1. What is RheumaKit?
2. How can you benefit from this test?
3. Where and when will RheumaKit be available?
4. History and Technology

What is RheumaKit?

RheumaKit is a new diagnostic solution for patients with undifferentiated arthritis. Currently, the tool allows to differentiate patients suffering from rheumatoid arthritis, seronegative spondyloarthropathy and osteoarthritis. The RheumaKit does not intend to bypass the expertise of the health care specialist in charge of the patient. However, its purpose is to deliver new and relevant information to allow an earlier diagnosis of undifferentiated arthritis. RheumaKit diagnostic accuracy is above 90% for RA diagnosis, a better performance than any other diagnostic algorithm designed until now, including the ACR/EULAR 2010 criteria for the diagnosis of RA.

Undifferentiated arthritis describes 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.It is a condition in which joint inflammation is present, but a precise diagnosis cannot be made with the currently available techniques. About 50% of the patients with undifferentiated arthritis will finally develop overt rheumatoid arthritis, a severe inflammatory condition of the joints, and the delay in making the diagnosis and initiating adequate therapy is harmful for these patients. If you suffer from undifferentiated arthritis, RheumaKit will help your rheumatologist or orthopaedic surgeon to make a relevant diagnosis and choose an adequate therapy up to around three years earlier than without using RheumaKit.

How can you benefit from this test?

The procedure is very simple: a doctor (typically a rheumatologist or an orthopaedic surgeon) orders a sampling kit directly from this web platform, and receives it at his office or his practice. He/she then performs a synovial biopsy, and sends us back the kit filled with your synovial biopsy. While the sample is being analysed at the certified RheumaKit laboratory, the doctor enters three clinical observations on a secured web page. A few days later, the differential diagnosis between rheumatoid arthritis and other types of arthritis, such as osteoarthritis or seronegative spondyloarthropathy is available for him/her online. The use of RheumaKit necessarily involves a medical doctor. The best way to get tested is thus to recommend RheumaKit to your rheumathologist or orthopaedic surgeon. He or she will be able to evaluate if RheumaKit is appropriate for you, and go through the few steps from ordering a kit to interpreting the results available on our web platform.

Where and when will RheumaKit be available?

RheumaKit is a validated test according to the European standard (CE marking in compliance with the directive IVD 98/79/EC) and is available in all EU countries. Doctors can already subscribe for free to the service and test a demo patient or order kits to help establish a diagnosis for their patients.

History and Technology

RheumaKit was initially developed jointly by teams of the Université catholique de Louvain and other Belgian universities, in the context of a BioWin program. Biowin is a governmental action supporting competitiveness and innovation in Southern Belgium in the field of biotechnologies and healthcare. The teams involved are experts either in Rheumatology, Molecular Biology, or Computing Sciences. DNAlytics, a Belgian company specialized in biological data analysis with applications in personalized medicine, brought this solution to the market and now ensures its distribution. RheumaKit measures the expression of around one hundred genes and also uses three clinical observations made by the doctor. RheumaKit then combines all these information through a dedicated algorithm and computes the most probable differential diagnosis.

1. What is RheumaKit?
2. For which patients is RheumaKit appropriate?
3. How to proceed?
4. Where and when will RheumaKit be available?
5. How to interpret the results?
6. Technological and scientific background

What is RheumaKit?

RheumaKit is a powerful, early and online diagnostic solution for patients with undifferentiated arthritis. The RheumaKit is a multi-gene expression solution that discriminate rheumatoid arthritis from other joint conditions. The diagnostic model is trained to identify patients suffering from rheumatoid arthritis, Seronegative Spondyloarthropathy or osteoarthritis. RheumaKit will help you, as a rheumatologist or orthopaedic surgeon, to make a relevant diagnosis about your patient suffering from undifferentiated arthritis and, as a result, choose an adequate therapy up to three years earlier than without using RheumaKit. RheumaKit diagnostic accuracy is higher than 90%, a performance that is better than any other diagnostic solution designed until now, including the new ACR/EULAR 2010 criteria for the diagnosis of rheumatoid arthritis.
For more details, please refer to the user instructions.

