Medical device innovator Microvisk Ltd. has achieved CE marking for healthcare professional use of the world’s first disposable medical diagnostic strip based on a Micro-Electro-Mechanical System (MEMS). Accreditation paves the way for commercial product launch, starting with the UK and extending to export markets within coming months. A major step forward in blood testing technology, the North Wales company’s patented, microcantilever sensor technology determines blood clotting speed from a finger prick sample, with results displayed on its compact CoagMax® handheld reader. Initial application of the Microvisk technology is for monitoring patients taking anti-coagulants such as Warfarin, to minimise risk from life-threatening blood clots and help manage correct dosage. The CoagMax® PT/INR system, incorporating the MEMS technology on a disposable test strip, enables rapid testing in an easy-to-use, portable format.
The CE mark denotes mandatory compliance with all applicable EU Directives for diagnostic medical devices – effectively clearing products for sale in the European Economic Area, including the UK.
Authorised under the EC Declaration of Conformity, the CE Mark is an essential prelude to seeking regulatory approval by the US Food and Drug Administration (FDA) for sales across US healthcare markets.
Microvisk’s platform technology is unique in medical diagnostics as a robust, solid state system with the simplicity to revolutionise point-of-care and home testing. The PT/INR strip measures fluid viscosity, combining accurate, dependable lab quality results with exceptional ease of use.
"CE marking for CoagMax® takes us close to the runway for product launch to the European healthcare professional market and beyond", said Microvisk Ltd. 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.
"Bringing MEMS technology into the medical device market is a real step change, unlocking the potential of advanced technology to create smaller, simpler-to-use devices for the growing healthcare diagnostics market."
The company estimates that by 2023 the potential EU market for the device could reach US $350m.
In context, self-monitoring and point-of-care testing are major drivers in the projected 7% annual growth in the IVD market in the next few years. The global market is currently valued at US $49.2 bn - rising to over US $69bn by 2017 – when it is estimated that the point-of-care PT/INR segment will exceed US $1bn.
Beyond medical diagnostics, Microvisk’s technology platform has future potential for numerous fluid viscosity testing applications –with oils and foodstuffs being prime examples.
To combat the risk of clotting conditions, including heart attack, stroke and DVT, an estimated 10 - 12 million people in the Western world take anti-coagulants (blood thinners). In the UK, prescription of anti-coagulants in 2013 showed an annual increase of over 10%.
With patients on anti-coagulants needing regular tests to confirm correct dosage levels, pressure on healthcare resources and successful trials are fuelling an increasing trend for self-testing at home, led by Germany and the USA.
The Microvisk CoagMax® reader and PT/INR strip enable patients to quickly and conveniently test blood clotting just as diabetics test for glucose.
CoagMax® and its disposable strip are clearly distinct from competitors’ existing technology, which relies on older, more complex and less user-friendly optical analysis or chemical reaction-based measurement.
Taking the CoagMax® meter to the finger reduces patient time and inconvenience for clinic attendance, while eliminating the need for a laboratory. Requiring only 8 ul of blood – less than competing systems – also means less pain for users.
Patient clotting speed is measured by multi-layered MEMS sensors, incorporating a cantilever on the strip surface to measure fluid viscosity. An embedded microchip stores calibration data and the CoagMax® reader automatically rejects any strip compromised by prior use.
The strip uses the standard international PT (Prothrombin Time) or INR (International Normalised Ratio) test, by using a drop of patient’s whole blood from a finger prick. The sensors detect blood changes to a gel-like substance and assess whether viscosity is within acceptable range for the patient’s medication.
Microvisk’s R&D success in miniaturising the MEMS technology has been the key to potential future high volume production of the PT/INR strip at low unit cost.
Microvisk’s main operations are based on the St Asaph Business Park. Facilities include instrumentation/clinical development labs. and a clean room component production facility. Prototyping, sensor and MEMS technology are focused at Oxford Business Park.
The company is funded through private and venture capital investors, including Oxford Technology, Finance Wales and Porton Capital.