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FDA Approves Roche Breast Cancer Companion Diagnostic for Herceptin

NEW YORK – Roche announced Wednesday its Ventana HER2 Dual ISH DNA Probe Cocktail test received approval from the US Food and Drug Administration as a companion diagnostic for trastuzumab (Roche's Herceptin).

The test detects the human epidermal growth factor receptor 2 (HER2) biomarker in breast cancer and is meant to be completed within the same day, allowing for faster results than other HER2 testing methods. Results can also be read using light microscopy so there isn't a need for a specialized fluorescence microscope, Roche said in a statement. 

The new test can be used with the Ventana Silver ISH DNP Detection Kit and the Ventana Red ISH DIG Detection Kit on the BenchMark Ultra. It's an enhanced version of Roche's previous test with new oligonucleotide probes.

Roche's test received CE-IVD marking in 2019.

"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," Roche Diagnostics CEO Thomas Schinecker said in a statement.