Roche (RHHBY) announced that it has received 510(k) clearance from the FDA for its highly-sensitive in-situ hybridisation test, the Ventana Kappa and Lambda Dual ISH mRNA Probe Cocktail. The test is designed to help pathologists differentiate a B-cell malignancy from a normal, reactive response to an infection. This announcement follows the assay’s CE Mark approval in June 2024.
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