In Vitro Diagnostic Test for B-Cell Lymphomas, Plasma Cell Neoplasms Receives FDA Clearance

The FDA has granted 510(k) clearance to a new, high-sensitivity in situ hybridization (ISH) test to help diagnose B-cell lymphomas and plasma cell neoplasms. Roche, the company developing the test as the Ventana Kappa and Lambda Dual ISH mRNA Probe Cocktail assay, announced the clearance in a press release.

The single-slide, in vitro diagnostic assay uses ISH to detect expression of kappa and lambda immunoglobulin light chains in formalin-fixed, paraffin-embedded human hematolymphoid specimens. It helps clinicians distinguish more than 60 subtypes of mature B-cell lymphomas and plasma cell neoplasms from normal immune system responses in patients.

“Accurately differentiating lymphoma from an infection is critical in ensuring accurate and timely diagnosis, especially as the symptoms can appear similar,” remarked Jill German, head of the pathology lab at Roche Diagnostics.

The assay already received CE Mark approval in June 2024 and it is the first test of its kind to receive approval from the FDA.

“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,” German elaborated.

Use of the Ventana Kappa and Lambda Dual ISH mRNA Probe Cocktail assay is currently indicated for when diagnostic results from lymph node or bone marrow biopsies are inconclusive. Clinicians are not to base their diagnosis solely on the assay’s findings but consider the findings alongside patient history and results from other tests.

Reference

Roche receives FDA clearance for new, highly-sensitive test to aid clinicians in diagnosing B-cell lymphoma. Press release. PR Newswire. January 13, 2025. Accessed January 29, 2025.