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# FDA Approves Roche Ventana Diagnostic Test
- URL: https://www.fdaweb.com/fda-approves-roche-ventana-diagnostic-test/
- Published: 2020-07-30T12:00:00.000Z
- Updated: 2026-09-14T16:23:11.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5147323

FDA has approved the Roche Ventana HER2 Dual ISH DNA Probe Cocktail assay to detect the HER2 biomarker in breast cancer and as a companion diagnostic for the company’s Herceptin (trastuzumab). The company [says](https://www.roche.com/media/releases/med-cor-2020-07-29c.htm?ref=fdaweb.com) the assay is designed to be completed within the same day, enabling clinicians to get results back faster than with other common methods of confirmatory testing for HER2.