AstraZeneca Taps China’s AmoyDx for Companion Diagnostics

In March, AstraZeneca’s Lynparza (olaparib), a PARP inhibitor the company co-developed with Merck (known as MSD outside the US and Canada), received approval in the US as adjuvant treatment for patients with BRCA-mutated HER2-negative high-risk early breast cancer. 

With any use of medical drugs such as Lynparza, companion diagnostics (CDx) are required to monitor the treatment process. For that purpose, AstraZeneca has reached out to Amoy Diagnostics (AmoyDx), a China-based molecular diagnostics company to develop assays for indications and biomarkers targeted by AstraZeneca medicines. 

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Projects under the Agreement

AstraZeneca and AmoyDx are expected to begin work co-developing a CDx that identifies prostate cancer patients with Homologous Recombination Repair (HRR) gene mutations in China, the EU, and Japan. 

The two companies will also prioritize a CDx to identify breast cancer patients with BRCA gene mutations in the EU for Lynparza monotherapy. 

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

“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.”

AmoyDx already has an ongoing collab with AstraZeneca over the development of a Homologous Recombination Deficiency (HRD) CDx in ovarian cancer. 

Even earlier, AmoyDx’s BRCA1/BRCA2 kit was approved as CDx for Lynparza about two years ago. 

AmoyDx’s Other Collaborations

Earlier this month, AmoyDx inked a deal with Chinese biopharma Hutchmed to develop molecular diagnostics in Osimertinib/Savolitinib combo treatment for non-small cell lung cancer (NSCLC) in the Chinese market. 

The company also collaborated with Amgen in 2020 to develop tests for Sotorasib, then known as AMG 510 in Amgen’s oncology portfolio that inhibits the KRAS G12C mutation in NSCLC. Sotorasib was granted FDA approval in May last year. 

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Joy Lin

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