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Report

Teaser, summary, work performed and final results

Periodic Reporting for period 1 - COMBO (A diagnostics platform for dengue fever and mosquito-borne diseases)

Teaser

Summary

What is the problem/issue being addressed?
The world is facing enormous challenges from the spread of infectious diseases. According to World Health Organization (WHO), mosquito-borne Neglected Tropical Diseases (NTDs) are among the most dangerous, in particular the ones transmitted by the female Aedes Aegypti mosquito, the primary vector for dengue (DENV), zika (ZIKV), chikungunya (CHIKV) and yellow fever (YFV) virus. Mosquito-borne diseases together kill more than 700,000 people every year, and Aedes mosquito presence is reported in more than 120 countries. Outbreaks have even been reported in the southern part of Europe and US. Dengue is the most common and dangerous of those mosquito borne viral infections. The infection causes flu-like illness and can occasionally develop into a life-threatening form as dengue hemorrhagic fever (DHF) or dengue shock syndrome (DSS). While dengue in most cases is not fatal, it still causes more than 20,000 deaths yearly.

Why is it important for society?
Dengue mostly prevails in tropical and subtropical areas, with 390 million cases/year, costing billions of dollars every year to the population and the healthcare ecosystems. Hospitals in dengue endemic areas can receive massive number of patients in high dengue season (up to few hundreds/day), but typically have availability of hospitalization beds for only a fraction of those (less than 20%). It is thus critical to be able to correctly distinguish patients who could potentially develop DHF/DSS, to be immediately hospitalized, from uncomplicated dengue forms, to be refereed home and monitored every three days. Each time a facility wrongly enrolls a patient in its dengue management program, it wastes the associated money and it reduces the availability of resources for real dengue cases. And each time a facility fails to enroll a dengue-positive case, it causes the patient a potentially long and debilitating recovery period (with higher risk of death), with the associated cost implications for the society. It is estimated that more than â‚¬200M are wasted every year only in Thailand, Malaysia and Vietnam.

What are the overall objectives?
BluSense Diagnostics has developed an innovative nanotechnology-based point-of-care blood testing platform for detecting dengue fever. With a single drop of blood, we can within minutes and with very high accuracy, test whether patients have been infected with dengue fever. The technology will be a major step forward in the treatment of dengue in areas around the world, where dengue is a serious threat. Our first dengue diagnostic blood-test has been ready for sales since Q2 2018. The overall objective of the project is to enable BluSense to move from a single and narrow product (ViroTrack Dengue Acute) produced in low-volumes, to a full diagnostic dengue platform (Virotrack Dengue Combo) produced on a high-throughput automated line, and to facilitate the market entry with pre-sales activities in terms of e.g. local regulatory approval and training. With the Virotrack Dengue Combo platform we can not only diagnose if patients are infected with dengue, but also test the severity of the infection. Hence is becomes much easier to advice the right treatment. Beyond this project, the aim is to further develop the Virotrack Dengue Combo platform into a generic infectious disease platform.

Work performed

During the first reporting year, BluSense Diagnostics delivered WP2 (ViroTrack Dengue Combo Integration) reaching therefore the first milestone M1, Design file for production of Combo cartridge (frozen design).In addition, the company submitted WP8 and an amendment with a revised and extended plan. The amendment relates primarily to WP3 and WP4. However, the adjustments of this crucial deliverables influence almost all work packages. The amendment has been submitted in April 2019 and accepted and signed by the EU the 15th of May 2019. BluSense Diagnostics also started to carry out work in different work packages of the project, which are not completed yet:

WP3
- Transfer cartridge production methods to manufacturing in existing pilot production line, incoming good controls, quality control steps establishment, development of instruction for use, labels and suitable cartridge controls (positive and negative).
- Ensuring process compatibility with all IVD standards (ISO13485 IEC 60601-1 IEC 60601-1-2 IEC61000-4-2 IEC61000-4-3 ISO62304)
- Analytical and clinical verification according to CE-IVD directive (ISO standards, CLSI guidelines) to prove reproducibility, stability (storage and transport simulation), sample type equivalence (finger-prick vs venous blood/ plasma), cross-reactivity, usability engineering and production tolerances on product performances.
- Create report of assay performance and comparison with state of the art methods to compile IFU), WP4, WP6, WP7)

WP4
- Recruit employees with experience in large volume IVD manufacturing
- Evaluate options where to locate the production line (DK, EU, outside of EU), transport method, logistics
- Obtain competitive quotations for each process station

WP6
- Approval / auditing of suppliers, review of Quality Assurance Agreements with suppliers, ensure that all tasks are documented according to BluSenseâ€™s QMS
- Support relating to development documentation, process documentation and training of employees

WP7
- Establish contacts and negotiate deals with local distributors in Region B and C. Sign agreements in at least 2 countries in Region B (Ideally Philippines and Indonesia) and at least one country in Region C

Final results

BluSense Diagnostics has developed an innovative nanotechnology-based point-of-care blood testing platform for detecting dengue fever. With a single drop of blood, we can within minutes and with very high accuracy, test whether patients have been infected with dengue fever. The technology will be a major step forward in the treatment of dengue in areas around the world, where dengue is a serious threat. Our first dengue diagnostic blood-test has been ready for sales since Q2 2018. The overall objective of the project is to enable BluSense to move from a single and narrow product (ViroTrack Dengue Acute) produced in low-volumes, to a full diagnostic dengue platform (Virotrack Dengue Combo) produced on a high-throughput automated line, and to facilitate the market entry with pre-sales activities in terms of e.g. local regulatory approval and training. With the Virotrack Dengue Combo platform we can not only diagnose if patients are infected with dengue, but also test the severity of the infection. Hence is becomes much easier to advice the right treatment. Beyond this project, the aim is to further develop the Virotrack Dengue Combo platform into a generic infectious disease platform.

the work is devided into 7 workpackages, where WP2-3 relates to the development and validation of the new cartridge, WP4-5 relates to building a production line to handle the expected increase in sales, WP 6 relates to quality assurance of all parts of the project, and WP7 relates to pre-market launch activities.

In the first year, the focus has mainly been on developing the new cartridge, where 2 deliverables has been finalized, namely a report on the new assay\'s performance, and design freeze of the new cartridge. Apart from these main results, work has also been progressing on all the other WP\'s even though the next deliverable is only in September 2019.