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 centered around RheumaKit, DNAlytics’ 1st 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 diagnostis 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 ‘rheumakit.com’ performing the effective diagnostic computation on scalable cloud-computing infrastructure. By improving the UA patient management, RheumaKit should improve the health of millions of patients, and reduce societal burden related to arthritis.
In the Phase 1 of ADDITION, DNAlytics received the CE marking for the RheumaKit current indication, performed an in-depth market survey, including 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, identification of new needs and development of corresponding new features on rheumakit.com , investigation about reimbursement landscape in EU, and of course, future clinical study specification.
With these results, DNAlytics is now ready to submit a Phase 2 proposal in order to perform a large clinical study including up to 10 clinical centers across Europe and recruit up to a thousand arthritis patients.
Disclaimer: This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 662712. This communication reflects only the author’s view. The Executive Agency for Small and Medium-sized Enterprizes (EASME) of the European Commission is not responsible for any use that may be made of the information this page contains.