Roche launches VENTANA BAP1 test to improve mesothelioma diagnosis

Roche announced the global launch of its VENTANA BAP1 (SP527) test, an automated ready‑to‑use immunohistochemistry assay designed for differential diagnosis of mesothelioma.

The assay targets the BAP1 tumor suppressor protein, a biomarker that helps pathologists distinguish mesothelioma from other cancers such as non‑small cell lung cancer, while preserving limited tissue samples.

The test is registered with the FDA as a Class I in‑vitro diagnostic device and has received IVDR approval as a Class C device in Europe, meeting regulatory standards in both markets.

Roche says the high specificity of the BAP1 assay can reduce the need for extensive antibody panels, leaving more tissue available for molecular sequencing and precision‑medicine testing.