Roche gets USFDA clearance for highly-sensitive test to aid clinicians in diagnosing B-cell lymphoma

Basel: Roche has announced 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.

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. 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. NHL is one of the most common forms of cancer in the US, accounting for about 4% of all cancer cases, and causing more than 80,000 deaths each year. 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 hematopathology portfolio, which includes more than 65 biomarkers.

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.

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