Hasselt Univ. and INOVA Diagnostics have announced the completion of an exclusive, worldwide license agreement and research collaboration for technology developed at the university. This technology represents an important advance in the diagnosis of rheumatoid arthritis (RA). VIB, the Flemish life sciences research institute, assisted Hasselt Univ. in patenting the RA markers and in the license negotiations.
"Delaying diagnosis of RA can impact the quality of life of affected patients. New biomarkers can aid in achieving better outcomes based on appropriate treatment at an earlier stage of this disabling disease. We believe that the markers identified by the world class immunology researchers at Hasselt Univ., combined with the assay development expertise at INOVA Diagnostics, should result in an enhanced capability to accurately diagnose RA patients who are seronegative by existing markers," said Michael Mahler, PhD, VP of R&D of INOVA Diagnostics.
Initial studies by Hasselt Univ. showed that these biomarkers hold great promise for improved diagnosis. Approximately one-third of RA patients are negative for the two serological markers that are predominantly used in the diagnosis of RA: rheumatoid factor (RF) and anti-cyclic citrullinated peptides (CCP). While third generation CCP assays (CCP 3.0 and CCP 3.1) have increased sensitivity in early disease, some RA patients remain seronegative.
The aim of the initial Hasselt Univ. study was to identify additional autoantibody markers for seronegative RA and early RA. All early RA patients were positive for at least one of the 14 novel autoantibodies, and antibody positivity was associated with a shorter disease duration (P = 0.0087). 52% of RA patients who initially tested negative for RF and CCP were positive for at least one of the 14 novel autoantibodies, resulting in a 19% increase in sensitivity compared to current serological testing. Moreover, five of the novel autoantibodies were detected more frequently in seronegative RA patients, indicating that these autoantibodies constitute novel candidate markers for this RA subtype. "We are excited about the potential of these novel markers to identify early RA patients who are seronegative with existing markers. We are pleased to partner with INOVA Diagnostics, the global market leader in autoimmune diagnostics, and together we look forward to validating these markers in additional patient populations," said Professor Veerle Somers, head of the biomarker research program at the Biomedical Research Institute (BIOMED) of Hasselt Univ.
"It was great for VIB to be involved in the discussions between Hasselt Univ. and INOVA Diagnostics and to see the complementarity between the two parties, which is always the best basis for successful partnerships," said Dr. Karine Clauwaert, Senior Business Development Manager at VIB.