Roche Secures US FDA Approval for its Ultra-Sensitive ISH test

Roche announced that it has obtained 510(k) approval from the United States Food and Drug Administration (FDA) for its ultra-sensitive in-situ hybridisation (ISH) assay, the VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail. The assessment aims to assist pathologists in distinguishing a B-cell cancer from a regular, reactive response to an infection, thereby enabling quicker access to treatment. This announcement comes after the assay received its CE Mark approval in June 2024.

B-cell lymphoma is a kind of cancer that usually emerges within the lymphatic system. It makes up roughly 85 percent of non-Hodgkin lymphoma (NHL) instances. NHL is among the most prevalent cancer types in the US, representing roughly 4% of total cancer cases and leading to over 80,000 fatalities annually. In the initial phases of NHL, individuals might encounter symptoms such as swollen lymph nodes, fever, fatigue, decreased 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.”