• 21 Jun 2024
• Admin
• News Article

Roche Introduces VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail Assay

Roche introduces VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail assay, a new highly-sensitive test to more easily diagnose patients who may have B-cell lymphoma

Overview

Roche announced the launch of the first clinically approved, highly-sensitive in-situ hybridisation (ISH) test, the VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail assay, in countries accepting the CE Mark. The test is designed to help pathologists differentiate a B-cell malignancy from a normal, reactive response to an infection.

B-cell lymphoma

• B-cell lymphoma is a type of cancer that typically develops in the lymphatic system. 
• It accounts for approximately 85 per cent of non-Hodgkin lymphoma (NHL) cases. 
• NHL is the tenth most common cancer worldwide and each year more than 250,000 people die from this disease. 
• In the early stages of NHL, patients may experience symptoms like swelling of the lymph nodes, fever, fatigue, and loss of appetite or a red rash.

Words from CEO: Roche Diagnostics

• “It’s important to be able to provide patients with a definitive diagnosis as symptoms of lymphoma can appear similar to the body’s normal reactive response to an infection,” said Matt Sause, CEO of Roche Diagnostics. 
• “This highly sensitive assay offers diagnostic certainty for patients with suspected B-cell lymphoma.”

About the New Test

• With increased sensitivity, the new test enables assessment across the more than 60 B-cell lymphoma subtypes and plasma cell neoplasms on a single tissue slide. 
• The test can assess small biopsies and formalin-fixed tissue, reducing the need for a fresh tissue sample, which may not be available especially if lymphoma was not originally suspected. 
• These test properties preserve tissue, may result in fewer additional patient biopsies and make interpretation quicker and easier for the pathologist, helping create a faster diagnosis and access to treatment for patients.

First-of-its’s-kind Assay

This first-of-its-kind assay is a significant addition to Roche’s industry-leading hematopathology portfolio, which includes more than 65 biomarkers.

Dual ISH mRNA Probe Cocktail

• VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail is intended for the qualitative detection of Kappa mRNA and Lambda mRNA in formalin-fixed, paraffin-embedded (FFPE) human bone marrow and lymphoid tissue stained on a BenchMark IHC/ISH instrument using chromogenic in-situ hybridisation (ISH) and visualised using light microscopy. 
• VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail is intended as an aid in the identification of B-cell lymphomas and plasma cell neoplasms. 
• The results of the assay should be interpreted by a qualified pathologist in conjunction with histological examination, relevant clinical information, and proper controls. 
• This product is intended for in vitro diagnostic (IVD) use.