Wisconsin Alumni Research Foundation

Diagnostics & Biomarkers
Diagnostics Biomarkers
Innovative New Diagnostic Test for Sjögren’s Syndrome
WARF: P220234US01

Inventors: Sara McCoy, Miriam Shelef, Michael Newton, Zihao Zheng

The Wisconsin Alumni Research Foundation is seeking commercial partners interested in developing a new ELISA-based laboratory test panel for Sjögren’s syndrome, a rheumatic disease that affects 4 million Americans. The tool is based on the discovery of novel autoantibodies that affect how the disease progresses.
Overview
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.
The Invention
UW-Madison researchers 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).
Applications
  • Diagnosis of Sjögren’s syndrome
Key Benefits
  • Diagnostic assay can identify the disease in both seronegative and seropositive patients.
  • Non-invasive, readily available test replaces painful lip biopsy and eliminates need for specialized practitioners and analysts for diagnosis.
  • No validated test currently exists on the market.
Stage of Development
The inventors included serum from eight seropositive and eight seronegative individuals to develop the whole peptidome array, and externally validated it using samples from a National Institutes of Health-funded registry. Of the more than 5.3 million peptides, the researchers were able to identify 12 total peptides that were significant markers of the disease.
Additional Information
For More Information About the Inventors
For current licensing status, please contact Jennifer Gottwald at [javascript protected email address] or 608-960-9854

WARF