Roche Launches VENTANA BAP1 Test, Adding A Mesothelioma Diagnostic With FDA And IVDR Status

Roche said it has launched its VENTANA BAP1 (SP527) test globally, expanding its diagnostics portfolio with an automated, ready-to-use immunohistochemistry assay aimed at mesothelioma. The company said the assay is designed to help clinicians and pathologists identify the cancer accurately and distinguish it from other malignancies, including non-small cell lung cancer.

The release is a commercial diagnostics story as much as a technical one. Roche is targeting a narrow but difficult workflow problem in thoracic pathology, where limited tissue can force trade-offs between reaching a diagnosis and preserving sample for later molecular work.

Why Roche is positioning the test this way

BAP1 functions as a tumor suppressor and as a biomarker for malignant mesothelioma, a rare and deadly cancer that forms in the tissue lining many internal organs. Roche cited CDC data showing that more than 80 percent of mesothelioma cases originate in the pleura, the membrane surrounding the lungs.

According to Roche, one of the main hurdles in diagnosing lung cancer and mesothelioma is the lack of patient tissue samples available to testing professionals. Traditional diagnostic approaches can consume that material through extensive antibody panels. Roche said a single, highly specific biomarker such as BAP1 (SP527) can help pathologists differentiate cancers while minimizing tissue loss.

That positioning gives the test a clearer value proposition than novelty alone. If a laboratory can reach a differential diagnosis with less tissue consumption, more sample may remain available for molecular sequencing and precision medicine testing, which Roche highlighted in its launch statement.

Regulatory and market position

Roche said the BAP1 assay is registered as a Class I IVD with the FDA and has received IVDR approval as a Class C device. Those statuses support a global launch message built around deployment readiness rather than a future regulatory milestone.

Matt Sause, CEO of Roche Diagnostics, said timely differential diagnosis of mesothelioma is critical to help deliver the best outcome for patients. For Roche, the test adds a product tied to an area of high unmet need while also fitting a broader diagnostics strategy centered on workflow efficiency, sample preservation, and keeping patients eligible for downstream precision testing.