# Biomarker Reference Laboratory (BRL)

> **NIH NIH U2C** · MASSACHUSETTS GENERAL HOSPITAL · 2022 · $200,997

## Abstract

Project Summary/Abstract – Biomarker Reference Laboratory
The proposed BCC will develop sensitive genomic and proteomic tests for the early detection of ovarian cancer
in uterine lavage samples. The genomic component will assess genome-wide methylation, and the proteomic
component will assay proteins using the proximity extension assays (PEAs) which provide relative quantitation
between samples. The test will be optimized on samples from a training cohort. The methylation signal will be
aggregated and optimized across the genome using machine learning approaches by the biomarker
developmental lab (BDL). Optimization of the proteomic component will identify a custom panel of up to 21
proteins for absolute quantitation. The Biomarker Reference Laboratory (BRL) will work with Fulgent Genetics
to ensure that optimized methylation signal and the custom panel of protein assays comply with CLIA/CAP
standards and achieve analytical performance metrics specified by the BRL. The PI of BRL has extensive
experience in ensuring assays in her clinical biochemistry lab serving the University Health Network, the
largest in Canada, achieve clinical grade before analysis of patient samples are implemented in the lab’s
workstream. The BRL will apply similar standards, agreed upon by all investigators in the BCC, to the
methylation aggregated signal, the custom panel, and the classifier formed by combining the methylation
signal with the protein abundances in the custom panel. This test using the classifier combining the genomic
and proteomic signals, qualified with these standards, will give the highest probability of success for a test for
the early detection of ovarian cancer when applied to uterine lavage samples from an independent validation
cohort, and to cervical swabs as a readily accessible biospecimen with high patient acceptability.

## Key facts

- **NIH application ID:** 10485567
- **Project number:** 1U2CCA271871-01
- **Recipient organization:** MASSACHUSETTS GENERAL HOSPITAL
- **Principal Investigator:** Vathany Kulasingam
- **Activity code:** U2C (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $200,997
- **Award type:** 1
- **Project period:** 2022-09-01 → 2027-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10485567

## Citation

> US National Institutes of Health, RePORTER application 10485567, Biomarker Reference Laboratory (BRL) (1U2CCA271871-01). Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/grant/nih/10485567. Licensed CC0.

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