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Roche strengthens cancer diagnostic portfolio with launch of test for differential diagnosis of mesothelioma

RHHBY
  • Roche globally launched the VENTANA BAP1 (SP527) automated immunohistochemistry test on 28 October 2026 to distinguish malignant mesothelioma from lung, breast, stomach cancers, & benign tissue growth.
  • The BAP1 assay is registered as a Class I IVD with the U.S. FDA & received IVDR approval as a Class C device.
  • IHC loss of nuclear BAP1 is virtually 100% specific for malignancy in mesothelial proliferations, aiding clinicians in confirming mesothelioma diagnoses.
  • The test helps preserve limited patient tissue samples by reducing the need for extensive antibody panels, ensuring sufficient material remains for molecular sequencing.
  • BAP1 (SP527) functions alongside Roche's MTAP (SP530) & Claudin-4 (EP417) assays to differentiate mesothelioma from non-small cell lung cancer (NSCLC) & other mimics.
  • Most mesothelioma patients are diagnosed late, resulting in a median overall survival of 12 to 18 months.
  • More than 80 percent of mesothelioma cases occur in the pleural cavity, the space between the tissue layers surrounding the lungs.
  • Lung cancer remains the leading cause of cancer death globally, with over 2.5 million new diagnoses annually & up to 85 percent of cases being NSCLC.
  • Roche's comprehensive lung cancer diagnostic portfolio includes advanced tissue diagnostics, core lab immunoassays, molecular testing, & navify digital software.
  • The assay targets the BAP1 tumor suppressor marker on chromosome 3p21 using a Rabbit Monoclonal Primary Antibody designed for automated IHC testing.