CORDIS - EU research results

A patient-friendly blood collection device that produces pure plasma samples for simple laboratory analysis

Periodic Reporting for period 1 - HemaXis DX (A patient-friendly blood collection device that produces pure plasma samples for simple laboratory analysis)

Reporting period: 2019-09-01 to 2019-12-31

Blood analysis is undeniably one of the most powerful medical diagnostic tools. In most cases, blood tests are part of regular check-ups undertaken annually to diagnose certain abnormal values, such as low haemoglobin or sodium and potassium levels. In Europe, hundreds of millions of blood tests are performed monthly. However, blood collection techniques have not significantly changed since the 1950s and still require skilled healthcare professionals to attain adequate blood samples. In addition to an outdated process, before the blood is tested, it needs to be precisely prepared for analysis. Most routine laboratory tests are performed on plasma, a liquid component of blood which contains dissolved proteins, glucose, clotting factors, mineral ions, hormones and drugs. However, blood plasma preparation is a time consuming and costly process, with a multitude of problems.
Venepuncture is the most routinely performed procedure for blood collection. It is an invasive painful procedure as a needle is inserted in the vein to collect a blood sample. A variety of adverse complications and bacterial infections may be encountered during the blood collection process. In addition, during the collection or centrifuge processes to separate the red blood cells from the plasma, red cells might burst: this process is called haemolysis and it contaminates the blood sample, altering plasma values and consequently invalidating the results. Lastly, logistic costs account for up to 40% of the total laboratory budget. Treating venepuncture blood tubes requires large stationary equipment such as centrifuge and refrigerators, which are not present at home, in remote areas or in small laboratories where resources and employee training are limited. Laboratories also incur in costs for cold storage, centrifuge for plasma/serum separation and disposal.
DBS System developed HemaXis DX, a dried blood plasma spot device which uses microfluidics technology to passively and efficiently separate plasma from whole blood without centrifugation, filtration membrane or pump with no haemolysis risk. The device is coupled with protocols which are guidelines on how to run specific tests.
The objectives of the feasibility study were to evaluate technical and regulatory requirements for introduction of the HemaXis DX into the European market, optimise the design and define the technology validation activities.
DBS completed a full analysis of the technical and business potential of the HemaXis DX device. The interest of 2 international hospitals was secured, while the company established preliminary contacts with other European medical institutions.
DBS designed and secured a value chain which will be capable of supporting the company to efficiently deliver the required volume of HemaXis DX devices and identified the optimum sales channels.
DBS also identified the optimisation work required in the manufacturing process to effect scale-up within the scope of a Phase 2 innovation project. From a regulatory perspective, DBS designed a clinical validation study to prove the safety and efficiency of the HemaXis DX during the EIC Accelerator innovation project and identified the regulatory activities to progress towards the CE Mark in Europe. Furthermore, DBS calculated detailed four year financial projections for commercialisation and analysed the financial and infrastructure requirements for achieving global sales.
The expected outcome is to finalise the HemaXis DX optimisation activities, produce the first batch of complete and fully operating devices, and to complete clinical validation activities such that EU market readiness will be achieved by the end of the Phase 2 project. The adoption of the HemaXis DX will revolutionize the blood testing market, and generate tangible savings for the healthcare system both in the short and longer term.