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

> **NIH NIH R41** · MDDX, INC. · 2021 · $399,972

## Abstract

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 <20 biomarkers can differentiate between women: 1. with
and without cancer with accuracies of ~90% or higher (area under receiver operating curve, AUROC=0.92), 2.
with OvCA vs EndoCA (AUROC=0.97), and 3. type I vs II EndoCA subtypes. This current approach requires
that each patient is screened using the 21,000 protein array, which while powerful, would be prohibitively
expensive and inefficient, and complicates the process of assigning a risk score; however, our data indicates
that there is a minimum and common set of ~100 biomarkers that could be used for screening all women.
This STTR program aims to refine our current platform into an affordable, easy-to-use, high confidence
biomarker panel that can be used to screen all perimenopausal and older women as well as those with
known risk factors for these two cancers. The goal of this Phase I STTR proposal is to select the optimized
set of AAbs required to assign a high specificity risk score and perform preliminary validation of this diagnostic
panel. In Aim 1 we will expand our proprietary database of plasma autoantibodies to ensure that we have a
sample size (~650) that will enable us to confidently apply our machine learning approaches to identifying the
minimal panel of AAbs for the diagnostic. We will use this enhanced database to identify a prototype panel of
~200 AAbs for construction of classification scoring functions to distinguish between cancer and no cancer, as
well as OvCA vs. EndoCA, and type I vs II EndoCA. In Aim 2 we will perform a blinded validation and
performance study using an independent set of 200 biobanked blood samples of women with and without
these cancers to identify the minimal panel of ~100 biomarkers for large scale prospective validation in Phase
II. Successful completion of this Phase I program will identify the optimized pan...

## Key facts

- **NIH application ID:** 10139681
- **Project number:** 1R41CA257115-01
- **Recipient organization:** MDDX, INC.
- **Principal Investigator:** JOHN A MARTIGNETTI
- **Activity code:** R41 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $399,972
- **Award type:** 1
- **Project period:** 2021-09-01 → 2023-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10139681

## Citation

> US National Institutes of Health, RePORTER application 10139681, Development of a biomarker panel for screening and early detection of gynecological cancers (1R41CA257115-01). Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/grant/nih/10139681. Licensed CC0.

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