Roche receives FDA clearance for new, highly-sensitive test to aid clinicians in diagnosing B-cell lymphoma

Rhea-AI Summary

Roche (RHHBY) has received FDA 510(k) clearance for its VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail, a groundbreaking test for diagnosing B-cell lymphoma. This follows its CE Mark approval in June 2024. The test is the first clinically approved in-situ hybridisation (ISH) test capable of assessing all B-cell lymphoma subtypes.

The highly-sensitive test helps distinguish between B-cell cancer and normal immune responses, enabling faster diagnosis and treatment initiation. It can evaluate over 60 B-cell lymphoma subtypes and plasma cell neoplasms on a single tissue slide, working with small biopsies and formalin-fixed tissue. This reduces the need for fresh tissue samples and additional biopsies.

B-cell lymphoma represents about 85% of non-Hodgkin lymphoma (NHL) cases, with NHL being one of the most common cancers in the US, accounting for 4% of all cancer cases and causing over 80,000 deaths annually.

Positive

• FDA 510(k) clearance received for new diagnostic test
• First clinically approved ISH test for full B-cell lymphoma spectrum
• Addresses large market (85% of NHL cases)
• Reduces need for multiple biopsies and follow-up tests
• Expands Roche's hematopathology portfolio

Negative

• None.

Insights

Medical Research Analyst

The FDA clearance of Roche's VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail represents a significant diagnostic advancement in B-cell lymphoma detection. The test's ability to assess over 60 B-cell lymphoma subtypes on a single tissue slide marks a substantial improvement over current diagnostic methods. Key advantages include:

• Enhanced sensitivity for detecting the full spectrum of B-cell lymphoma subtypes
• Reduced need for multiple biopsies and follow-up tests
• Capability to work with small biopsies and formalin-fixed tissue

The clinical implications are substantial, particularly considering that B-cell lymphomas comprise 85% of NHL cases, with NHL accounting for 4% of all US cancer cases. This translates to a sizable market opportunity, as NHL causes over 80,000 deaths annually in the US alone.

Financial Analyst

This FDA clearance strengthens Roche's competitive position in the diagnostic oncology market. The test's first-to-market status for ISH-based B-cell lymphoma detection provides a notable advantage in the $7.3 billion global lymphoma diagnostics market. Market growth drivers include:

• Cost efficiency through reduced need for multiple tests
• Integration with Roche's existing portfolio of 65+ hematopathology biomarkers
• Potential for increased market share in the oncology diagnostics segment

For investors, this approval represents a strategic enhancement to Roche's diagnostics division, which has been a consistent revenue generator. The test's ability to expedite diagnosis and treatment decisions aligns with healthcare providers' focus on improving patient outcomes while managing costs, suggesting strong adoption potential.

• The VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail assay is the first clinically approved in-situ hybridisation (ISH) test with the sensitivity to assess the full spectrum of B-cell lymphoma subtypes.^1,2
• The test helps differentiate a B-cell cancer from a normal, reactive immune response, offering diagnostic certainty for healthcare providers and their patients.
• B-cell lymphoma accounts for approximately 85 percent of non-Hodgkin lymphoma (NHL) cases, which is one of the most common cancers in the US.³

TUCSON, Ariz., Jan. 13, 2025 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for its highly-sensitive in-situ hybridisation (ISH) test, the VENTANA® Kappa and Lambda Dual ISH mRNA Probe Cocktail.⁴ The test is designed to help pathologists differentiate a B-cell malignancy from a normal, reactive response to an infection, thus facilitating faster access to treatment.⁴ This announcement follows the assay's CE Mark approval in June 2024.

B-cell lymphoma is a type of cancer that typically develops in the lymphatic system. It accounts for approximately 85 percent of non-Hodgkin lymphoma (NHL) cases.³ NHL is one of the most common forms of cancer in the US, accounting for about 4% of all cancer cases,⁵ and causing more than 80,000 deaths each year.⁵ 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.

"Accurately differentiating lymphoma from an infection is critical in ensuring accurate and timely diagnosis, especially as the symptoms can appear similar," said Jill German, Head of Pathology Lab at Roche Diagnostics. "With this new test, clinicians can have confidence in their diagnosis, while the test reduces the need for multiple samples and time consuming follow up tests, giving patients certainty sooner, and enabling faster access to the right treatment."

With increased sensitivity, the new VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail 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 facilitate a faster diagnosis and access to treatment for patients.

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

About the VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail 
The VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail Assay is a qualitative assay that is used to detect the expression of kappa and lambda immunoglobulin light chains in formalin-fixed paraffin embedded (FFPE) human hematolymphoid specimens by in situ hybridization (ISH).

The assay is intended as an aid in the diagnosis of mature B-cell lymphomas and plasma cell neoplasms. The VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail is indicated for use when a biopsy of lymph node or bone marrow (core biopsy and clot section) indicates inconclusive results. It enables the assessment of both markers in the context of one another on a single slide as an aid in differentiating between a reactive process or B-cell lymphoma and plasma cell neoplasms.

This is not a standalone test, and results should be evaluated by a qualified pathologist within the context of the patient's clinical history and other diagnostic tests. 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.

For over 125 years, sustainability has been an integral part of Roche's business. As a science-driven company, our greatest contribution to society is developing innovative medicines and diagnostics that help people live healthier lives. Roche is committed to the Science Based Targets initiative and the Sustainable Markets Initiative to achieve net zero by 2045.

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

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

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SOURCE Roche

FAQ

What is the significance of Roche's (RHHBY) new FDA-cleared lymphoma test?

Roche's VENTANA test is the first clinically approved ISH test that can assess all B-cell lymphoma subtypes, helping differentiate cancer from normal immune responses and enabling faster diagnosis and treatment.

How does Roche's (RHHBY) new VENTANA test improve lymphoma diagnosis?

The test can evaluate over 60 B-cell lymphoma subtypes on a single tissue slide, requires smaller samples, and reduces the need for multiple biopsies, making diagnosis faster and more efficient.

When did Roche (RHHBY) receive FDA clearance for the VENTANA lymphoma test?

Roche received FDA 510(k) clearance for the VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail test on January 13, 2025.

What market size does Roche's (RHHBY) new lymphoma test address?

The test addresses B-cell lymphoma, which represents 85% of non-Hodgkin lymphoma cases. NHL accounts for 4% of all US cancer cases and causes over 80,000 deaths annually.

When did Roche (RHHBY) receive CE Mark approval for the VENTANA test?

Roche received CE Mark approval for the VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail test in June 2024.