NEW YORK — Roche said Monday that it has received clearance from the US Food and Drug Administration for an in situ hybridization test to assess the full spectrum of B-cell lymphoma subtypes.
The Ventana Kappa and Lambda Dual ISH mRNA Probe Cocktail assay is designed to differentiate a B-cell malignancy from a normal, reactive response to an infection, Roche said. The test — which was CE marked in mid-2024 — can be used with small biopsies and formalin-fixed paraffin-embedded tissue and can assess more than 60 B-cell lymphoma subtypes and plasma cell neoplasms on a single tissue slide, the Swiss drugmaker added.
"Accurately differentiating lymphoma from an infection is critical in ensuring accurate and timely diagnosis, especially as the symptoms can appear similar," Jill German, pathology lab head at Roche Diagnostics, said in a statement. "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."