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New VENTANA HER2 ISH DNA Assay Launches for Breast, Gastric Cancers

Gina Columbus @ginacolumbusonc
Published: Tuesday, Apr 23, 2019

Michael Heuer

Michael Heuer

A new VENTANA HER2 dual in situ hybridization (ISH) companion diagnostic assay has launched to identify HER2 amplification for patients with breast cancer and gastric cancer who could be eligible to receive trastuzumab (Herceptin), according to Roche, the manufacturer of the test.

The approval was based on data from the HannaH (NCT00950300) and SafeHER (NCT01566721) studies, in which Herceptin Hylecta demonstrated comparable rates of efficacy and safety compared with the standard IV use of trastuzumab, as well as the PrefHER trial (NCT01401166), which suggested a patient preference for the subcutaneous regimen.
Roche Launches New VENTANA HER2 Dual ISH Companion Diagnostic Test For Breast and Gastric Cancer Patients Eligible for Targeted Therapy. Roche. Published April 23, 2019. Accessed April 23, 2019.

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