09/06/2022
FlashDx: Point-of-Care (POC) Multiplex Molecular Diagnostic System FDx-1000 Obtained NMPA Class III Medical Device Registration Certificate
FDx-1000, the proprietary product developed by FlashDx has recently secured China National Medical Products Administration (NMPA, aka China FDA) approval with Class III medical device registration certificate. The corresponding version of FlashDx-1000-E for overseas launch has also obtained EU CE-IVDR certification.
FDx-1000 is a fully automated POC (Point-of-Care) multiplex nucleic acid detection equipment that integrates nucleic acid extraction, amplification, and detection with "sample-in and result-out". Using fully enclosed cartridges with pre-loaded reagents, users only need to add samples with about 1 minute hand-on time. The multiplex real-time quantitative nucleic acid detection can be completed in as little as 40 minutes anytime, anywhere.
Powered by proprietary Microarray-qPCR technologies developed by FlashDx, FDx-1000 provides the sensitivity and specificity comparable to traditional TaqMan qPCR technology and performs highly multiplex nucleic acid detection with single channel fluorescence in a one-pot reaction. It truly offers end users simple, affordable solutions for instant multiplex molecular diagnostics.
Founded by seasoned industry experts across the globe, FlashDx provides turn-key Point-of-Care Molecular test solutions that can be widely applied to hospitals, clinics and physician’s offices. Since its establishment in 2018, the company has developed its IP portfolio and built a 2,500-square-meter R&D laboratory and GMP production plant. The company has also received several rounds of financing from well-known institutions such as Fosun Capital, Zhejiang United Investment Group ("ZUIG"), Yuanbio Venture Capital, and etc. FlashDx’s proprietary Microarray-qPCR technology, combined with the low-cost microfluidic design, enables a highly-multiplex (20-plex or more) quantitative nucleic acid detection from sample to answer in as little as 40 minutes.
Keen on its vision of providing “Affordable Accurate Access” of molecular diagnostics to everyone, FlashDx is dedicated to applying the platform with a growing test menu with its initial focus on syndromic testing in the infectious disease area. The portfolio will expand to oncology and other applications such animal health, identification testing, environment monitoring and food/drug safety etc. FlashDx is OPEN to collaborations at all levels to develop various applications based on its platform.