FDA CLIA-waived tests broaden access to accurate, easy-to-use diagnostics for all patients in decentralized settings like urgent care centers, retail clinics, and community health venues.
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.
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
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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