Roche has secured FDA 510(k) clearance for its VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail, a highly sensitive in-situ hybridization (ISH) test designed to aid in the diagnosis of B-cell lymphoma. This test assists pathologists in differentiating between a B-cell malignancy and a normal, reactive response to an infection, potentially expediting access to necessary treatment for patients. The clearance follows the assay's CE Mark approval received in June 2024.
Significance in B-Cell Lymphoma Diagnosis
B-cell lymphoma, a cancer originating in the lymphatic system, constitutes approximately 85% of non-Hodgkin lymphoma (NHL) cases. Accurate and timely diagnosis is critical for effective treatment planning and improved patient outcomes. The VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail offers a refined method for identifying B-cell malignancies, addressing a key challenge in diagnostic pathology.
How the Test Works
The VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail is designed to detect kappa and lambda light chain mRNA within B-cells. In reactive or normal conditions, B-cells exhibit a diverse population of both kappa and lambda light chains. However, in B-cell lymphomas, there is typically a monoclonality, meaning a dominance of either kappa or lambda light chains. The test uses in-situ hybridization to visualize these mRNA molecules within tissue samples, allowing pathologists to identify this monoclonality and distinguish malignant from benign conditions.
Impact on Treatment
By providing a more precise method for distinguishing between malignant and reactive B-cell populations, the VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail can help reduce diagnostic uncertainty. This can lead to quicker and more appropriate treatment decisions, potentially improving outcomes for patients with B-cell lymphoma. The availability of this test represents a significant advancement in diagnostic tools for hematological malignancies.
