Roche has announced the global launch of the VENTANA BAP1 (SP527) test, an automated, ready-to-use immunohistochemistry (IHC) assay designed to help pathologists identify malignant mesothelioma and distinguish it from other cancers, including non-small cell lung cancer (NSCLC).
The assay is registered as a Class I in vitro diagnostic (IVD) device with the US Food and Drug Administration (FDA) and has received approval under the In Vitro Diagnostic Regulation (IVDR) as a Class C device. It is available globally.
Mesothelioma is a rare, deadly cancer that develops in the mesothelium, the tissue lining many internal organs. Roche cited that more than 80 per cent 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.
Mesothelioma is often diagnosed at an advanced stage, resulting in a median overall survival of just 12 to 18 months.
“Timely differential diagnosis of mesothelioma is critical to help deliver the best outcome for patients,” said Matt Sause, CEO of Roche Diagnostics.
According to Roche, a major challenge in diagnosing lung cancer and mesothelioma is preserving limited patient tissue samples for multiple tests. Traditional diagnostic approaches may exhaust tissue blocks through extensive antibody panels, leaving insufficient material for molecular sequencing and precision medicine testing.
Highly specific markers such as BAP1 (SP527), alongside Roche’s recently launched VENTANA MTAP (SP530) and VENTANA Claudin-4 (EP417) assays, can help pathologists differentiate malignant mesothelioma from other malignancies and benign conditions while minimising tissue loss. This can help preserve samples for essential downstream molecular testing.
The VENTANA BAP1 (SP527) Rabbit Monoclonal Primary Antibody is designed for automated IHC testing to detect the loss of nuclear BAP1 expression. BAP1 is a tumour suppressor protein encoded by a gene located on chromosome 3p21.
The loss of nuclear BAP1 expression is highly specific for malignancy in mesothelial proliferations. When used alongside mesothelial lineage markers such as WT1 and calretinin, the assay can help confirm a diagnosis of mesothelioma.
Roche added that BAP1 combined with the MTAP and Claudin-4 assays can further support the differentiation of malignant mesothelioma from benign and metastatic mimics.
The test can help distinguish malignant mesothelioma from lung, breast and gastric cancers, as well as benign tissue growths in the chest or abdomen.
