First in Diagnostics – Solid-State Technology Device Accredited in EU

The CE marking has been given for healthcare professional use of a new PT/INR blood-testing disposable diagnostic strip as part of the world’s first accredited diagnostic device based on a micro-electromechanical system (MEMS).

The CE marking accreditation, achieved by Microvisk Ltd (St. Asaph, UK) for its CoagMax PT/INR system, is a major step forward in blood testing technology. Microvisk’s patented microcantilever sensor technology determines blood clotting speed from a finger-prick sample, with results displayed on its compact CoagMax handheld reader. The PT/INR strip, which uses the standard international PT (Prothrombin Time) or INR (International Normalized Ratio) test on a drop of patient’s whole blood from a finger prick, measures fluid viscosity, combining accurate, dependable, lab-quality results with exceptional ease of use. The strip sensors detect blood changes to a gel-like substance and assess whether viscosity is within acceptable range for the patient’s medication.

Patient clotting speed is measured by multilayered MEMS sensors, incorporating a cantilever on the strip surface to measure the fluid viscosity. An embedded microchip stores calibration data and the CoagMax reader automatically rejects any strip compromised by prior use.

“CE marking for CoagMax takes us close to the runway for product launch to the European healthcare professional market and beyond,” said Microvisk CEO Jim Thurlow. He added, “The achievement of CE marking of a medical diagnostic device based on a tiny MEMS sensor is a major milestone for Microvisk – and opens up further possibilities for this pioneering technology.”

Initial application of the technology is for monitoring patients taking anticoagulants such as Warfarin, to minimize risk from life-threatening blood clots and help manage correct dosage. Microvisk’s platform technology is unique in medical diagnostics as a robust, solid-state system with the simplicity to revolutionize point-of-care and home testing. With patients on anticoagulants needing regular tests to confirm correct dosage levels, there’s an increasing trend for self-testing at home. The Microvisk CoagMax reader and PT/INR strip enable patients to quickly and conveniently test blood clotting, as diabetics test for glucose.

The CoagMax PT/INR system is distinct from other existing technology, which relies on more complex and less user-friendly optical analysis or chemical reaction-based measurement. The CoagMax meter reduces healthcare cost as well as patient time and inconvenience for clinic attendance and laboratory services. Requiring only 8 µL of blood, less than competing systems, also means less pain for users.

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