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Leica Developing CDx to Screen Patients for Galena Breast Cancer Drug

NEW YORK (GenomeWeb News) – Galena Biopharma and Leica Biosystems today announced a deal for the development of a companion diagnostic for Galena's therapeutic for breast cancer.

Under the partnership, Leica's Bond Oracle HER2 IHC System companion diagnostic will be used to select patients for Galena's NeuVax Phase 3 Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low-to-Intermediate HER2 Expression with NeuVax Treatment, or PRESENT, study.

NeuVax (nelipepimut-S) is the immunodominant nonapeptide derived from the extracellular domain of the HER2 protein, an established target for therapeutic intervention in breast carcinoma, Galena and Leica, a Danaher company, said. It targets HER2-negative patients who are in remission with the current standard of care, but don't have available HER2-targeted adjuvant treatment options to remain disease-free.

Leica's Bond Oracle HER2 IHC System is a semi-quantitative immunohistochemical assay for determining HER2 status in breast cancer tissue processed for histological assessment. The system is cleared by the US Food and Drug Administration.

"By partnering with Leica, we will be able to help pioneer personalized medicine for patients while ensuring the proper and accurate assessment of breast cancer patients considering participation in the NeuVax PRESENT trial," Galena President and CEO Mark Ahn said in a statement.

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