Roche Launches CE-Marked VENTANA Kappa and Lambda Dual ISH mRNA Probe for B-Cell Lymphoma Diagnosis

Roche has introduced the VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail assay, the first clinically approved, highly sensitive in-situ hybridisation (ISH) test, in countries accepting the CE Mark. This innovative test aids pathologists in distinguishing B-cell malignancies from normal reactive responses to infections.

B-cell lymphoma, a cancer typically developing in the lymphatic system, constitutes approximately 85% of non-Hodgkin lymphoma (NHL) cases. NHL is the tenth most common cancer globally, with over 250,000 annual deaths. Early symptoms of NHL, such as lymph node swelling, fever, fatigue, loss of appetite, or a red rash, can mimic the body’s response to infections.

The VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail assay offers increased sensitivity, enabling assessment across over 60 B-cell lymphoma subtypes and plasma cell neoplasms on a single tissue slide. The test’s ability to assess small biopsies and formalin-fixed tissue reduces the need for fresh samples, which are often unavailable if lymphoma was not initially suspected. These properties help preserve tissue, reduce the need for additional patient biopsies, and facilitate quicker, easier interpretation for pathologists, leading to faster diagnoses and access to treatment.

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As reported by Medical Dialogues, this assay is intended for the qualitative detection of Kappa mRNA and Lambda mRNA in formalin-fixed, paraffin-embedded (FFPE) human bone marrow and lymphoid tissue. The assay is performed on a BenchMark IHC/ISH instrument using chromogenic in-situ hybridisation and visualized via light microscopy. It aids in identifying B-cell lymphomas and plasma cell neoplasms, with results to be interpreted by qualified pathologists alongside histological examination and relevant clinical information.