Core Message - Roche has received FDA 510(k) clearance for its VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail, a highly sensitive test designed to differentiate B-cell malignancies from normal immune responses, facilitating faster treatment access [4][6][8] Product Details - The VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail is the first clinically approved ISH test capable of assessing the full spectrum of B-cell lymphoma subtypes [6] - The test can evaluate over 60 B-cell lymphoma subtypes and plasma cell neoplasms on a single tissue slide, reducing the need for multiple samples and follow-up tests [8] - It is designed to detect kappa and lambda immunoglobulin light chains in formalin-fixed paraffin-embedded human hematolymphoid specimens [10] - The assay aids in diagnosing mature B-cell lymphomas and plasma cell neoplasms, particularly when biopsy results are inconclusive [11] Market and Industry Context - B-cell lymphoma accounts for approximately 85% of non-Hodgkin lymphoma (NHL) cases, which is one of the most common cancers in the US, representing about 4% of all cancer cases and causing over 80,000 deaths annually [6][7] - The test is a significant addition to Roche's hematopathology portfolio, which includes more than 65 biomarkers [9] Company Background - Roche, founded in 1896, is the world's largest biotechnology company and a global leader in in-vitro diagnostics [12] - The company is committed to sustainability, aiming for net zero by 2045 through initiatives like the Science Based Targets and Sustainable Markets Initiative [13]
Roche receives FDA clearance for new, highly-sensitive test to aid clinicians in diagnosing B-cell lymphoma