Quick, robust testing method for diabetic comorbidities brings analysis out of the lab
The incidence of diabetes in Europe in 2017 is estimated at 8.8 % of the adult population (58 million), and set to rise to 10.2 % (66.7 million) by 2045. Comorbidity, (the co-existence of one or more additional conditions in people with a specified medical condition), is highly prevalent in diabetic patients. These include hyperlipidaemia, hypertension, renal impairment and ischemic heart disease, giving rise to longer term micro- and macro-vascular complications. According to the WHO, of the top 10 causes of death, diabetic comorbidities are at the top of this list (ischaemic heart disease), second place is stroke and diabetes alone is at seventh place – with incidence rates running at 9.4 5.8 and 1.6 million, respectively. “Hospital inpatient expenses are the largest cost category at 30 %, 35 %, 49 % and 65 % of overall costs in the United Kingdom, Germany, Ireland and United States, respectively,” explains Mr Jerry O’Brien, Chief Executive of Radisens Diagnostic, the company behind the MEDMICO project. The cost of managing the co-morbidities far outweighs managing diabetes alone as the former demand monitoring and care from a range of different clinical pathways. “Studies show that clinicians are more likely to change a patient’s clinical management if their diabetes monitoring is done at the point-of-care (POC) in the clinic, compared with laboratory testing. So, monitoring of diabetic comorbidities can improve patient outcomes at a lower cost to the healthcare system.” POC devices for testing a subset of diabetic comorbidities are on the market, requiring many drops of blood (and painful fingers!), refrigerated storage and complicated use. Which is where MEDMICO steps in. The project developed a platform, Gemini, that comprises a POC ‘desktop’ reader prototype and a series of test cartridges. “A drop of blood is applied to the test cartridge and put into the reader which runs the tests in a matter of minutes. We have test cartridges to monitor for diabetes, cardiovascular disease and kidney disease in development with other tests relating to inflammation and iron deficient anaemia in the pipeline,” says O’Brien. Each test cartridge contains biological reagents, such as enzymes, antibodies and other biochemical components that typically require refrigerated storage to maintain their function. Radisens is developing technology to protect these reagents from the environment, thereby allowing cartridges to be stored at room temperature while maintaining performance. As a result, the patient will not need to wait the 30 minutes, or more, required by competing technologies to reach room temperature from cold storage before the test is performed. This is especially important for monitoring these comorbid diseases in the physician’s office, pharmacy and retail clinics, and other decentralised clinics. “The fact that the tests will not need cold storage and are quick and simple to use also has the potential to be very useful in developing countries.” Along with developing the testing systems, the company has also spent part of the project’s time running method comparison studies internally, using clinical samples. These demonstrate that the Gemini platform is on course to meet the target of laboratory-grade performance and long-term stability. “We are most proud of the talented, multi-disciplinary and innovative teams who have developed the myriad of patented technologies all in-house. These include some of the toughest tests, in terms of assay performance requirements, smart microfluidic cartridges, reliable and easy-to-use device prototypes,” says O’Brien.
Keywords
MEDMICO, diabetes, cardiovascular disease, kidney disease, inflammation, anaemia, chronic disease management, comorbidity, healthcare costs, point-of-care testing
