Currently, seven million people in the western world use Warfarin to treat blood coagulation (clotting) disorders such as atherosclerosis and deep vein thrombosis. The U.S. Food and Drug Administration estimates that nearly 1 million patients will be prescribed the drug each year. In order to ensure they receive the correct dosage of the drug, patients must have regular blood tests at their doctor’s office. The drug requires this testing because everyday activities and foods can affect dosages levels.
According to a recent study at the University of Oxford in the UK, patients who monitor their own blood coagulation levels and Warfarin dosages can reduce their risk of blood clots by half.
Microvisk’s CoagMax® & CoagLite®
Microvisk’s two devices – the CoagMax® and CoagLite® tests allow patients and healthcare professionals a new testing technology to provide the Prothrombin time or INR (international normalized ratio), which is the internationally recognized standard in measuring blood coagulation. All of the currently available tests use the same approach to find the INR – taking a blood sample from the patient and measuring the clotting factor on a test strip. However, most available devices use optical analysis or chemical reactions.
The Microvisk uses micro electro mechanical sensors (MEMS) to measure blood clotting speed. The real difference in this SmartStrip® is that it allows patients to accurately measure their blood clotting levels at home with a single drop of blood and a handheld reader displays the results, much like a blood glucose monitor. The small testing sample is less intrusive and effectively removes the need for a laboratory.
The coagulation status (clotting speed) of the patient’s blood is measured by tiny multi-layered paddles on the surface of the strip and a memory chip ensures the device is calibrated to provide the highest levels of accuracy. The MEMS technology, which was originally developed as a movement system for nano-robots is also used in devices such as the iPhone and Nintendo Wii. This technology is cost-effective and allows for high volumes of the Microvisk devices to be manufactured at a low cost.
Currently, only three companies have developed a blood coagulation testing system approved for use in a doctor’s office. Although these devices are also certified for home use, Microvisk’s research shows that doctors feel they are “too robust” and “too complex” for home use.
The Microvisk devices are currently undergoing clinical trials in the UK and in Germany. Product launches are planned for these two countries in early 2012. In addition, U.S. clinical trials are ongoing in major medical centers in Florida; and the U.S. product launch is scheduled for later in the year.
A key finding in the pilot trials is that nine of 10 patients have expressed a preference for the Microvisk devices due to the small test sample needed.
Microvisk’s devices were named “Healthcare Project of the Year” at the prestigious BioNow Biomedical Awards, a showcase of the leading biomedical companies in northwest England in December.
Microvisk presented its products and technologies at OneMedForum SF 2012, on January 9 – 12.