FDA Approves Breast Cancer Companion Diagnostic for Trastuzumab Therapy
Posted: Monday, August 3, 2020
On July 29, the U.S. Food and Drug Administration (FDA) approved a companion diagnostic test, the VENTANA HER2 Dual ISH DNA Probe Cocktail assay, for the identification of patients with HER2-positive breast cancer who may be eligible for trastuzumab treatment.
The companion diagnostic was initially launched as a CE in vitro diagnostic test in April 2019, and the updated version includes new oligonucleotide probes and sensitive detection kits. In addition, the new 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.
According to the manufacturer, features of the companion diagnostic test include its rapid turnaround time and same-day results compared with traditional confirmatory testing for the HER2 gene. In addition, results can be read using light microscopy, eliminating the need for clinicians to use a specialized fluorescence microscope.
