Roche’s new assay is designed to identify the HER2 biomarker in breast and gastric cancers. Credit: F. Hoffmann-La Roche Ltd.

Roche has launched the Ventana HER2 Dual ISH DNA Probe Cocktail, a companion diagnostic to detect which breast and gastric cancer patients are eligible for targeted therapy.

The assay is designed to identify the human epidermal growth factor receptor 2 (HER2) biomarker in breast and gastric cancers. It delivers test results on the same day, quicker than the standard HER2 confirmatory approaches.

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Results from the new test can be read using light microscopy, which avoids the requirement for a specialised fluorescence microscope. The assay can be fully automated on the BenchMark IHC/ISH instruments.

Roche Diagnostics CEO Michael Heuer said: “The new Ventana HER2 Dual ISH assay advances Roche’s commitment to personalised healthcare by delivering critical information on treatment options for breast and gastric cancer patients faster.

“Quick results are crucial in the fight against cancer, and every additional day that a clinician and a patient must wait for test results is a day too long.”

“Quick results are crucial in the fight against cancer, and every additional day that a clinician and a patient must wait for test results is a day too long.”

Ventana HER2 Dual ISH DNA Probe Cocktail assay is intended to identify patients for targeted therapy with the company’s Herceptin (trastuzumab) medicine.

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Herceptin is a humanised monoclonal antibody that blocks the function of the HER2 receptor by inhibiting the signals that the HER2 protein sends to promote tumour cell growth. The drug also stimulates the body’s immune system to fight the cancer cells.

According to Roche, Herceptin has been used for treating more than two million HER2-positive breast and gastric cancers patients since its first approval in 1998.

The company’s portfolio of diagnostic and predictive assays also includes the Ventana HER2/neu (4B5) Rabbit Monoclonal Primary Antibody to assess breast cancer patients considered for Herceptin treatment.

Currently, Roche is introducing the Ventana HER2 Dual ISH assay in Europe, the Middle East, Africa, Latin America and Asia Pacific. The company also plans to seek approval from the US Food and Drug Administration (FDA).