Hologic announced that the U.S. Food and Drug Administration (FDA) granted 510(k) clearance for its Panther Fusion® Gastrointestinal (GI) Bacterial and Expanded Bacterial Assays. Concurrently, the assays also obtained CE marking in the European Union under In Vitro Diagnostic Regulation (IVDR).
These highly sensitive molecular tests are designed for the rapid detection of common bacterial pathogens causing infectious gastroenteritis. The approvals expand Hologic's molecular diagnostics capabilities and enhance the menu available on its Panther Fusion platform.
The clearances allow Hologic to address a new diagnostic area, providing laboratories with automated, high-throughput solutions for gastrointestinal infections. This strengthens the company's position in the infectious disease testing market globally.
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