Roche has announced the global launch of the VENTANA BAP1 (SP527) test. This automated, ready-to-use immunohistochemistry (IHC) assay provides a reliable, highly specific diagnostic tool to help clinicians and pathologists accurately identify mesothelioma and distinguish it from other malignancies, including non-small cell lung cancer (NSCLC).
The BAP1 assay is registered as a Class I IVD with US Food and Drug Administration, has received IVDR approval as a Class C device, and is available globally.
BAP1 pinpoints malignant mesothelioma, a deadly, rare cancer that forms in the tissue that lines many internal organs. More than 80% of mesothelioma cases are found in the pleural cavity, an area of thin fluid-filled space between the two layers of tissue that surround each lung.
“Timely differential diagnosis of mesothelioma is critical to help deliver the best outcome for patients,” said Matt Sause, CEO of Roche Diagnostics. “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.”
A major challenge in lung cancer and mesothelioma diagnostics is the preservation of limited patient tissue samples. Traditional approaches can exhaust tissue blocks through extensive antibody panels. Single markers with high specificity, such as BAP1 (SP527), along with the recently launched VENTANA MTAP (SP530) and VENTANA Claudin-4 (EP417) tests, allow pathologists to accurately differentiate cancers while minimising tissue loss. By optimising sample management, clinicians ensure sufficient tissue remains for essential molecular sequencing and precision medicine testing.
Lung cancer is the leading cause of cancer death worldwide. Every year, more than 2.5 million people are diagnosed with lung cancer globally and up to 85% of these cases are NSCLC.
Roche's comprehensive lung cancer diagnostic portfolio delivers end-to-end clinical answers across the patient pathway. The portfolio spans advanced tissue diagnostics, including foundational H&E staining and high-medical-value IHC assays like ALK (D5F3), PD-L1 (SP263) and MET (SP44) to core laboratory immunoassays, molecular diagnostics (oncology PCR and CGP/NGS) and navify digital software.
Launching assays like BAP1 (SP527) alongside Roche’s existing portfolio helps address unmet clinical needs and bridge diagnostic gaps to enable more effective patient management. Acting as a powerful force multiplier, BAP1 combines with the newly launched MTAP and Claudin-4 assays to help distinguish malignant mesothelioma from benign and metastatic mimics.
This comprehensive and constantly evolving portfolio empowers medical practitioners to accelerate diagnostic certainty while maximising pre-analytical sample stewardship to preserve precious patient tissue for critical downstream diagnostics like molecular sequencing.
The VENTANA BAP1 (SP527) Rabbit Monoclonal Primary Antibody is designed for automated IHC testing to detect nuclear loss of BAP1 expression, a tumour suppressor marker located on chromosome 3p21. IHC loss of nuclear BAP1 is virtually 100% specific for malignancy in mesothelial proliferations, making it an indispensable tool for confirming mesothelioma in conjunction with mesothelial lineage markers such as WT1 and calretinin.