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Companion diagnostics

Companion diagnostics

The global partner of choice for companion diagnostics, we help to advance Personalized Healthcare by delivering diagnostic confidence through a broad menu of high medical value predictive assays.

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Global CDx Partner Information

VENTANA PD-L1 (SP263) Assay

VENTANA PD-L1 (SP263) Assay

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.

VENTANA ALK (D5F3) CDx Assay

VENTANA ALK (D5F3) CDx Assay

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

VENTANA PD-L1 (SP142) Assay

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.

Ventana HER2 Dual ISH DNA Probe Cocktail Assay

Ventana HER2 Dual ISH DNA Probe Cocktail Assay

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

VENTANA FOLR1 RxDx IHC

VENTANA FOLR1 RxDx IHC

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).

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Roche receives FDA approval of label expansion for VENTANA PD- L1 (SP263) Assay to identify patients with locally advanced and metastatic non-small cell lung cancer eligible for Libtayo

Roche receives FDA approval of label expansion for VENTANA PD- L1 (SP263) Assay to identify patients with locally advanced and metastatic non-small cell lung cancer eligible for Libtayo

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 expands collaboration with Janssen to advance personalised healthcare through companion diagnostics

Roche expands collaboration with Janssen to advance personalised healthcare through companion diagnostics

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

Roche receives FDA approval for VENTANA FOLR1 (FOLR1-2.1) RxDx Assay as the first IHC-based companion diagnostic to identify ovarian cancer patients eligible for ELAHERE

Roche receives FDA approval for VENTANA FOLR1 (FOLR1-2.1) RxDx Assay as the first IHC-based companion diagnostic to identify ovarian cancer patients eligible for ELAHERE

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).

Roche launches PRAME (EPR20330) Antibody to identify PRAME protein expression in patients that may have melanoma

Roche launches PRAME (EPR20330) Antibody to identify PRAME protein expression in patients that may have melanoma

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

Roche receives FDA approval for first companion diagnostic to identify patients with HER2 low metastatic breast cancer eligible for Enhertu

Roche receives FDA approval for first companion diagnostic to identify patients with HER2 low metastatic breast cancer eligible for Enhertu

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.

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Global CDx Partner Information

The global CDx partner of choice

Roche is the world’s #1 provider of companion diagnostics, offering 20 years’ experience in developing predictive tests that enable personalized cancer treatment for patients.

With unmatched commercial reach, we partner with leading pharmaceutical companies to deliver innovative drugs to more patients, more quickly.

https://www.rochecdx.com

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