In-depth Investigations
•10 years of investigations identified two “Glycan Biomarkers” for drug response.
•Developed two tests, SETAX™ and SEPEX™, for detecting biomarkers.
•Verified the reliability, reproducibility, sensitivity, and specificity of SETAX™ and SEPEX™ on human ovarian cancer specimens.
•Validated the clinical correlation of SETAX™ and SEPEX™ tests with drug efficacy on retrospective ovarian cancer tumor sections.
Patent and Proprietary Status
Two patents, filed by Knobbe-Marten Intellectual Property Law Firm (http://knobbe.com)
Future Benchmarks
Number 1- To determine the clinical value of SETAX™ and SEPEX™ for predicting drug response in ovarian cancer patients.
Large- Scale analysis of retrospective and prospective samples
Time: 18-24 months
Value: Developing data and creating protocols for PMA application
Number 2 - To produce the results for FDA submission
Clinical studies by screening FDA required number of ovarian cancer patients
Time: 2-3 years (approximatly)
Value: Produce data to support PMA for FDA approval
