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[HEALTH] · United States · 3 sources

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Roche launches VENTANA BAP1 assay globally for mesothelioma diagnosis

Roche has announced the worldwide launch of the VENTANA BAP1 (SP527) assay, an automated immunohistochemistry test designed to assist pathologists in identifying malignant mesothelioma. The assay helps differentiate mesothelioma from other malignancies and benign tissue growth.

The test is registered as a Class I IVD with the U.S. Food and Drug Administration and has received IVDR approval as a Class C device. When used in conjunction with Roche’s MTAP and Claudin-4 assays, the BAP1 test supports more precise differential diagnosis while conserving limited patient tissue for molecular sequencing and other downstream testing.

Entities

Roche · U.S. Food and Drug Administration · VENTANA BAP1