The US Food and Drug Administration (FDA) has granted clearance to the Ventana Kappa and Lambda Dual ISH mRNA Probe Cocktail, an in-situ hybridisation (ISH) test sensitive enough to cover the full spectrum of B-cell lymphoma subtypes.

The FDA clearance follows the assay’s CE Mark approval in June 2024.

The test helps in distinguishing a B-cell cancer from a normal, reactive immune response, providing diagnostic certainty for healthcare providers, according to Roche, the manufacturer of Ventana.

“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,” Jill German, the head of the Pathology Lab at Roche Diagnostics, said in a press release from Roche.

The Ventana Kappa and Lambda Dual ISH mRNA Probe Cocktail can assess small biopsies and formalin-fixed tissue, reducing the need for a fresh tissue sample, which may result in fewer additional patient biopsies and allow for quicker pathology interpretations, according to the company.