Roche Launches Advanced Diagnostic Test for B-Cell Lymphoma Detection

Roche Launches Advanced Diagnostic Test for B-Cell Lymphoma Detection

(IN BRIEF) Roche has introduced the VENTANA® Kappa and Lambda Dual ISH mRNA Probe Cocktail assay, the first clinically approved in-situ hybridisation (ISH) test of its kind. Designed to enhance sensitivity in diagnosing B-cell lymphoma, the assay helps differentiate cancerous cells from normal immune responses, providing crucial diagnostic certainty. B-cell lymphoma accounts for a significant majority of non-Hodgkin lymphoma (NHL) cases globally. This innovative assay allows comprehensive assessment across more than 60 B-cell lymphoma subtypes on a single tissue slide, using small biopsies and formalin-fixed tissues. It aims to streamline diagnostics, potentially reducing the need for additional biopsies and expediting treatment decisions for patients.

This launch underscores Roche’s commitment to advancing hematopathology and expanding diagnostic capabilities in oncology, reinforcing its leadership in the field.

(PRESS RELEASE) BASEL, 20-Jun-2024 — /EuropaWire/ — Roche (SIX: RO, ROG; OTCQX: RHHBY) has introduced the VENTANA® Kappa and Lambda Dual ISH mRNA Probe Cocktail assay, marking a milestone as the first clinically approved in-situ hybridisation (ISH) test of its kind. Designed for countries accepting the CE Mark, this innovative assay sets a new standard in diagnosing B-cell lymphoma by providing enhanced sensitivity to differentiate cancerous cells from normal immune responses.

B-cell lymphoma constitutes a significant portion of non-Hodgkin lymphoma (NHL), accounting for about 85% of cases globally. Recognizing the challenges in distinguishing lymphoma from benign conditions, Roche’s new assay aims to deliver precise diagnostic certainty crucial for timely patient management.

Matt Sause, CEO of Roche Diagnostics, emphasized the assay’s importance in providing definitive diagnoses amid symptoms that can mimic benign immune responses. The assay’s high sensitivity allows comprehensive assessment of over 60 B-cell lymphoma subtypes and plasma cell neoplasms on a single tissue slide, using small biopsies and formalin-fixed tissues.

This advancement not only preserves tissue samples but also streamlines the diagnostic process, potentially reducing the need for additional biopsies and accelerating patient access to appropriate treatments. Roche’s launch underscores its commitment to advancing hematopathology and expanding diagnostic capabilities in oncology.

The VENTANA® Kappa and Lambda Dual ISH mRNA Probe Cocktail assay represents a significant addition to Roche’s robust portfolio of over 65 biomarkers, reaffirming its leadership in hematology diagnostics.

About the VENTANA Kappa and Lambda 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.4

About Roche
Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice.

In recognising our endeavour to pursue a long-term perspective in all we do, Roche has been named one of the most sustainable companies in the pharmaceuticals industry by the Dow Jones Sustainability Indices for the fifteenth consecutive year. This distinction also reflects our efforts to improve access to healthcare together with local partners in every country we work.

Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.

For more information, please visit www.roche.com.

All trademarks used or mentioned in this release are protected by law.

References
[1] Rimsza LM, et al. Kappa and lambda light chain mRNA in situ hybridization compared to flow cytometry and immunohistochemistry in B cell lymphomas. Diagn Pathol. 2014;9:144.
[2] F. Hoffmann-La Roche Ltd. Conjoint Market Research. [Survey; Cited 2024 April 4]. Data on File.
[3] Global Cancer Observatory. Non-Hodgkin Lymphoma Fact Sheet [Internet; Cited 11 April 2024]. Available from: https://gco.iarc.who.int/media/globocan/factsheets/cancers/34-non-hodgkin-lymphoma-fact-sheet.pdf
[4] F. Hoffmann-La Roche Ltd. VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail. [Method Sheet; cited 2024 April 16]. Data on file.

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SOURCE: ROCHE