The companies will develop a CDx to identify prostate cancer patients with HRR gene mutations in China, Japan, and the EU. Credit: Nephron/ commons.wikimedia.org.

Amoy Diagnostics (AmoyDx) and AstraZeneca have signed a master collaboration agreement for multiple companion diagnostics programmes in China, Japan, and the European Union (EU).

Through the collaboration, the companies will co-develop and commercialise AmoyDx assays that may cover any indication or biomarker type for companion diagnostic (CDx) use with AstraZeneca medicines across the world.

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Under the deal, the initial projects to be commenced include a CDx co-development for identifying prostate cancer patients in China, Japan, and the EU, with homologous recombination repair (HRR) gene mutations.

It also includes a CDx development which will be used for detecting breast cancer patients, in the EU, with BRCA gene mutations for Lynparza (olaparib) monotherapy. 

Jointly developed by AstraZeneca and MSD, Lynparza is a PARP inhibitor that is approved to treat advanced ovarian, breast, prostate, and pancreatic cancers in many countries.

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AmoyDx stated that its decentralised CDx are based on the company’s NGS library construction technology, HANDLE system, that can enable the completion of HRR or BRCA gene mutations testing within three days.

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It also noted that these mutations are well-documented targets for PARP inhibitor treatment, and are claimed to be the key biomarkers that can help in informing potential treatment options, including a PARP inhibitor.

AmoyDx founder and chairman Li-Mou Zheng said: “We are very pleased to announce that we are further developing our partnership with AstraZeneca, by entering into a master collaboration agreement.

“AmoyDx and AstraZeneca share the common core value of prioritising patients, and we will work together to accelerate the contribution for the benefit of patients.”

In August last year, the Japanese Ministry of Health, Labour, and Welfare (MHLW) approved the company’s AmoyDx Pan Lung Cancer PCR Panel as a CDx for Tepmetko (tepotinib).