Roche has announced the launch of the first clinically approved, highly-sensitive in-situ hybridization (ISH) test for B-cell lymphoma, the VENTANA® Kappa and Lambda Dual ISH mRNA Probe Cocktail assay. This test, now available in countries accepting the CE Mark, helps pathologists differentiate B-cell malignancies from normal, reactive immune responses. This new test is particularly crucial as B-cell lymphoma accounts for approximately 85 percent of non-Hodgkin lymphoma (NHL) cases, which is the tenth most common cancer worldwide.
The VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail assay offers increased sensitivity, enabling the assessment of over 60 B-cell lymphoma subtypes and plasma cell neoplasms on a single tissue slide. This test can analyze small biopsies and formalin-fixed tissues, reducing the need for fresh tissue samples, which is especially beneficial if lymphoma is not initially suspected. By preserving tissue and potentially decreasing the need for additional biopsies, this assay makes diagnosis faster and more accurate, facilitating quicker access to treatment for patients.
Roche’s VENTANA Test Revolutionizes Detection of B-cell Lymphoma
B-cell lymphoma, a type of cancer that develops in the lymphatic system, can often present symptoms similar to a normal reactive response to infection, such as swelling of the lymph nodes, fever, and fatigue. The new test provides diagnostic certainty, helping healthcare providers distinguish between a malignancy and a benign reactive response. According to Matt Sause, CEO of Roche Diagnostics, this highly sensitive assay significantly improves the diagnostic process for patients with suspected B-cell lymphoma.
The VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail is intended for the qualitative detection of Kappa and Lambda mRNA in formalin-fixed, paraffin-embedded human bone marrow and lymphoid tissue. It is stained using a BenchMark IHC/ISH instrument with chromogenic ISH and visualized via light microscopy. This assay aids in identifying B-cell lymphomas and plasma cell neoplasms, with results interpreted by qualified pathologists alongside histological examination and relevant clinical information. The test is designed for in vitro diagnostic use.
Roche Enhances Diagnostic Precision with Innovative Assay in Hematopathology Portfolio
This assay is a significant addition to Roche’s hematopathology portfolio, which includes over 65 biomarkers. It underscores Roche’s commitment to providing innovative diagnostic solutions that enhance the accuracy and speed of diagnoses. The company continues to lead in biotechnology and in-vitro diagnostics, pioneering personalized healthcare and transforming healthcare delivery to improve patient outcomes globally.
Founded in 1896 in Basel, Switzerland, Roche is the world’s largest biotechnology company and a leader in in-vitro diagnostics. Roche is committed to scientific excellence, aiming to discover and develop medicines and diagnostics that improve and save lives. The company partners with numerous stakeholders to combine its strengths in Diagnostics and Pharma with data insights from clinical practice, promoting personalized healthcare. Roche has been recognized as one of the most sustainable companies in the pharmaceuticals industry by the Dow Jones Sustainability Indices for fifteen consecutive years.
Resource: Roche, June 20, 2024
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