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

Developed with enhanced technology, this new assay provides high-quality staining with improved turnaround time

30 Jul 2020


Roche has 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. 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. 

About the VENTANA HER2 Dual ISH DNA Probe Cocktail assay
Roche is the only provider of an FDA approved ready-to-use brightfield Dual ISH solution for the detection of HER2 amplification. The new VENTANA HER2 Dual ISH DNA Probe Cocktail assay is optimised for use with the VENTANA Silver ISH DNP Detection Kit and the VENTANA Red ISH DIG Detection Kit on the fully-automated BenchMark ULTRA.
The VENTANA HER2 Dual ISH DNA Probe Cocktail assay is an enhanced version of the previous-generation test. New oligonucleotide probes and highly sensitive detection kits provide clear results to pathology labs more quickly, allowing clinicians to make treatment decisions earlier.

As a global leader in breast cancer diagnostics, Roche provides a comprehensive menu of both diagnostic and predictive assays, including the PATHWAY HER2/neu (4B5) Rabbit Monoclonal Primary Antibody that is indicated as an aid in the assessment of breast cancer patients for whom Herceptin treatment is considered.

About Herceptin (trastuzumab)
Herceptin® is a humanised monoclonal antibody designed to target and block the function of the HER2 receptor, a protein found on the outside of many normal cells and in high quantities on the outside of cancer cells in HER2-positive cancers. Herceptin binds to a specific section of the HER2 protein, inhibiting the signals it sends that encourage tumour cell growth, while also calling on the body’s immune system to attack the cancer cells.

Since it was first approved in 1998, Herceptin has been used to treat over two million patients worldwide, diagnosed with HER2-positive breast and gastric cancers. It has also become the backbone of other innovative treatments for HER2-positive breast cancer, which have continued to improve the outcomes of patients with this otherwise aggressive disease. In addition to the standard intravenous formulation, Herceptin is available in a subcutaneous (SC) formulation which was first approved in 2013. Herceptin SC represents a significant step forward in the treatment of HER2-positive breast cancer as it offers patients a faster, more convenient and less painful way to receive treatment with Herceptin.

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