Roche launches VENTANA BAP1 (SP527) test for mesothelioma diagnosis
- Roche has globally launched the VENTANA BAP1 (SP527) automated IHC test.
- The assay is registered as a Class I IVD with the FDA and approved under IVDR as a Class C device.
- IHC loss of nuclear BAP1 is reported as virtually 100% specific for malignancy in mesothelial proliferations.
- Use of single high-specificity markers like BAP1 aims to minimise tissue loss and preserve samples for molecular sequencing.
Product launch and regulatory status
Roche has globally launched the VENTANA BAP1 (SP527) Rabbit Monoclonal Primary Antibody as an automated, ready-to-use immunohistochemistry (IHC) assay. The test is registered as a Class I IVD with the U.S. Food and Drug Administration and has IVDR approval as a Class C device, and is available worldwide.
Diagnostic role and performance
The assay detects nuclear loss of BAP1 expression, a tumour suppressor marker; IHC loss of nuclear BAP1 is described as virtually 100% specific for malignancy in mesothelial proliferations. The test helps distinguish malignant mesothelioma from other malignancies such as non-small cell lung cancer and from benign mesothelial proliferations. Most mesothelioma cases (>80%) are pleural, and median overall survival after diagnosis is reported at 12–18 months.
Portfolio context and tissue stewardship
BAP1 (SP527) is presented alongside other single-marker assays (VENTANA MTAP and Claudin-4) intended to reduce the need for extensive antibody panels, preserve limited tissue blocks, and ensure sufficient sample remains for essential downstream molecular sequencing and precision-medicine testing. The launch is positioned within Roche’s broader lung cancer diagnostic offerings spanning tissue diagnostics, core-lab immunoassays, molecular testing and digital software.
Source: Roche