Roche: new Ventana device approved in US

(CercleFinance.com) - On Monday Roche announced that it has received clearance from the US FDA to market a new Ventana diagnostic tool for differentiating malignant B-cell tumors from other tumors.


The Swiss biopharmaceutical group states that the 510(K) clearance of this chromogenic in situ hybridization (ISH) test will enable physicians to identify the best treatment for their patients.

The device - dubbed the 'Ventana Kappa and Lambda Dual ISH mRNA Probe Cocktail' - is capable of distinguishing between some sixty subtypes of B lymphoma and plasma cell neoplasms from a single sample slide.

This system had already received CE marking in June 2024.

According to Roche, B-cell lymphomas account for around 85% of non-Hodgkin's lymphomas in the US, the latter being one of the most frequently encountered forms of cancer in the country, with 5% of cancer cases diagnosed each year and over 80,000 deaths per year.


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