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AmoyDx, AstraZeneca Partner on HER2 Lung Cancer CDx Development in China

NEW YORK – Amoy Diagnostics said Tuesday that it has forged a partnership with AstraZeneca to develop its AmoyDx Essential NGS panel as a companion diagnostic for use in China with the drug firm's Enhertu (trastuzumab deruxtecan) antibody-drug conjugate for treatment of non-small cell lung cancer.

Enhertu was jointly developed and commercialized by AstraZeneca and Daiichi Sankyo, and China-based Amoy said the therapy is approved in China to treat patients who have received previous treatments for HER2-low and HER2-positive metastatic breast cancer. In August 2022, the US Food and Drug Administration also approved the therapy for use with previously treated advanced NSCLC patients whose tumors have active HER2 mutations.

Amoy Founder and Chairman Li-Mou Zheng said in a statement, "Through this collaboration, we hope to further our understanding of HER2 mutations and support the development of Enhertu for lung cancer patients in China." The firm noted that the agreement announced Tuesday builds on ongoing collaborations to develop and commercialize AmoyDx assays for companion diagnostic use with AstraZeneca's prostate, breast, and ovarian cancer therapies.

In July, the firms also signed a collaboration agreement to advance its AmoyDx HRD Complete Panel as a companion diagnostic for AstraZeneca's Lynparza (olaparib) PARP inhibitor. The therapy is approved in China for maintenance treatments of patients with HRD-positive advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer.

Guardant Health and Thermo Fisher Scientific also announced one year ago that they had gained FDA premarket approvals for their next-generation sequencing assays as companion diagnostics for use with Enhertu in NSCLC patients.