Periodic Reporting for period 2 - DualDur (DualDur: A Disruptive Diagnostic Technology that Enables for the First Time an Early and Accurate Diagnosis of the tick-borne Lyme Disease.)
Reporting period: 2019-04-01 to 2020-06-30
We carried out an international, prospective clinical study within a standardized framework to provide reliable clinical data for the validation of testing methods based on DualDur. The data shows that DualDur cell technology medium and preparation method, together with our software using artificial intelligence qualifies as a potential screening test at Lyme clinics. Detailed results of the clinical study are expected to be published in the first half of 2021, subject to peer review.
We have established the necessary basis for the successful commercialisation of the project results. The market research carried out in key potential markets has confirmed our initial calculations and showed a market growth that is beyond our earlier expectations. Based on this we refined our business plan and commercialisation strategy. From the beginning, we have been improving the investment readiness of our project and intensified our cooperation with potential trade partners. Our IP portfolio was also extended; and we obtained CE marking for DualDur.
In addition, a comprehensive communication plan has been prepared to promote and disseminate project results to key stakeholders, with initial measures already implemented.
Scientific publications are thriving in the subject, government hearings are going on in the US to better understand the issues from the past decades, new legislation is being prepared in the EU, new codes have been approved by the WHO for various states and forms of Lyme disease. The yearly number of new cases in the US is now estimated 42% higher than a few years ago.
Solutions based on DualDur will contribute to faster, easier and more cost efficient diagnosis of Lyme Borreliosis, even in the early stage of the disease when severe symptoms and consequences can still be avoided.
Lyme disease is caused by spirochetes Borrelia Burgdorferi s.l. which are present in the blood, and can be found at all times during an infection, after a tick “injects” them into the blood-stream through capillaries. Our DualDur reagent & method concentrates the scarce spirochetes present in the blood. At the same time, DualDur differentiates the spirochetes from other cellular structures, enabling a morphological investigation by dark-field microscopy.
The market of Lyme diagnostics is now growing double-digit in key European countries. According to our updated business plan, with respect to the most recent studies carried out by our team and independent analysts, it seems achievable that with a next level investment we can hit a significantly higher market share within this faster growing market, and compared to the earlier estimates, double the impact of the project in Europe.