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Roche Secures FDA Approval for Advanced Diagnostic Test to Enhance B-cell Lymphoma Diagnosis

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Roche’s Innovative Test for B-cell Lymphoma Gains FDA Approval

  • The VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail assay is the first FDA-approved in-situ hybridization (ISH) test capable of detecting all B-cell lymphoma subtypes.1,2
  • This test distinguishes B-cell cancer from normal immune responses, providing clarity for healthcare professionals and their patients.
  • B-cell lymphoma constitutes about 85 percent of non-Hodgkin lymphoma (NHL) cases, a leading cancer type in the US.3

TUCSON, Ariz., Jan. 13, 2025 /PRNewswire/ — Roche (RO ROG,RHHBY has secured 510(k) clearance from the United States Food and Drug Administration (FDA) for its sensitive in-situ hybridization (ISH) test, the VENTANA® Kappa and Lambda Dual ISH mRNA Probe Cocktail.4 This test aids pathologists in distinguishing between a B-cell malignancy and a normal immune response, allowing for quicker treatment initiation.4 This clearance follows the assay’s CE Mark approval in June 2024.

VENTANA® Kappa and Lambda Dual ISH mRNA Probe Cocktail

B-cell lymphoma primarily arises in the lymphatic system and comprises roughly 85 percent of NHL cases.3 NHL ranks among the most prevalent cancers in the US, making up about 4% of all cancer cases,5 and is responsible for over 80,000 deaths annually.5 Early symptoms of NHL may include swollen lymph nodes, fever, fatigue, loss of appetite, or a red rash.

“Accurate differentiation between lymphoma and infections is essential for timely diagnosis, as symptoms can be misleading,” stated Jill German, Head of Pathology Lab at Roche Diagnostics. “With this innovative test, clinicians can confidently make a diagnosis, which reduces the need for multiple samples and follow-up tests. This ensures that patients receive timely treatment.”

The VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail provides heightened sensitivity, enabling analysis of over 60 B-cell lymphoma subtypes and plasma cell neoplasms from a single tissue slide. This approach facilitates the evaluation of small biopsies and preserves formalin-fixed tissue, alleviating the need for fresh samples, which may not be readily available if lymphoma is initially unanticipated. The test’s efficiency may reduce the incidence of additional patient biopsies and streamline the interpretation process for pathologists, promoting swift diagnosis and timely treatment.

This groundbreaking assay contributes significantly to Roche’s robust hematopathology portfolio, which features over 65 biomarkers.

About the VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail
This qualitative assay detects kappa and lambda immunoglobulin light chains in formalin-fixed paraffin-embedded (FFPE) human hematolymphoid samples through in situ hybridization (ISH).

The assay aids in diagnosing mature B-cell lymphomas and plasma cell neoplasms. It is particularly useful when lymph node or bone marrow biopsies yield inconclusive results. This dual-probe assay allows for combined assessment of both markers on a single slide, assisting in differentiating between a reactive condition and B-cell lymphoma.

It is important to note that this test should be interpreted by a qualified pathologist, taking into account the patient’s clinical history and other diagnostic findings. The product is strictly for in vitro diagnostic (IVD) use.4

About Roche
Founded in 1896 in Basel, Switzerland, Roche has grown to be the world’s largest biotechnology company and the leader in in-vitro diagnostics. The company is dedicated to scientific excellence to create medicines and diagnostics that improve and save lives globally. Roche is also a pioneer in personalized healthcare, aiming to transform healthcare delivery for greater impact. Through collaboration with various partners, the company merges its expertise in Diagnostics and Pharma with data insights from clinical practice.

For over 125 years, sustainability has played a vital role in Roche’s mission. As a science-driven company, its primary contribution is the development of innovative products that promote healthier living. Roche is committed to the Science Based Targets initiative and aims for net-zero emissions by 2045.

Genentech, located in the United States, is a subsidiary of the Roche Group. Additionally, Roche holds a majority stake in Chugai Pharmaceutical in Japan.

For further details, please visit www.roche.com.

All trademarks mentioned are protected by law.

Roche’s New FDA-Cleared Test Set to Improve B-Cell Lymphoma Diagnosis

Roche has received FDA clearance for a new highly-sensitive test aimed at assisting clinicians in diagnosing B-cell lymphoma, a type of non-Hodgkin lymphoma. This innovative testing approach is expected to enhance diagnostic accuracy and patient care.

References

1Rimsza 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.
2F. Hoffmann-La Roche Ltd. Conjoint Market Research. [Survey; Cited 2024 April 4]. Data on file.
3American Cancer Society. Types of B-cell Lymphoma. [Internet; Cited 3 December 2024]. Available at: https://www.cancer.org/cancer/types/non-hodgkin-lymphoma/about/b-cell-lymphoma.html#:~:text=B%2Dcell%20lymphomas%20make%20up,cell%20lymphomas%20are%20listed%20below.
4F. Hoffmann-La Roche Ltd. VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail. [Method Sheet; Cited 2025 January 10]. Data on file.
5American Cancer Society. Key Statistics for Non-Hodgkin Lymphoma. [Internet; Cited 3 December 2024]. Available at: https://www.cancer.org/cancer/types/non-hodgkin-lymphoma/about/key-statistics.html#:~:text=Non%2DHodgkin%20lymphoma%20(NHL),11%2C780%20males%20and%208%2C360%20females).

Roche Media Relations
Jo Lynn Garing, +1 317-363-7286

Roche (PRNewsfoto/Roche)

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SOURCE Roche

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