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AmoyDx Enters into Master Collaboration Agreement with AstraZeneca for Multiple Companion Diagnostics Programs in China, EU and Japan

April 18, 2022 Shanghai, China——Amoy Diagnostics Co., Ltd (AmoyDx), a China based innovative molecular diagnostics company (SZSE: 300685), today announces that it has entered into a Master Collaboration Agreement (Agreement) with AstraZeneca (LSE/STO/Nasdaq: AZN), a global, science-led biopharmaceutical company. The master collaboration agreement enables the Parties to collaborate in the development and commercialization of AmoyDx assays that may cover any type of indication or biomarker for companion diagnostic (CDx) use with AstraZeneca medicines globally.

The first projects to be initiated under the Agreement include the co-development of a CDx to identify prostate cancer patients with Homologous Recombination Repair (HRR) gene mutations in China, the EU and Japan, and a CDx to identify breast cancer patients with BRCA gene mutations in the EU for Lynparza® (olaparib) monotherapy.  HRR and BRCA mutations are well-documented targets for PARP inhibitor treatment and are important biomarkers that can inform potential treatment options including  a PARP inhibitor.  Lynparza® (olaparib) is a first-in-class PARP inhibitor jointly developed by AstraZeneca and MSD and approved in a number of countries for the treatment of advanced ovarian, breast, prostate and pancreatic cancers. The AmoyDx decentralized CDx are based on the HANDLE® system, a proprietary NGS library construction technology developed by AmoyDx, can enable the testing of HRR or BRCA gene mutations to be completed within three days.

Li-Mou Zheng, Ph.D., Founder and Chairman of AmoyDx, commented: “We are very pleased to announce today that we are further developing our partnership with AstraZeneca by entering into a master collaboration agreement. AmoyDx is a trustworthy CDx co-development partner with rich expertise in R&D, Regulatory Affairs and Commercialization globally. AmoyDx and AstraZeneca share the common core value of prioritizing patients, and we will work together to accelerate the contribution for the benefit of patients.”

About Amoy Diagnostics Co., Ltd.
Amoy Diagnostics Co., Ltd. (SZSE: 300685) is a leading biotech company which pioneered the development and commercialization of cancer diagnostics in China. It is the largest provider of molecular diagnostics products for personalized healthcare in China, as well as a service center for oncology biomarker analysis. AmoyDx has a market-leading portfolio of molecular tests and is the therapy diagnostics partner for several major multinational pharmaceutical companies offering precision therapies for cancer.

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