# Biomarker Developmental Laboratory (BDL)

> **NIH NIH U2C** · MASSACHUSETTS GENERAL HOSPITAL · 2022 · $402,579

## Abstract

Project Summary/Abstract – Biomarker Developmental Laboratory
The Biomarker Developmental Laboratory for the proposed BCC will develop and validate genomic and
proteomic assays for the detection of ovarian cancer in uterine lavage samples. The genomic assays will
analyze the cellular pellet from uterine lavage for genome wide hypomethylation. This genome-wide approach
increases the clinical sensitivity of the biospecimen sampling. Machine learning methods will be applied to
optimize the aggregation of the methylation signal across the genome accounting for the unknown fraction of
sample derived from ovarian/fallopian tube cancer cells and the remaining fraction mostly comprised of
uterine epithelial cells. Proteomic analysis of the uterine lavage fluid using proximity extension assays (PEAs)
have a superior analytical sensitivity to mass spectrometry. Analysis of samples from a training cohort of cases
and controls by PEA will identify upregulated proteins from the tumor and its microenvironment. Supervised
biostatistical classifiers will define an optimal panel of up to 21 PEA biomarker proteins. The optimal panel will
undergo Custom Panel development for absolute quantitation under the direction of the BRL (biomarker
reference laboratory). The training samples will be re-assayed, and a classifier developed combining the
custom panel proteins and the aggregated methylation signal to form a combined classifier. The combined
classifier will be tested in uterine lavage samples from an independent validation cohort. If the classifier is
validated, the classifier will be applied to the cervical swabs – same biospecimen as a Pap smear – to
determine its performance in a readily accessible and patient acceptable sample.

## Key facts

- **NIH application ID:** 10485566
- **Project number:** 1U2CCA271871-01
- **Recipient organization:** MASSACHUSETTS GENERAL HOSPITAL
- **Principal Investigator:** Steven J Skates
- **Activity code:** U2C (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $402,579
- **Award type:** 1
- **Project period:** 2022-09-01 → 2027-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10485566

## Citation

> US National Institutes of Health, RePORTER application 10485566, Biomarker Developmental Laboratory (BDL) (1U2CCA271871-01). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10485566. Licensed CC0.

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