Roche launches VENTANA BAP1 test to support mesothelioma diagnosis

Roche has launched its VENTANA BAP1 (SP527) test globally to help pathologists distinguish malignant mesothelioma from other cancers and benign tissue growths.

The automated immunohistochemistry assay is designed to detect loss of nuclear BAP1 expression, a tumour suppressor marker associated with malignant mesothelial proliferations.

Roche said the test can help differentiate mesothelioma from malignancies including non-small cell lung cancer, breast cancer and stomach cancer, as well as from benign tissue changes in the chest and abdomen.

The assay is registered as a Class I in vitro diagnostic device with the U.S. Food and Drug Administration and has also received Class C approval under the European Union’s In Vitro Diagnostic Regulation.

Mesothelioma is a rare and aggressive cancer that develops in the tissue lining internal organs.

More than 80% of cases occur in the pleural cavity surrounding the lungs.

The disease is often diagnosed at an advanced stage, with Roche citing a median overall survival of around 12 to 18 months.

Matt Sause, Chief Executive Officer of Roche Diagnostics, said improving the speed and accuracy of differential diagnosis is important for guiding treatment decisions in patients with suspected mesothelioma.

He said the addition of the BAP1 assay expands Roche’s diagnostic portfolio for cancers with significant unmet clinical need.

One challenge in diagnosing lung cancer and mesothelioma is the limited amount of tissue available from patient samples.

Traditional diagnostic approaches can require large antibody panels, potentially using up tissue that may also be needed for molecular sequencing and other precision medicine tests.

Roche said highly specific individual markers such as BAP1 can help reduce tissue consumption while still supporting accurate diagnosis.

The new assay is intended to work alongside Roche’s recently launched VENTANA MTAP (SP530) and VENTANA Claudin-4 (EP417) tests.

Together, the assays are designed to help distinguish malignant mesothelioma from benign mesothelial proliferations and metastatic cancers.

VENTANA BAP1 uses a rabbit monoclonal antibody to identify loss of nuclear BAP1 expression.

Roche said loss of nuclear BAP1 detected by immunohistochemistry is almost 100% specific for malignancy in mesothelial proliferations when interpreted alongside established mesothelial markers such as WT1 and calretinin.

The test joins Roche’s broader lung cancer diagnostic portfolio, which includes immunohistochemistry assays for biomarkers such as ALK, PD-L1 and MET, alongside molecular diagnostics, next-generation sequencing and digital diagnostic tools.

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