Radisens is developing a novel in-vitro diagnostics platform for point-of-care use. The Radisens point-of-care platform – Gemini™ – uses a novel centrifugal microfluidic cartridge approach combined with proprietary dried reagent assay protocols based on immuno-turbidimetric and clinical chemistry principles. The Gemini™ point-of-care reader automatically runs these protocols on the single-use cartridges before producing a result using optical detection methods. Gemini™ core technologies are protected by several granted patents.
Gemini™ leverages the many advantages of centrifugal microfluidics such as controlled liquid transport, metering, plasma separation, mixing and valving, enhanced by proprietary assay chemistries. Reagents for agglutination and enzymatic/colorimetric tests (single- & dual-phase) are formulated, concentrated and dispensed onto injection moulded cartridges and subjected to a proprietary multi-parameter controlled reagent drying process, which lends itself to rapid on-cartridge rehydration, long-term stability and scale-up.
A point-of-care Ferritin test is being developed on Gemini™ for the management of iron deficiency from whole blood. Additional assays have been prototyped to various stages of development including diabetes (HbA1c), cardiovascular disease (lipids panel), kidney disease (creatinine) and inflammation (C-reactive protein).
Method comparison data with clinical samples are available for HbA1c, Lipids (TChol, Trigs, HDL-C) with long-term stability data for accelerated and real-time storage conditions. Preliminary data for Ferritin, Creatinine, measured LDL-C, and C-reactive protein are available also. System precision for the reader and cartridge cuvette is <0.5% with assay incubation tolerance of ±0.1°C. Over 100,000 cartridge prototypes have been moulded to date for assay and process optimisation studies.
Radisens’ 10,000 sq. feet leased facility includes fully equipped assay development and formulation labs with a Beckman AU480 chemistry analyser, a rapid prototyping machine shop with a Datron M8Cube CNC machine and an environmentally controlled prototype assembly line with reagent drying chambers and cartridge assembly equipment.
Our multidisciplinary team has expertise across: