Pharma Focus Asia

Roche Launches New Test for Early Detection of B-cell Lymphoma

Thursday, June 20, 2024

Roche (SIX: RO, ROG; OTCQX: RHHBY) has recently launched the VENTANA® Kappa and Lambda Dual ISH mRNA Probe Cocktail assay, the first ISH test approved for clinical use in countries that accept the CE Mark. This assay aids pathologists in distinguishing between B-cell malignancies and normal immune responses to infections.

B-cell lymphoma, which arises in the lymphatic system, constitutes approximately 85% of non-Hodgkin lymphoma (NHL) cases. NHL is the tenth most prevalent cancer worldwide, causing over 250,000 deaths annually. Early NHL symptoms include swollen lymph nodes, fever, fatigue, loss of appetite, and a red rash.

Roche Diagnostics, emphasized the importance of accurate diagnosis: "Providing patients with a definitive diagnosis is crucial, as lymphoma symptoms can mimic normal immune responses to infections." He highlighted the assay's high sensitivity, which ensures diagnostic certainty for suspected B-cell lymphoma cases.

The assay allows evaluation of more than 60 B-cell lymphoma subtypes and plasma cell neoplasms on a single tissue slide. It can analyze small biopsies and formalin-fixed tissue, reducing the need for fresh tissue samples that may not be available, especially if lymphoma was not initially suspected. These features help preserve tissue, potentially reducing the need for additional biopsies, and simplifying interpretation for pathologists, leading to faster diagnosis and treatment for patients.

The VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail is a significant addition to Roche’s hematopathology portfolio, which includes over 65 biomarkers.

This assay is intended for the qualitative detection of Kappa and Lambda mRNA in formalin-fixed, paraffin-embedded (FFPE) human bone marrow and lymphoid tissue, processed using chromogenic in-situ hybridisation (ISH) on a BenchMark IHC/ISH instrument, and visualized with light microscopy. It assists in identifying B-cell lymphomas and plasma cell neoplasms, with results interpreted by qualified pathologists alongside histological examination, clinical data, and appropriate controls. This product is for in vitro diagnostic (IVD) use.



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