Development of a biomarker panel for screening and early detection of gynecological cancers

PROJECT SUMMARY It is estimated that more than 80,000 women will be diagnosed with ovarian (OvCA) and endometrial (EndoCA) cancers this year in the U.S. and this will result in the death of 26,000 women.

There are no screening tests for either of these two female-specific cancers which also disproportionally affect ethnically distinct populations.

For both cancers, detection of early stage, localized disease is associated with 5-year survival rates in excess of 90%, while diagnosis with late stage, metastatic disease results in dramatically reduced 5-year survival rates of ~25%.

MDDx, Inc. has been leveraging access to >12-years of longitudinally collected and deeply annotated biobanked plasma samples from the Gynecologic Cancer Translational Research Program (Icahn School of Medicine at Mount Sinai; New York, NY and Nuvance Health; Danbury, CT) to identify tumor-associated autoantibodies (AAb) that could serve as diagnostic biomarkers.

By performing AAb profiling against the entire human proteome and applying our novel machine-learning based method for classification of molecular profiles we have determined that classification signatures of