Oxford Gene Technology (OGT) has announced the development of a novel autoantibody biomarker panel for improved diagnosis of systemic lupus erythematosus (SLE).
The panel has been developed in partnership with King’s College London, utilising OGT’s proprietary protein array platform technology. The platform detects autoantibodies, a class of proteins that have been shown to precede clinical symptoms of SLE by several years1. It also accurately distinguishes between SLE and ‘confounding diseases’ such as rheumatoid arthritis.
The biomarker panel, which was originally identified using a North American sample cohort, has been rigorously validated in two independent sample cohorts comprising over 450 European, Afro-Caribbean, and confounding disease samples. The panel maintains a high sensitivity and specificity across all cohorts studied.
SLE affects at least five million people worldwide, over 90% of whom are women. The figure may be higher as SLE is notoriously challenging to diagnose with widely variable symptoms which are inconsistent in patients. Current diagnosis is usually performed by comparing a patient’s symptoms against 11 pre-set criteria established by the American College of Rheumatology. If the patient presents any four of the symptoms simultaneously or serially on two separate occasions, they are classified as having SLE. Typically it takes several years and the involvement of many clinicians to diagnose an SLE patient.
Existing laboratory tests include antinuclear antibody (ANA) testing and anti-double stranded DNA (anti-dsDNA) testing but their specificity or sensitivity is too low to support the diagnosis or classification of SLE without additional data. The OGT panel would allow for earlier and more accurate diagnosis than existing tests addressing a clear unmet medical need.
Dr Mike Evans, CEO at OGT said, “SLE is a truly debilitating disease that is particularly challenging to diagnose. Our novel diagnostic biomarker panel is more sensitive and specific than existing laboratory tests and it is our hope that, by correctly identifying the presence of SLE at an earlier stage, patients will receive faster access to the most appropriate treatment. We are pleased with the progress of our biomarker portfolio, which also includes advanced programmes in prostate and colorectal cancer, and we are currently evaluating potential partners to develop diagnostic tests based on the SLE biomarkers.”
Professor Tim Vyse, Division of Genetics and Molecular Medicine at King’s College London said: “The OGT SLE panel represents a big step forward in lupus genetic testing and the outcome of the programme so far has been very encouraging.”
OGT is also in discussions with SLE drug developers regarding potential prognostic applications of the biomarkers set to predict the occurrence and frequency of relapse, or ‘flares’, so that treatment regimens can be adjusted accordingly and patient well-being maximised.