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Agena Bioscience MassArray System Cleared by China FDA

NEW YORK (GenomeWeb) — Agena Bioscience and DaRui Biotechnology announced today that Agena's MassArray system has been cleared by the China Food and Drug Administration.

The system is a mass spectrometry-based platform that Agena acquired from Sequenom in 2014 for measuring genetic variants. In 2016, Agena partnered with Guangzhou-based DaRui to develop MassArray-based in vitro diagnostics for cancer and inherited diseases for China, where it is marketed as DR MassArray.

"We are thrilled with this achievement and look forward with our partnership to introducing a new era of multi-gene, high-throughput, and low-cost routine diagnostic testing in Chinese hospitals and independent laboratories," Agena CEO Peter Dansky said in a statement.

Agena has been working to build a presence in China for a number of years. Since establishing a subsidiary in Shanghai in 2015, the San Diego-based firm has inked a number of China-focused partnerships including ones with CapitalBio Technology to commercialize genetic agricultural tests, with Simcere Diagnostics to develop companion diagnostics and pharmacogenomic tests, and with Zhejian Dian Diagnostics to commercialize the MassArray system and DNA testing applications and products.