July 30, 2020—Roche announced U.S. Food and Drug Administration approval of 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 assay is designed to be completed the same day, and results can be read using light microscopy.
“With this new Ventana HER2 Dual ISH assay, Roche continues to deliver on its commitment to advance personalized health care,” Thomas Schinecker, CEO of Roche Diagnostics, said in a press release. “Quick results are crucial in the fight against cancer and by delivering critical information on treatment options for breast cancer patients faster, this assay will aid clinicians in their therapeutic decisions.”
The assay was launched as a CE IVD in April 2019 and is for use with the Ventana Silver ISH DNP Detection Kit and the Ventana Red ISH DIG Detection Kit on the fully-automated BenchMark Ultra.