RSS Roche's New Test For B-Cell Lymphoma Obtains FDA Clearance

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 RSS Roche's New Test For B-Cell Lymphoma Obtains FDA Clearance

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Roche (RHHBY) announced on Monday that it has obtained 510(k) clearance from the U.S. Food and Drug Administration for its advanced in-situ hybridization (ISH) test, the VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail. This test is designed to assist pathologists in distinguishing between B-cell malignancy and a normal, reactive response to an infection, thereby enabling quicker access to necessary treatment. This clearance follows the assay's prior CE Mark approval in June 2024.

B-cell lymphoma, a cancer predominantly developing in the lymphatic system, represents approximately 85% of non-Hodgkin lymphoma (NHL) cases.

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