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Roche Secures FDA Clearance for VENTANA® Kappa and Lambda Dual ISH mRNA Probe Cocktail to Enhance B-Cell Lymphoma Diagnosis

NextEdge Admin

14 Jan 2025

2 min 38 sec

Roche has received FDA 510(k) clearance for its VENTANA® Kappa and Lambda Dual ISH mRNA Probe Cocktail, a highly sensitive in-situ hybridization (ISH) test. This test helps pathologists differentiate B-cell malignancies from reactive infections, facilitating faster diagnosis and treatment. It follows the assay’s CE Mark approval in June 2024.

B-cell lymphoma, a cancer of the lymphatic system, accounts for about 85% of non-Hodgkin lymphoma (NHL) cases. NHL is among the most common cancers in the U.S., responsible for roughly 4% of cases and over 80,000 deaths annually. Early symptoms include lymph node swelling, fever, fatigue, appetite loss, and skin rashes.

“Accurately distinguishing lymphoma from infection is crucial for timely diagnosis,” said Jill German, Head of Pathology Lab at Roche Diagnostics. “This test minimizes the need for multiple samples and follow-ups, enabling faster access to appropriate treatment.”

The VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail assesses over 60 B-cell lymphoma subtypes and plasma cell neoplasms using a single tissue slide. It is designed for small biopsies and formalin-fixed tissues, preserving samples and reducing the need for fresh biopsies. These properties streamline interpretation, reducing additional procedures and expediting diagnosis.

Part of Roche’s comprehensive hematopathology portfolio, which includes over 65 biomarkers, this first-of-its-kind assay enhances diagnostic accuracy. It detects kappa and lambda immunoglobulin light chain expression in formalin-fixed paraffin-embedded (FFPE) hematolymphoid specimens, aiding in differentiating reactive processes from B-cell lymphomas and plasma cell neoplasms.

The test is not standalone; results must be interpreted by a qualified pathologist in conjunction with clinical history and other diagnostic tests. It is intended for in vitro diagnostic (IVD) use.