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 rheumakit.com 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.
