# Core - Biomarker Developmental Laboratory (BDL)

> **NIH NIH U2C** · FRED HUTCHINSON CANCER CENTER · 2024 · $551,928

## Abstract

Project Summary/Abstract (Biomarker Development Laboratory (BDL) Component, RFA-CA-22-040)
 We propose to develop a blood-based test whose indicated use is to complement mammography in the early
detection of breast cancers. Although mammography saves lives through early detection, it is imperfect.
Approximately one in seven breast cancers goes undetected despite screening mammography, and interval
cancers that manifest within a year of a normal mammogram remain a vexing problem, especially (although not
exclusively) for the >27 million women in the United States with heterogeneously or extremely dense breasts at
high risk for interval cancers. We propose to develop a blood test that could be used as an adjunct to
mammography to improve early detection by improving sensitivity and/or specificity of mammography.
 Using a novel biomarker discovery approach leveraging human-in-mouse breast cancer patient-derived
xenograft models and state-of-the-art mass spectrometry methods, we prioritized a subset of 162 candidate
breast cancer protein biomarkers (verified in human plasma from breast cancer cases vs. controls) for follow up
EDRN phase 2 validation studies in this proposed BCC.
 Our project will clinically validate and deploy (in our CLIA laboratories) a novel multiplex immuno-multiple
reaction monitoring mass spectrometry (immuno-MRM-MS) assay to perform EDRN phase 2 biomarker
validation studies using strongly unbiased sets of plasma samples obtained from existing biorepositories.
 The Biomarker Development Laboratory will contribute to the proposed EDRN phase 2 biomarker validation
studies by: (i) following industry guidelines based on Clinical and Laboratory Standards Institute (CLSI) document
C64 to develop qualified reagents and methods for quantifying 162 candidate protein biomarkers of early-stage
breast cancer, (ii) procuring plasma biospecimens (collected using the EDRN PRoBE study design to avoid bias)
for EDRN phase 2 biomarker validation studies, (iii) delivering plasma aliquots to our BRL CLIA labs in a blinded
fashion, and (iv) analyzing EDRN phase 2 validation data generated by the BRL, providing statistical,
epidemiological, and breast imaging expertise to set and evaluate performance metrics to ensure biomarkers
are adequate to provide clinical utility for early detection.

## Key facts

- **NIH application ID:** 10857309
- **Project number:** 5U2CCA271873-02
- **Recipient organization:** FRED HUTCHINSON CANCER CENTER
- **Principal Investigator:** AMANDA G PAULOVICH
- **Activity code:** U2C (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $551,928
- **Award type:** 5
- **Project period:** 2023-06-05 → 2028-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10857309

## Citation

> US National Institutes of Health, RePORTER application 10857309, Core - Biomarker Developmental Laboratory (BDL) (5U2CCA271873-02). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10857309. Licensed CC0.

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