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DualDur: A Disruptive Diagnostic Technology that Enables for the First Time an Early and Accurate Diagnosis of the tick-borne Lyme Disease.

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

Lyme borreliosis (LB) is the most common zoonotic disease in Europe with 650-850,000 estimated cases every year. Currently used serological tests for Lyme disease are highly unreliable in early stages of the infection. If the disease is not diagnosed and treated early on; the infection often spreads to joints, the nervous system, and the heart causing severe and potentially persisting symptoms. Late stage, disseminated LB is a heavy burden on the patients in terms of quality of life and direct and indirect costs. It is also a significant burden on the European healthcare system: most of the €1 billion annual cost of the disease is associated with late stage LB. Our patented DualDur reagent and method enables a more reliable early diagnosis of Lyme disease than currently used serological methods, as it is based on direct detection of the bacteria and does not rely on the immune response. In the present project we validated a novel testing procedure. This will allow the wide-spread application of DualDur, as it improves time-to-result by 10 to 20 times, and decreases personnel cost compared to our current procedure. Our improved reagent and new method of testing enables us to provide the DualDur tests all over Europe through partnerships with clinics and medical laboratories. More reliable early diagnosis of Lyme disease will reduce the number of later stage cases significantly. Additionally, DualDur will be the only proven test on the market that can verify a successful treatment. This in turn will improve the quality of life of patients and reduce the financial burden of the disease.
During the first year of the project, we made significant progress with the development of the DualDur Diag System, a novel solution enabling a faster evaluation of samples, with key modules of the system developed.
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.
The DualDur project is an answer to the ever growing and currently still unmet need of providing a simple, one-off screening test for Lyme Borreliosis. Medical Doctors are using several investigation and diagnostic methods, sometimes up to a value of € 1,000, and together with patients, are seeking for new, validated tools that they can understand and believe.
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.