AccuDava, Inc. has been awarded a grant from the National Cancer Institute (NCI), with nearly maximum funding for a Phase I-SBIR (Small Business Innovative Research). This prestigious funding will allow the statistical validation of our “Novel Glyco-tests to Predict Chemoresistance in a large set of Ovarian Cancer Patients”.
AccuDava, Inc. has been selected by the NIH-Innovative Corps (I-Corps) to facilitate the translational path to clinical tests.
- 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)
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 (approx.)
Value: Produce data to support PMA for FDA approval