For which patients is RheumaKit appropriate?

RheumaKit is useful for patients suffering from undifferentiated arthritis. Undifferentiated arthritis describes 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. 30 to 50% of the patients with undifferentiated arthritis develop over time rheumatoid arthritis (RA). Another 20-30% have Seronegative Spondyloarthropathy (SNSA), i.e. arthritis in the context of spondylitis ankylosans, Crohn’s disease, psoriasis, uveitis, ... (although many patients do not present any sign of these conditions when the symptoms of arthritis develop). The remaining patients have minimal or more severe degenerative changes (osteoarthritis, OA), and the joint symptoms will either disappear or require symptomatic care. Septic arthritis is not part of the differential diagnosis proposed by the kit, and this condition needs to be carefully considered by the caring physician before any further processing.
For more details, please refer to the user instructions.

How to proceed?

Clinicians, typically rheumatologists or orthopaedic surgeons, can register for free on the secured web platform, and order sample collection and transportation kits containing vials filled with a RNA-preserving solution. Those are sent to their office or practice. They then perform a synovial biopsy on their patient. The detailed instructions for the biopsy are provided with the kit. Once the synovial biopsies are harvested, they are shipped to a central laboratory, where the expressions of a series of relevant markers are extracted. The diagnosis is computed and delivered through the same secured web-platform, based on the association of molecular data and clinical information provided on-line by the clinician (presence of psoriasis, rheumatoid factors, arthritis of the hands).
For more details, please refer to the user instructions.

Where and when will RheumaKit be available?

RheumaKit is available in EU since fall 2014. RheumaKit is a validated test according to the European standard (CE marking in compliance with the directive IVD 98/79/EC), based on clinical study data. Doctors can already subscribe for free to the service and test a demo patient or order kits to help establish a diagnosis for their patients.

How to interpret the results?

The RheumaKit web platform will provide a differential diagnosis between rheumatoid arthritis and other types of arthritis, such as osteoarthritis or seronegative spondyloarthropathy. The tool also provides a numerical and a graphical summary of the level of activity of seven metabolic pathways. The pathways considered are Chromatin Remodeling, T and B Cells Activation, Tumor Necrosis Factor (TNF), Type 1 Interferon, Extracellular Matrix, RAS-GTPase Activation and Hypervascularity. The metabolic pathways analysis is provided to the clinician as a complementary information based on the transcriptomic analysis of a synovial biopsy. It should not be interpreted as a clear recommendation for treatment orientation nor any other form of patient management recommendation. The description of each pathway provided results from a review of the literature.
For more details, please refer to the user instructions.

Technological and scientific background

RheumaKit was developed based on the high- and medium-throughput transcriptomic studies performed by teams of the Université catholique de Louvain and other Belgian universities, in the context of a project of the BioWin program. The related publication has been published on April 30th 2015 in PLOS ONE by Lauwerys et al. : “Heterogeneity of Synovial Molecular Patterns in Patients with Arthritis”. Biowin is a governmental action supporting competitiveness and innovation in southern Belgium in the field of biotechnologies and healthcare. The teams involved are experts either in Rheumatology, Molecular Biology, or Computing Sciences. DNAlytics, a Belgian company specialized in biological data analysis with applications in personalized medicine, ported this solution to the public and now ensures its distribution. The researchers involved in the design of RheumaKit performed high-density gene expression studies on synovial biopsies from patients with arthritis, and found that gene expression profiles in these biopsies were strikingly different according to the underlying condition. Other than diagnosis, the researchers are now also working on the identification of markers of disease severity, and response to therapy. The RheumaKit opens a new era in the care of patients with arthritis. What we are interested in, is not just delivering a diagnostic label, but also individual prognostic and theranostic information, based on well-characterized molecular and clinical profiles. RheumaKit also received awards respectively from FlandersBio (Knowledge for Growth 2013, Ghent, Belgium), from the European Commission (EU SME eHealth Solution Competition 2013, Dublin, Ireland), and from the Massachusets Institute of Technology (MIT Innovators under 35, 2015).