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AmoyDx, AstraZeneca Collaborate to Develop, Commercialize Companion Diagnostic Tests

NEW YORK ─ Chinese diagnostics firm Amoy Diagnostics on Monday announced that it has entered into a collaboration agreement with AstraZeneca to develop and commercialize AmoyDx assays that may cover any type of indication or biomarker for companion diagnostic use with AstraZeneca medicines.

Financial and other terms of the agreement were not disclosed.

The first projects to be initiated under the agreement include the codevelopment of a CDx to identify prostate cancer patients in China, the European Union, and Japan with homologous recombination repair (HRR) gene mutations, and a CDx to identify breast cancer patients in the EU with BRCA gene mutations for AstraZeneca/Merck's Lynparza (olaparib) monotherapy. 

Lynparza, a PARP inhibitor, is approved in a number of countries for the treatment of advanced ovarian, breast, prostate, and pancreatic cancers.

AmoyDx said its decentralized CDx are based on an NGS library construction technology that can enable the completion of testing for HRR or BRCA gene mutations within three days.

In February, the company announced it had entered into a collaboration agreement with French pharmaceutical firm Pierre Fabre to develop companion diagnostic kits in China.