The automated immunohistochemistry test helps pathologists identify malignant mesothelioma while preserving biopsy tissue for additional testing.
Roche announced the global launch of the VENTANA BAP1 (SP527) test, an automated, ready-to-use immunohistochemistry (IHC) assay designed to help pathologists accurately identify mesothelioma and differentiate it from other malignancies, including non-small cell lung cancer. The assay is registered as a Class I IVD with the US Food and Drug Administration, has received IVDR approval as a Class C device, and is available globally.
Malignant mesothelioma is a rare, life-threatening cancer that develops in the thin tissue lining internal organs, with more than 80% of cases presenting in the pleural cavity. Most patients receive a diagnosis late in disease progression, resulting in a median overall survival of 12 to 18 months. The assay is also designed to help clinicians distinguish mesothelioma from breast cancer, stomach cancer, and benign tissue growths located in the chest or abdomen.
“Timely differential diagnosis of mesothelioma is critical to help deliver the best outcome for patients. Adding BAP1 to our portfolio underscores our commitment to developing innovative solutions that enable healthcare systems around the world to address diseases with high unmet need, such as mesothelioma,” says Matt Sause, CEO of Roche Diagnostics, in a release.
Optimizing Tissue Preservation for Molecular Workups
A central challenge in lung cancer and mesothelioma diagnostics is preserving limited patient tissue samples. Traditional diagnostic pathways can exhaust tissue blocks through broad antibody panels. In contrast, highly specific single markers, such as the BAP1 (SP527) assay alongside the recently launched VENTANA MTAP (SP530) and VENTANA Claudin-4 (EP417) tests, enable pathologists to differentiate cancers while minimizing tissue loss.
Conserving tissue during the initial diagnostic phase ensures sufficient sample remains for downstream molecular sequencing, oncology PCR, and precision medicine testing.
Assay Specificity in Mesothelial Proliferations
The VENTANA BAP1 (SP527) rabbit monoclonal primary antibody is designed for automated IHC testing to detect the loss of nuclear BAP1 expression. BAP1 functions as a tumor suppressor marker located on chromosome 3p21.
The loss of nuclear BAP1 expression via IHC is virtually 100% specific for malignancy in mesothelial proliferations. This specificity makes the assay a critical tool for confirming mesothelioma when paired with mesothelial lineage markers, such as WT1 and calretinin. Combined with MTAP and Claudin-4 tests, the assay provides clinical laboratories with a targeted panel to differentiate malignant mesothelioma from benign and metastatic mimics.
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