Companion diagnostics

VENTANA PD-L1 (SP263) Assay is intended for the qualitative detection of the programmed death ligand 1 (PD-L1) protein in formalin-fixed, paraffin-embedded (FFPE) non-small cell lung cancer (NSCLC), urothelial carcinoma (UC) and other tumor tissues stained with OptiView DAB IHC Detection Kit on a BenchMark IHC/ISH instrument.

The VENTANA ALK (D5F3) CDx Assay empowers your lab to provide timely results with a four-and-one-half hour run time using fully automated, ready-to-use reagents.

VENTANA PD-L1 (SP142) Assay is intended for the qualitative immunohistochemical assessment of the programmed death ligand 1 (PD-L1) protein in formalin-fixed, paraffin-embedded (FFPE) urothelial carcinoma tissue stained with a VENTANA BenchMark ULTRA instrument. PD-L1 status is determined by the proportion of tumor area occupied by PD-L1 expressing tumor-infiltrating immune cells (% IC) of any intensity.

The VENTANA HER2 Dual ISH DNA Probe Cocktail assay is a fully automated, ready-to-use brightfield solution for determining HER2 gene status.

PATHWAY HER2/neu (4B5) Rabbit Monoclonal Primary Antibody is a pre-diluted reagent for use on the Roche BenchMark IHC/ISH automated slide staining instruments.

VENTANA FOLR1 (FOLR1-2.1) RxDx Assay, the first FDA-approved immunohistochemistry companion diagnostic test that helps you detect the Folate Receptor (FOLR1) biomarker in patients with epithelial ovarian cancer (EOC).

The VENTANA PD-L1 (SP263) Assay helps determine which patients with non-small cell lung cancer (NSCLC) may be eligible for treatment with Libtayo monotherapy1 based on the results of the Phase III EMPOWER-Lung 1 study.

New agreement expands activities to include a wide-range of companion diagnostics, including tissue and blood-based biomarkers, sequencing and digital pathology.

Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced US Food and Drug Administration (FDA) approval of the VENTANA FOLR1 (FOLR1-2.1) RxDx Assay, the first immunohistochemistry (IHC) companion diagnostic test to aid in identifying epithelial ovarian cancer (EOC) patients who are eligible for targeted treatment with ELAHERE™ (mirvetuximab soravtansine-gynx).

The PRAME (EPR20330) Antibody evaluates PRAME protein expression from patients with suspected melanoma.

Today the US Food and Drug Administration (FDA) approved the PATHWAY anti-HER2 (4B5) test to identify metastatic breast cancer patients with low HER2 expression for whom Enhertu® (fam-trastuzumab deruxtecan-nxki) may be considered as a targeted treatment.