UNITED KINGDOM – AstraZeneca and China-based Amoy Diagnostics (AmoyDx) have signed a master collaboration agreement for multiple companion diagnostics programs in China, the EU, and Japan.

The agreement allows both companies to collaborate on the development and marketing of AmoyDx assays for any indication or biomarker for companion diagnostic (CDx) use with AstraZeneca medications around the world.

Since early 2021, AmoyDx has been collaborating with Big Pharma on the development of a molecular companion diagnostic for precision therapies in ovarian cancer, including a test to assess homologous recombination deficiency, or interruptions in the body’s ability to repair damaged DNA.

Prior to that, the companies obtained Chinese approval for a BRCA1/BRCA2 test to be used in conjunction with AstraZeneca’s Lynparza (olaparib) for the treatment of breast and ovarian cancers.

The two companies will now work together on prostate cancer tests to identify gene mutations that obstruct homologous recombination repair, or HRR, the process that helps drive the body’s DNA damage response.

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

They will create a CDx to identify breast cancer patients in the EU with BRCA gene mutations for Lynparza (olaparib) monotherapy.

Homologous Recombination Repair and BRCA mutations are well-documented targets for PARP inhibitor therapy, as well as key biomarkers to guide potential PARP inhibitor treatment options.

Lynparza, which was developed in collaboration with AstraZeneca and MSD, is approved in a number of countries for the treatment of advanced ovarian, breast, prostate, and pancreatic cancer.

AmoyDx’s collaborations

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.

AmoyDx also has cancer companion diagnostic collaborations with Amgen and the Germany-based Merck, among others.

AmoyDx has been working with Amgen on a test for the KRAS inhibitor Lumakras (sotorasib) in non-small cell lung cancer for sale in Japan, while Merck has enlisted AmoyDx’s assistance with its MET inhibitor Tepmetko (tepotinib) aimed at lung cancer patients in the Chinese market.

Meanwhile, AstraZeneca collaborated with Thermo Fisher Scientific on a global, multiyear agreement for companion diagnostics across its precision medicine pipelines late last year.

More than 90% of AstraZeneca’s clinical drug candidates, including cancer and cardiovascular disease, as well as kidney, metabolic, and respiratory conditions, use a targeted approach, according to the company.

In addition to broader efforts to raise awareness of biomarker screening and the adoption of genomic testing, the two hope to introduce paired diagnostics early in clinical trials, so tests will be ready to launch alongside an FDA green light.

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