China-based Amoy Diagnostics (AmoyDx) has signed a master collaboration agreement with AstraZeneca for multiple companion diagnostics programmes in China, the EU and Japan.

The agreement will enable both firms to work together on the development and marketing of AmoyDx assays for any type of indication or biomarker for companion diagnostic (CDx) usage with AstraZeneca medications around the world.

Under the agreement, the first project includes the development of CDx to identify prostate cancer patients with Homologous Recombination Repair (HRR) gene mutations in China, the European Union (EU) and Japan.

They will develop 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 therapy, as well as key biomarkers to guide potential treatment choices that include a PARP inhibitor.

Lynparza was developed in collaboration with AstraZeneca and MSD which is authorised in several countries for the treatment of advanced ovarian, breast, prostate, and pancreatic cancers.

The AmoyDx decentralised CDx is based on the HANDLE system, a patented NGS library building technique created by AmoyDx that can perform HRR or BRCA gene mutation testing in three days.

AmoyDx founder and chairman Li-Mou Zheng said: “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 Commercialisation 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.”

AmoyDx provides a range of molecular tests and serves as the therapeutic diagnostics partner for many large international pharmaceutical firms that offer precision cancer medicines.