Roche announced the global launch of its VENTANA BAP1 (SP527) test, an automated, ready-to-use immunohistochemistry (IHC) assay.
The highly specific diagnostic tool is designed 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 the FDA, and has received IVDR approval as a Class C device.
BAP1 functions as a tumor suppressor and a biomarker for malignant mesothelioma, a deadly, rare cancer that forms in the tissue that lines many internal organs. According to the CDC, more than 80 percent of mesothelioma cases originate in the pleura, the membrane surrounding the lungs.
A major hurdle in lung cancer and mesothelioma diagnostics is the lack of patient tissue samples testing professionals must work with. Traditional approaches can exhaust available tissue through extensive antibody panels.
Single, highly specific biomarkers, such as BAP1 (SP527), can help pathologists accurately differentiate cancers while minimising tissue loss, Roche said in a statement.
“By optimising sample management, clinicians can ensure sufficient tissue remains for essential molecular sequencing and precision medicine testing. Timely differential diagnosis of mesothelioma is critical to help deliver the best outcome for patients,” said Matt Sause, CEO of Roche Diagnostics, in a release.
“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.”