Roche Gets FDA Clearance For New Diagnostic Test For B-Cell Lymphoma

Roche announced that it has received 510(k) clearance from the Food and Drug Administration for its highly sensitive in-situ hybridization 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% of non-Hodgkin lymphoma cases. NHL is one of the most common forms of cancer in the U.S., 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 industry-leading hematopathology portfolio, which includes more than 65 biomarkers.