A Marie Curie project has brought together researchers from Europe and China to create a new method for diagnosing and monitoring the evolution of diabetes. Thanks to a simple urine test, patients will soon benefit from solutions that are simpler to use, more cost efficient and more effective than any other method currently available.
While simpler than blood glucose tests, urine tests for diabetes have so far been less reliable than blood glucose level ones. Finding disease-specific protein biomarkers in urine is not an easy task, as these proteins can vary quickly and significantly due to changes in diet, metabolic or catabolic processes, circadian rhythms, pharmacology, exercise, as well as the circulatory levels of various hormones. Last but not least, environmental and genetic factors also influence the rate of disease progression, which implies that the biomarkers of patients from different regions of the world would not necessarily have the same characteristics.
The EU-backed UROSENSE (Biomarker Applications for Nanotechnology and Imaging in Diabetes) project, which was completed in December 2015, aimed to overcome this lack of suitable, easy and accessible urine-based test methods to combat the rapid expansion of diabetes globally. The project team — led by Dr Harry Holthofer from Dublin City University — managed to create an easy-to-use, non-invasive system thanks to a thorough analysis of high-quality standardised data.
This test, which has been trialled on patients from China and Europe, can be used as point-of-care testing at home to screen patients rapidly and help them to postpone and even completely avoid the onset of diabetes. It will eventually save pre-diabetics from hospitalisation and contribute to significant savings in healthcare expenditure.
What can you tell us about the biomarkers you identified in your research?
Dr Harry Holthofer: Our research allowed us to identify a number of useful biomarkers which can be found in the patient’s urine. The new method we use to find these biomarkers, ‘Hydrostatic filtration dialysis’ (HFD), is by far superior to all existing practices. It’s simpler, more cost-efficient, and more effective in revealing potential biomarkers.
Moreover, our method radically cuts the time needed to exploit the biomarker source in studies and is also allowing for much simpler sample storing, for example in developing countries. This is an important aspect, as more and more sample collections for biobanks are currently being used to store samples for later analysis. Our method reduces the need for storage capacity (freezers) to less than one tenth of what was previously required.
Your main objective was to develop a non-invasive urine test to screen patients. Are you happy with the results?
We are very happy with the new method established: it provides a vast number of potential new ways to better understand disease mechanisms as well as identify target pathways and molecules for pharmacological intervening. Moreover, it provides a new path for improved, simple home-test and mobile health applications for patients to manage diabetes easily in their everyday life. After full validation, we hope our method will result in much simpler diabetes management with a completely painless test system utilising urine.
How does this test compare to previously-used methods?
We have solid data to show that our test system can efficiently provide initial biomarker information on diabetes progress in a much simpler format. This system currently looks set to replace the costly, labour-intensive and often highly technical methods used in the hunt for biomarkers, not only for diabetes but also for other diseases, including cardiovascular, infectious and kidney diseases. So I would say that our HFD method is a highly promising new platform that can be used for many futuristic diagnostics purposes.
How effective would you say the new test could be in helping to avoid the onset of diabetes?
We strongly believe that identifying both the risk of diabetes and the risk of costly diabetic organ complications like diabetic kidney, cardiovascular, skin and eye complications should be the future pathway for reasonable risk management at a personal, societal and national level. This will not only prevent excessively early invalidation, but also prove to be a very cost-efficient driver in future healthcare.
Have you tested your method on patients yet?
We have provided the first results in European and Chinese diabetic patients at different disease stages. We can detect typical urinary biomarker characteristics for European patients with notable differences compared to Chinese diabetes patients. As the number of diabetic patients increases rapidly in China, with already around 100 million patients, there is an urgent need to learn more about the disease traits and eventually prevent the massive costs this growth will imply in the future. This is why we have expanded, with the precious help of our UROSENSE partners in China, our network in that country. We have already seen highly encouraging exploitation of our method there, and this networking in China is expanding rapidly.
How do you keep potential data quality issues under control?
Thanks to help from our partners Tethis in Milan and Chimega Inc. in Hong Kong, quality by design, fulfilment of all relevant regulatory issues and compliance with ISO standards have been of major importance from the very beginning of the project. This approach was key to our method’s potential for commercial exploitation.
When it comes to data quality of our first scientific results, we have followed all key principles of responsible research so that our results can be reproduced with ethics and other aspects being considered. The shift from lab to market was built into the research design early on and we not only provided the proof of principle in practice but also confirmed our results in various ethnicities.
This is important, as more and more study results from regions like the Far East, and most notably China, are being published. With our method, we can simplify the protocols of ‘Standard operational procedures’ (SOPs) to be applied all across the world and, consequently, allow results from patients coming from different geographic areas for improved analysis. This is key to understanding phenotypic differences in disease biomarkers and, hopefully, will lead the way to better disease management at the local level. This all calls for controlling data quality from the very beginning.
The market potential of your test appears to be huge, as it can be conducted by patients at home. When do you expect commercialisation to take place?
We are currently working hard to overcome any hindrances to the exploitation of our method. For us, it is important to continuously progress in China due to its massive diabetes problem and also because of the easier access to this vast market. Unlike Europe, China has only one regulatory body, which has made it worthwhile putting all the effort in during the project in order to increase visibility of our results and raise market knowledge.
Building a deeper and deeper understanding of the decision-making process and key national decision makers in China has helped a lot in proceeding to tangible first-generation products which are, hopefully, only months away from commercialisation.
Funded under FP7-PEOPLE
Source: An interview from research*eu results magazine n. 50 p.6-8