Sarcoidosis and TB Biomarkers
WSU Tech#: 15-1276
Technology Summary:
This technology includes a new method for generating phage libraries and clones that are useful in discovering biomarkers from human blood samples. The inventors looked at the change in immune cells versus that of the infected tissue (BAL and blood) used this to generate biomarkers for Sarcoidosis and TB.
A total of 115 sarcoid sera, 64 healthy control sera and 17 TB sera were tested on the 1152 phage peptide microarray. Bioinformatically analyzed data identified 259 antigens with the highest level of differentiation between sarcoidosis and healthy controls. Have identified 32 biomarkers with the sensitivity of 89% and specificity of 83% to classify sarcoidosis from healthy controls. Generating a high-throughput screening method for this technology without the need for extensive and expensive imaging; though, it is not yet optimized.
Competitive Advantages
There is currently no blood or BAL based test for the positive identification of sarcoidosis. This is a novel diagnostic in this regard.
Benefit Analysis:
About 150,000 diagnosed sarcoidosis patients in the U.S., of which approximately 90% have some degree of pulmonary involvement. The incidence is considerably higher for African Americans, at 34 cases per 100,000 population; and seem to experience more severe and chronic disease. The male-to-female ratio for sarcoidosis is approximately 1:2.
Currently screening blood from latent TB patients to develop a diagnostic t diagnose latent tuberculosis infection (LTBI), which is important for the overall control of the disease. Offering anti-tuberculous treatment to individuals with LTBI significantly decreases their risk of developing active tuberculosis. Sensitivity of TB skin test (TST) may yield false positive in people with prior bacille Calmette-guerin vaccine or exposure to non-TB mycobacteria.
Stage of Development: Pre-Clinical
Work is progressing to optimize the diagnostic by developing an interpretive rule that would increase the sensitivity and specificity of the assay; as it is currently not optimized. Also working on enhancing the current diagnostic to detect latent TB.
Patent Status:
Through the Office of Technology Commercialization at Wayne State University, we have filed an extensive and detailed patent application to the USPTO office. This is a detailed methods and composition of matter application with both specific and fairly broad claims. The filing contains a full list of relevant biomarkers and diagnostic methods; which will provide a strong intellectual property position.
Licensing Opportunity:
WSU is looking for a commercial partners interested in furthering the validation of this technology and bringing the technology to market. The inventors would be open to assist in the generation of SBIR/STTR grants to fund the further development of this technology.