Amoy Diagnostics, a China based innovative molecular diagnostics company, has entered into a Master Collaboration Agreement with AstraZeneca. The 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.