New Biomarkers in Rheumatoid Arthritis

-- Hasselt University and INOVA Diagnostics Enter into a Research Collaboration and License Agreement for Novel Diagnostics

HASSELT, Belgium and SAN DIEGO, Oct. 28, 2013 /PRNewswire/ -- Hasselt University and INOVA Diagnostics are pleased to announce 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 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.

Initial studies by Hasselt University 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 University 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. 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.⁽¹⁾

"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 University.

"It was great for VIB to be involved in the discussions between Hasselt University 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.   

About Hasselt University
Hasselt University (Dutch: Universiteit Hasselt, UHasselt) is a university with campuses in Hasselt and Diepenbeek, Belgium. True to its baseline 'Knowledge in action', Hasselt University is an innovative and dynamic university – an institution which provides for a qualified workforce, locally adapted research, appropriate services and technologies for the region. The university has six faculties (Law, Sciences, Business Economics, Medicine & Life Sciences, Architecture & Arts and Engineering Technology) and seven research institutes (which cover a wide range of research areas: biomedical, environmental, statistical, material, transportation research, innovation management research and media technology research). UHasselt is home to about 5,500 students and 1,200 academic, administrative and technical staff members. The university has an extensive international network and develops joint programmes with universities in Flanders and The Netherlands.  Further information about Hasselt University can be found at www.uhasselt.be.

About INOVA Diagnostics, Inc.
INOVA Diagnostics, Inc. is a privately held company headquartered in San Diego, California, which was acquired by Werfen Group in 2008. Werfen Group's in vitro diagnostics  division also includes Instrumentation Laboratory and Biokit, and is committed to improving the quality and efficiency of diagnostic testing in specialty markets like Autoimmunity, Hemostasis, Critical Care and Infectious Diseases.  INOVA Diagnostics is the global leader in the development and commercialization of innovative diagnostic systems and tests for autoimmune disease that are used in clinical laboratories and hospitals around the world.   Further information about INOVA Diagnostics can be found at www.inovadx.com.

References:
⁽¹⁾ Somers, V., et. al, Novel autoantibody markers for early and seronegative rheumatoid arthritis, J Autoimmun. 2011 Feb;36(1):33-46. doi: 10.1016/j.jaut.2010.10.003. Epub 2010 Nov 10.