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FDA approves VENTANA HER2 Dual ISH DNA Probe Cocktail assay for detection HER2+ breast cancer.- Roche
Roche announced FDA approval of the new VENTANA HER2 Dual ISH DNA Probe Cocktail assay for the detection of the HER2 biomarker in breast cancer and as a companion diagnostic for Herceptin (trastuzumab) therapy. HER2 - human epidermal growth factor receptor 2 - is an important biomarker sometimes found in breast cancers. Its detection and inhibition can help healthcare professionals more effectively manage this aggressive cancer. The VENTANA HER2 Dual ISH DNA Probe Cocktail 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. Results can be read using light microscopy, eliminating the need for a specialised fluorescence microscope. This assay was launched as a CE IVD in April 2019.
Condition: Breast Cancer HER2+
Type: drug