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Improving Safety and comfort for kidney transplanted patients by enabling Accurate therapeutic drug monitoring through quantitative Capillary home Sampling

Periodic Reporting for period 1 - ISACS (Improving Safety and comfort for kidney transplanted patients by enabling Accurate therapeutic drug monitoring through quantitative Capillary home Sampling)

Reporting period: 2019-05-01 to 2019-10-31

The objective of this SME Phase 1 study was to conduct a feasibility assessment and develop a business plan for the use of Capitainer’s home blood sampling devices in the field of Therapeutic Drug Monitoring for kidney- and liver transplant patients. Previously, we have identified the follow-up of patients after an organ transplant as the primary entry point for the application of our technology. Transplant patients require lifelong continuous blood-based monitoring to ensure the success of the transplantation procedure. Currently, blood extraction is performed through venepunctures executed by trained phlebotomists at hospitals or healthcare centres. This approach disrupts the everyday lives of patients and overburdens the healthcare system. The need for innovation is clear and we have identified a significant demand for the development of accurate “use-at-home” blood sampling tools that can alleviate this heavy burden. The need for blood sampling extends throughout the field of medicine as about 70% of all medical decisions are based on some form of laboratory analysis, where blood is by far the most common sample.
Assessing technical feasibility is based on feedback that we obtained from health care professionals and patients. The gained feedback is translated into device specifications and will help improve our market strategy. We gathered opinions from well-recognised experts in the field of medicine and pharmacology that were Key Opinion Leaders (KOL’s) for our project. Their valuable contributions allowed us to validate our products. The opinions were very positive and gave a high mark to our project. These opinions are even more valuable because of the vast experience of KOLs. Their experience in medical, pharmacological and analytical aspects of transplantology guarantees that their opinions reflect all aspects of the topic. Moreover, they have enormous experience in the functioning of transplantation medical care in Scandinavia and the whole of Europe. Professor Anders Åsberg is the principal investigator in the Department of Transplantation Medicine at Oslo University Hospital and Head of Laboratory and CEO of the Norwegian Renal Registry. Professor Bo-Göran Ericzon is Head of Division of Transplantation in Surgery Department of Clinical Science, Intervention and Technology of Karolinska Institutet. Professor Christophe Stove from Ghent University has vast experience in analytical chemistry. Neil Spooner has broad experience both in research and business development.
Capitainer®B was developed as a response to the need for home blood sampling technology. Capitainer®B is a portable, affordable, cost-effective and easy-to-use microsampling system which enables the patient to take a quantitative dried blood spot samples (DBS) by themselves. The samples can then be shipped to laboratories via regular mail for further analysis. The present SME Phase 1 study has confirmed the technical and market feasibility of Capitainer®B. Our prototypes have proven to be robust and attracted the interest of Key Opinion Leaders, end-users and potential customers. However, the key finding of this study was the need for a plasma sampling counterpart to Capitainer®B. While Capitainer®B enables the remote monitoring of immunosuppressive drugs’ levels – a crucial component of post-transplant care— it doesn’t cover all the analyses necessary to ensure transplant success. Many crucial laboratory tests require plasma, rather than blood, and in order to obtain plasma from a blood sample and prepare it for subsequent analysis, the patient must be present at a healthcare facility. Thus, to truly ease the burden on patients and the healthcare system a combined blood and plasma remote sampling solution is required. This finding is the driving force behind the development of Capitainer®P – an autonomous home plasma sampling device that filters and stores an exact amount of plasma as a dried plasma spot (DPS). The combination of Capitainer®P and Capitainer®B offers a unique value proposition. To date, no player has demonstrated a technology capable of collecting both blood and plasma in a home-environment to an extent that allows for the performance of all critical analytical chemistry tests. The findings of this SME Phase 1 study provide the ground for a forthcoming EIC Accelerator project. In that project, we will develop, validate, and implement assays for immunosuppressants on Capitainer®B and the most commonly monitored organ function markers on Capitainer®P. This will allow home sampling for liver- and kidney transplant patients for the first time ever.