SugenTech’s Quantitative Immunoassay POCT Platform Approved by Health Canada
SugenTech's quantitative immunoassay point-of-care testing (POCT) platform 'INCLIX F-100' and related reagent (CRP) have received Class II medical device approval from Health Canada.
According to SugenTech on August 7, the approval was obtained under the 'RAMP®' brand of its global diagnostic partner, Response Biomedical (RBM). Headquartered in Vancouver, Canada, RBM is a rapid immunodiagnostics specialist that has been a leader in the field of fluorescence immunoassay for more than 30 years. Leveraging its proprietary RAMP® brand and robust global distribution network, the company has secured a strong presence in the cardiovascular disease diagnosis and rapid quantitative testing markets. With this approval, SugenTech plans to immediately supply the 'RAMP® Xpress' product to the global market through RBM's distribution network. This approach is intended to reduce the time and cost of launching a new brand and accelerate revenue generation.
The two companies will not stop at simple product supply but will expand their collaboration into a long-term joint research and development (R&D) partnership to develop next-generation POCT solutions. They aim to continuously introduce high-performance analytical systems and innovative diagnostic product lines tailored to the future demands of the global market and enhanced user convenience.
SugenTech's diagnostic platform features a flexible design capable of handling various sample types, and it utilizes time-resolved fluorescence (TRF) and fluorescence immunoassay (FIA) technologies to deliver a high level of precision on par with large-scale reference laboratories. Additionally, it significantly reduces the initial implementation and maintenance costs for medical institutions, giving it strong market competitiveness.
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A SugenTech representative stated, "Distributing our platform through the verified global brand RAMP® reflects recognition of both our technological maturity and market potential," adding, "We will further advance SugenTech's global POCT business value by capitalizing on the global distribution enabled by Canadian approval and by continuously investing in next-generation joint R&D with RBM."
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