Roche receives FDA approval for assay to detect the HER2 biomarker in breast cancer
Roche received approval from the U.S. Food and Drug Administration (FDA) for the 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, the company said in a press release.
Human epidermal growth factor receptor 2 (HER2) is a biomarker found in some breast cancers.
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, according to Roche. Results can be read using light microscopy, eliminating the need for a specialized fluorescence microscope.
The assay was launched as a CE IVD in April 2019.
The new VENTANA HER2 Dual ISH DNA Probe Cocktail assay is optimized for use with the VENTANA Silver ISH DNP Detection Kit and the VENTANA Red ISH DIG Detection Kit on the automated BenchMark ULTRA. Roche pointed out it is an enhanced version of the previous-generation test.
