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Arthritis Differential DIagnostic validaTION

Periodic Reporting for period 1 - ADDITION (Arthritis Differential DIagnostic validaTION)

Reporting period: 2015-04-01 to 2015-09-30

DNAlytics' core expertise is to apply advanced algorithmic techniques to develop innovative marker-based diagnostic, prognostic and theranostic solutions. It has been granted an SME Instrument Phase 1 in response to the topic Clinical research for the validation of biomarkers and/or diagnostic medical devices (PHC12). The project named ADDITION (Arthritis Differential DIagnosis and Theranosis validatION) is centred around RheumaKit, DNAlytics' first product, in the field of Arthritis.

Arthritis is a group of persistent and progressive diseases with a huge health and socio-economic impact worldwide. Improving arthritis management requires to improve the early arthritis (EA) differential diagnostic and improve the adequacy of the therapeutic strategies.

RheumaKit is a first step in the introduction of biomarker-based in vitro diagnostic (IVD) tools in rheumatology to be used by rheumatologists and orthopaedic surgeons. It is a solution for the early differential diagnosis of patients suffering from undifferentiated arthritis (UA). UA is a subclass of EA and is a condition in which synovial inflammation is present in one or more joints, and no definite diagnosis can be made using presently available diagnostic criteria. RheumaKit consists of three main elements: a synovial biopsy collection/transportation kit, a central laboratory procedure, and a web application '' performing the effective diagnostic computation on scalable cloud-computing infrastructure.

The objective of the ADDITION project is to validate RheumaKit in its current indication (differential diagnosis of “difficult” early arthritis patients), and also to extend the RheumaKit indication towards treatment strategy guidance, by showing that it can predict the efficacy or non-efficacy of treatments against rheumatoid arthritis, knowing that those treatments are currently only effective for 50-70% of the patients, while being at the same time a very significant part of EU national health insurances expenditures. These two applications of the RheumaKit will be validated through a large clinical program. The Phase 1 project intended to set up this program, by contacting Key Opinion Leaders in Rheumatology across Europe, to identify and convince rheumatology clinical departments to join our project, to identify and approach the other necessary stakeholders, and to refine the market analysis.

By improving the arthritis patient management, RheumaKit should improve the health of millions of patients, and reduce societal burden related to arthritis.
As the Phase 1 project has reached its end, we can say that all objectives have been reached, through all the efforts undertaken, and even more : market study (KOLs meeting, dissemination of the scientific and business aspects of RheumaKit, Key Success Factor/Risk analysis, Patient associations meeting, regulatory analysis and market access), clinical trial preparation, partners/service providers identification, IT specifications and even already additional software development on

For the results, see next section.
In the Phase 1 of ADDITION, DNAlytics received the CE marking for the RheumaKit current indication. DNAlytics also performed an in-depth market survey which includes: interviews with more than 50 Key Opinion Leaders in 7 EU Countries, key success factor identification, contacts with patients associations, presence at a dozen of international congresses, field testing of the current RheumaKit solution in 4 EU countries, development of new features on based on newly identified needs, making a first step towards treatment choice guidance, investigation about reimbursement landscape in EU, and of course, future clinical study specification.

The ADDITION study has been designed to provide an answer to an unmet medical, economic and thus societal need in rheumatology. The expected socio-economic impact of this project is to improve significantly the health-economics in a domain where treatments (anti-TNF) represent one of the highest expense for the national health insurance agencies in Europe. With RheumaKit, we expect that not only the level of effectiveness of anti-TNF treatments will be improved (via the RheumaKit treatment response prediction), but also that some patients who are currently incorrectly diagnosed will not receive an unnecessary and expensive treatments in the future (via the RheumaKit improved diagnosis).

RheumaKit, while improving the patient health status by an early diagnosis, should at the same time generate significant direct savings linked to the avoidance of expensive and ineffective treatments, like anti-TNF, thanks to the selection of an adequate personalized therapy.

Having gathered a large amount of information in the phase 1, DNAlytics just submitted a Phase 2 proposal in order to implement the conclusion of this feasibility study. This will involve performing a large clinical study including up to 10 clinical centers across Europe and recruit up to a thousand arthritis patients.
RheumaKit differential diagnosis and metabolic pathway analysis.