Shanghai-based Agena Bioscience announced that its human CYP2C19 genotyping test kit, co-developed with Simcere Pharmaceutical Group’s subsidiary Simcere Diagnostics, has been approved by the National Medical Products Administration (NMPA) as a Category III product. The kit is designed for the qualitative detection of CYP2C19 gene polymorphism in peripheral blood samples of patients with coronary heart disease and ischemic stroke who are taking or will take clopidogrel as an antiplatelet therapy in vitro.
Significance of the Approval
This marks the second Category III approval based on the MassARRAY nucleic acid mass spectrometry platform globally, following Darui Bio’s deafness gene detection kit in January this year. The approval highlights the growing recognition of MassARRAY technology in clinical diagnostics.
Technology and Partnership
Agena Bioscience, known for its MassARRAY nucleic acid mass spectrometry technology, partnered with Simcere Dx in 2018 to advance the application of nucleic acid mass spectrometry technology in the clinical field, with a focus on pharmacogenomics. This collaboration has been instrumental in developing innovative diagnostic solutions for personalized medicine.-Fineline Info & Tech
