commercialisation if rapid H5N1 testing becomes necessary.
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By GlobalDataThe ASRs are being designed for use with a molecular testing platform, Panther Fusion system, which can perform a wide range of assays, including those for infectious diseases, Covid-19, and women’s health.
Known for its ‘high-throughput’ capabilities, Panther Fusion is used across the US in various laboratories and it can deliver more than 1,000 outcomes within 24 hours.
Its ‘Open Access’ functionality further enables laboratories to develop and automate their LDTs, streamlining the integration with Food and Drug Administration (FDA)-approved test workflows.
In 2020, the company developed the Aptima SARS-CoV-2 and Panther Fusion SARS-CoV-2 assays that were pivotal in the pandemic response, with more than 68 million units distributed across 40 countries.
The company gained clearance from the US regulator last year for a test that can identify multiple respiratory viruses from a single patient sample.
In July, Hologic completed the acquisition of Endomagnetics, a UK-based developer of breast cancer surgery technologies, for nearly $310m.
