Roche gets FDA 510(k) clearance for B-cell lymphoma assay

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Roche announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its assay designed to aid in the diagnosis of B-cell lymphoma.

The Ventana Kappa and Lambda Dual ISH mRNA Probe Cocktail is an in situ hybridization test designed to help pathologists differentiate a B-cell malignancy from a reactive response to an infection, the firm said in a statement.

The FDA clearance follows the assay receiving the CE Mark in June 2024. B-cell lymphoma, which usually develops in the lymphatic system, accounts for approximately 85% of cases of non-Hodgkin lymphoma.

The test offers assessment across more than 60 B-cell lymphoma subtypes and plasma cell neoplasms on one slide. According to Roche, it can assess small biopsies and formalin-fixed tissue, therefore reducing the need for additional biopsies, especially in cases where B-cell lymphoma was not initially suspected.

The Ventana Kappa and Lambda Dual ISH mRNA Probe Cocktail is indicated for use when a biopsy of lymph node or bone marrow biopsy yields inconclusive results. The assay is intended as an aid in the diagnosis of mature B-cell lymphomas and plasma cell neoplasms; it is not a standalone test, and results must be evaluated in conjunction with other diagnostic tests and clinical history, Roche noted.

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