FDA Approves New VENTANA HER2 Dual ISH DNA Probe Cocktail Assay for Detection of HER2

July 29, 2020

In addition to being approved to detect the HER2 biomarker in breast cancer, the assay was approved as a companion diagnostic for trastuzumab therapy.

The FDA has approved 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 trastuzumab (Herceptin) therapy, according to Roche, the developer of the assay.

The assay is designed to be completed within the same day, which will enable clinicians to receive patient results faster than with other common methods of confirmatory testing for HER2. Moreover, the results can be read using light microscopy, which eliminates the need for a specialized fluorescence microscope.

“With this new VENTANA HER2 Dual ISH assay, Roche continues to deliver on its commitment to advance personalized healthcare,” Thomas Schinecker, CEO of Roche Diagnostics, said in a press release. “Quick test 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 VENTANA HER2 Dual ISH DNA Probe Cocktail assay was launched as a CE IVD in April 2019. Currently, it 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.

Reference:

FDA approves Roche’s new VENTANA HER2 Dual ISH test as companion diagnostic to identify breast cancer patients eligible for targeted therapy [news release]. Basel. Published July 29, 2020. roche.com/media/releases/med-cor-2020-07-29c.htm. Accessed July 29, 2020.