Roche has 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 is a type of cancer that typically develops in the lymphatic system. It accounts for approximately 85% of non-Hodgkin's 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, loss of appetite or a red rash.
“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.”
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.
This first-of-its-kind assay is a significant addition to Roche’s industry-leading haematopathology portfolio, which includes more than 65 biomarkers.
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 wax-embedded (FFPE) human bone marrow and lymphoid tissue stained on a BenchMark IHC/ISH instrument using chromogenic in situ hybridisation 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.