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Wednesday, July 29, 2020

FDA approves Roche’s new VENTANA HER2 Dual ISH test as companion diagnostic to identify breast cancer patients eligible for targeted therapy

FDA approves Roche’s new VENTANA HER2 Dual ISH test as companion diagnostic to identify breast cancer patients eligible for targeted therapy

  • Nearly 2.1 million new cases of breast cancer are diagnosed worldwide each year, and more than 620,000 people will die from the disease.1 About 15 to 20 percent of women diagnosed with breast cancer are HER2 positive.2
  • VENTANA HER2 Dual ISH DNA Probe Cocktail assay3 aids in identifying HER2-positive breast cancer patients eligible for the targeted Roche drug Herceptin (trastuzumab)
  • Developed with enhanced technology, this new assay provides high-quality staining with improved turnaround time

Basel, 29 July 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced US Food and Drug Administration (FDA) approval of the new 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. HER2 - human epidermal growth factor receptor 2 - is an important biomarker sometimes found in breast cancers.2 Its detection and inhibition can help healthcare professionals more effectively manage this aggressive cancer.

The VENTANA HER2 Dual ISH DNA Probe Cocktail assay is designed to be completed within the same day, enabling clinicians to get results back faster than with other common methods of confirmatory testing for HER2. Results can be read using light microscopy, eliminating the need for a specialised fluorescence microscope.

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

This assay was launched as a CE IVD in April 2019.

The new VENTANA HER2 Dual ISH DNA Probe Cocktail assay is one component of Roche’s comprehensive breast cancer solutions portfolio designed to help inform decision making in cancer care and contribute to improved patient outcomes. For more information about the assay and the portfolio, please visit the Roche Tissue Diagnostics breast cancer IHC/ISH portfolio page or the Anatomic Pathology site.

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