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Roche Introduces Highly Sensitive Test for Simplified B-Cell Lymphoma Diagnosis

NextEdge Admin

20 Jun 2024

2 min 27 sec

Diagnostic,chromogenic in-situ hybridisation

Roche has unveiled a pioneering diagnostic tool, the VENTANA® Kappa and Lambda Dual ISH mRNA Probe Cocktail assay, approved under the CE Mark, aimed at distinguishing B-cell malignancies from reactive responses to infections. This breakthrough addresses the challenge in diagnosing B-cell lymphoma, a prevalent form of non-Hodgkin lymphoma (NHL) that affects the lymphatic system.

B-cell lymphoma constitutes about 85% of NHL cases and ranks among the top ten most common cancers worldwide, claiming over 250,000 lives annually. Symptoms such as lymph node swelling, fever, fatigue, and rash can mimic benign immune responses, underscoring the need for precise diagnostic tools.

Matt Sause, CEO of Roche Diagnostics, emphasized the assay's role in providing definitive diagnoses crucial for timely treatment decisions. The assay's heightened sensitivity allows comprehensive evaluation of over 60 B-cell lymphoma subtypes and plasma cell neoplasms from a single tissue sample. This capability is particularly beneficial for assessing small biopsies or formalin-fixed tissues, reducing reliance on fresh samples that may be unavailable post-diagnosis.

The assay operates on the VENTANA BenchMark IHC/ISH platform, utilizing chromogenic in-situ hybridisation (ISH) to detect Kappa mRNA and Lambda mRNA in formalin-fixed, paraffin-embedded human tissues. This method enhances diagnostic accuracy and preserves tissue integrity, potentially reducing the need for additional biopsies.

Roche's hematopathology portfolio, renowned for its extensive biomarker offerings, now includes this innovative assay designed to aid pathologists in diagnosing B-cell lymphomas and plasma cell neoplasms. Interpretation of assay results requires collaboration between pathologists, histological examination, clinical data, and appropriate controls.