Roche’s HER2 Companion Diagnostic for Breast Cancer: FDA approval

Roche’s HER2 Companion Diagnostic for Breast Cancer: FDA approval


  • Post By : Kumar Jeetendra

  • Source: Roche

  • Date: 30 Jul,2020

Roche, Basel, Switzerland, has received FDA approval for its Ventana HER2 Dual ISH DNA Probe Cocktail assay for the detection of the human epidermal growth factor receptor 2 (HER2) biomarker in breast cancer and as a companion diagnostic for Herceptin (trastuzumab) therapy. HER2 is an important biomarker sometimes found in breast cancer, and its detection and inhibition can help healthcare professionals more effectively manage this aggressive cancer.

3D rendering of HER2. Amplification of this oncogene has been shown to play an important role in the development and progression of certain aggressive types of breast cancer. Image © ibreakstock, courtesy (ID 84896320).

The Ventana HER2 Double ISH DNA Probe Cocktail assay is intended to be completed within precisely the exact same day, enabling clinicians to get results back quicker than with other common procedures of confirmatory testing for HER2. Results can be read using light microscopy, eliminating the need for a specialized fluorescence microscope.

“With this new VENTANA HER2 Dual ISH assay, Roche continues to deliver on its commitment to advance personalised healthcare,” says Thomas Schinecker, CEO of Roche Diagnostics. “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.”

For more information, visit Roche.

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