Roche Receives the US FDA’s Approval for VENTANA HER2 Dual ISH Test as CDx to Identify Breast Cancer
Roche’s cobas SARS-CoV-2 Test Receives the US FDA’s Emergency Use Authorization to Identify Corona Virus
Shots:
- The US FDA has approved the new VENTANA HER2 Dual ISH DNA Probe Cocktail assay to detect HER2 biomarker in BC and as a CDx for Herceptin (trastuzumab) therapy. The assay was launched as a CE IVD in Apr’2019
- 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
- The assay is optimized for use with the VENTANA Silver ISH DNP detection kit and the VENTANA Red ISH DIG detection kit on the fully automated BenchMark ULTRA and is the enhanced version of the previous-generation test
Click here to read full press release/ article | Ref: Roche | Image: StraitTimes