SOUTH SAN FRANCISCO (dpa-AFX) - Roche (RHHBY) has launched a new diagnostic test designed to help distinguish malignant mesothelioma, a rare cancer affecting the lining of internal organs, from other cancers and benign tissue growths.
Mesothelioma most commonly affects the pleura, the tissue lining around the lungs. Diagnosis can be challenging because the disease may resemble other cancers, including non-small cell lung cancer, as well as non-cancerous tissue growths. Many patients are diagnosed at an advanced stage, when median overall survival is approximately 12 to 18 months.
The VENTANA BAP1 (SP527) test is an automated immunohistochemistry (IHC) assay that detects the loss of BAP1 protein expression in cell nuclei, a finding that can help pathologists identify malignant mesothelioma. The test is designed to support diagnosis while helping preserve limited tissue samples for additional testing, including molecular analysis that can guide treatment decisions.
Roche said the test is registered as a Class I in vitro diagnostic in the U.S. and has received Class C approval under the European Union's In Vitro Diagnostic Regulation (IVDR). It is available globally.
The launch expands Roche's cancer diagnostics portfolio, which includes tissue-based tests, molecular diagnostics, laboratory immunoassays and digital diagnostic software. The company said the BAP1 test can be used alongside its VENTANA MTAP and Claudin-4 assays to help distinguish mesothelioma from other conditions.
RHHBY has traded between $40.07 and $61.49 over the past year. The stock closed Tuesday's trading at $60.37, up 0.65%.
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