Wisconsin Alumni Research Foundation

Innovative New Diagnostic Test for Sjögren’s Syndrome – 2022 WARF Innovation Awards Nominee

Meet the medical team and statisticians making it less painful to diagnose a debilitating autoimmune disorder.

Sjögren’s syndrome is one of the most common systemic rheumatic diseases, affecting an estimated 4 million Americans. In roughly half of patients, this disorder occurs in the presence of another autoimmune connective tissue disease such as rheumatoid arthritis, lupus or scleroderma. Sjögren’s syndrome can cause significant dysfunction in a variety of organs and systems. It is associated with significant morbidity and an increased risk of lymphoma.

An antibody-focused test is available that, in combination with other clinical indicators, can be used to diagnose Sjögren’s syndrome. However, 30% of Sjögren’s syndrome patients are “seronegative,” meaning they do not carry the antibody. These patients require an invasive, painful inner lip biopsy to diagnosis the disease. Practitioners capable of performing the lip biopsy and specialists able to analyze the results are not readily available.

A team of UW-Madison researchers – Sara McCoy, Miriam Shelef, Michael Newton and Zihao Zheng – have developed a new diagnostic assay for Sjögren’s syndrome based on their discovery of novel autoantibodies that are relevant to progression of the disease. Using whole peptidome array technology, the inventors have identified top candidate novel autoantibodies that can be found in patient serum and used to diagnose patients who are seronegative, replacing the need for a lip biopsy. The method and testing kit may be formatted as an enzyme-linked immunosorbent assay (ELISA).

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