Medical Device Network

Roche launches B-cell lymphoma diagnostic assay in Europe

Roche’s Ventana B-cell lymphoma diagnostic assay can detect and differentiate B-cell lymphomas and plasma cell neoplasms from a normal immune response.

Roche has launched an in vitro diagnostic assay, Ventana Kappa and Lambda Dual ISH mRNA Probe Cocktail assay, in countries that accept the EU CE mark.

The Ventana B-cell lymphoma diagnostic assay is designed to qualitatively detect Kappa mRNA and Lambda mRNA. The test detects the presence of B-cell lymphomas and plasma cell neoplasms in formalin-fixed, paraffin-embedded (FFPE) human bone marrow and lymphoid tissue.

B-cell lymphoma occurs when some lymphocytes are no longer healthy enough to fight infection. These, in turn, grow out of control and become cancerous and may spread to other organs. One of the most common types of B-cell cancer is Non-Hodgkin Lymphoma, which has an annual age-standardised incidence rate of 5.8 per 100,000 population, per a 2024 study.

The increased sensitivity of the test allows for the assessment of more than 60 subtypes of B-cell lymphoma and plasma cell neoplasms on a single tissue slide. The test can also be performed on small biopsies and formalin-fixed tissue, thereby reducing the need for a fresh tissue sample, which may not be available, especially if lymphoma was not originally suspected.

GlobalData estimates that the market for in vitro diagnostics will grow to more than $35.6bn by 2033. Rapid diagnostics have also increased in popularity, especially following the Covid-19 pandemic.

In April, Roche secured a CE mark for the companion diagnostic, Ventana HER2 (4B5) Rabbit Monoclonal Primary Antibody RxDx, for Daiichi Sankyo and AstraZeneca’s Enhertu (trastuzumab deruxtecan). The test can be used to identify patients with low human epidermal growth factor receptor 2 (HER2) expression. These low HER2 patient patients can best benefit from Enhertu, which has been approved in the EU for the treatment of HER2-positive advanced non-small cell lung cancer (NSCLC), breast cancer – either HER2-positive or HER2-low and HER2-positive gastroesophageal junction adenocarcinoma.

Roche’s blood test portfolio includes multiple immunoassays such as Elecsys HBeAg quant to diagnose and monitor hepatitis B, Anti-HEV IgM and Elecsys Anti-HEV IgG immunoassays for detecting hepatitis E virus (HEV) infections, neurofilament light chain (NfL) test for diagnosing multiple sclerosis and interleukin 6 (IL-6) immunoassays for diagnosing neonatal sepsis.