Biomarkers Hold Promise for Improved Diagnosis of Rheumatoid Arthritis

Novel biomarkers have the potential to identify early Rheumatoid Arthritis (RA) patients who are seronegative with existing markers.

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 anticyclic 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 a study by the Hasselt University (Hasselt, Belgium) 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). Fifty-two percent 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. 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.

Hasselt University and Inova Diagnostics (San Diego, CA, USA) completed an exclusive, worldwide license agreement and research collaboration for technology developed at the University. This technology represents an advance in the diagnosis of Rheumatoid Arthritis (RA). VIB, the Flemish life sciences research institute, assisted Hasselt University 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 University, 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, vice president of Research and Development of Inova Diagnostics.

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Hasselt University
Inova Diagnostics