Roche Diagnostics

Pathology Lab

Roche’s momentum in digital pathology continues with FDA clearance on its high-volume slide scanner

The VENTANA DP 600 slide scanner, part of Roche’s Digital Pathology Dx system, is now cleared by the FDA to aid in clinical diagnosis, enabling pathologists to diagnose patients using digital images.

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Pathology Lab

Roche receives FDA clearance for new, highly sensitive test to aid clinicians in diagnosing B-cell lymphoma

The VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail assay is the first clinically approved, in-situ hybridization (ISH) test with the sensitivity to assess the full spectrum of B-cell lymphoma subtypes

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Pathology Lab

Roche receives FDA approval for first companion diagnostic to identify patients with biliary tract cancer

The PATHWAY HER2 (4B5) test helps identify patients with previously treated, unresectable or metastatic HER2-positive biliary tract cancer (BTC) who may be eligible for treatment with ZIIHERA.

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Roche receives FDA approval for the first companion diagnostic to identify patients with gastric and gastroesophageal junction cancer eligible for targeted treatment with VYLOY

Pathology Lab

Roche expands companion diagnostic portfolio with FDA approval of CLDN18 assay

The new VENTANA CLDN18 (43-14A) RxDx Assay helps fulfill an unmet medical need by enabling clinicians to identify patients with gastric or gastroesophageal junction (GEJ) cancer.