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.

Cancer continues to be a significant societal challenge as the 2nd leading cause of death in the United States and worldwide.1 In the US, approximately 1.9 million new cancer cases were expected to be diagnosed in 2022.1 Of these cases, the vast majority will consist of solid tumors, approximately 14% of which will have been shown to have defects in any of the MMR proteins.

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.

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.