The first and only FDA-approved companion diagnostic for assessing HER2-low status since 2022 is now also approved to aid in the assessment of HER2-ultralow status for patients with MBC.
The Roche Diagnostics Tina-quant® Lipoprotein (a) Gen.2 Molarity assay is an in-vitro test measuring lipoprotein (a) in a person’s bloodstream (serum and plasma), and will be broadly available on Roche's chemistry systems in the U.S.
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.
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