# Biomarker Developmental Laboratory

> **NIH NIH U2C** · JOHNS HOPKINS UNIVERSITY · 2022 · $474,966

## Abstract

Project Summary (BDL)
The Biomarker Development Laboratory (BDL) of the proposed BCC is proposed to discover, verify, prioritize,
and validate biomarkers, and then to harness the power of selected multimodal biomarkers in the form of in
vitro diagnostic multivariate index assays (IVDMIAs) for the early detection of high-grade serous ovarian
carcinoma (HGSOC). Our proposed research strategy is guided by the working hypothesis that biomarkers that
are biologically involved in or associated with precursor lesions or early HGSOCs are more likely to be able to
capture HGSOC in women at a stage when cure may still be possible. This BDL proposal will primarily focus
on HGSOC and its precursor, serous tubal intraepithelial carcinoma (STIC), because it is the most common
type of ovarian cancer. This study is unique as we focus on identifying and studying biomarkers directly linked
to early ovarian cancer and precursor tissues. Those early biomarkers are prerequisites for early detection of
ovarian cancer to become a reality using Pap smear-based and blood-based samples. The aims are:
1. Continuation of current biomarker development pipeline
2. De novo biomarker discovery driven by the biology of HGSOC pathogenesis and early development and
 adherence to statistically principled methods.
3. (co-aim with BRL) Translation of discoveries into clinical tests – development of in vitro diagnostic
 multivariate index assays (IVDMIAs).
4. Development and evaluation of the falloposcope to detect HGSOC precursor lesions using BDL identified
biomarkers.
5. Participation in EDRN network research projects.
This proposed BDL, with its focused collections of clinical specimens from high-risk women, innovative
approaches in study design, bioinformatics analysis, pathology support, and technology development,
represents a unique yet highly promising endeavor to discover and validate biomarkers to capture HGSOC at
precursor lesion and/or early curable stages. Our expected results will have significant impact on saving many
women’s lives through early detection followed by surgical interventions.

## Key facts

- **NIH application ID:** 10486410
- **Project number:** 1U2CCA271891-01
- **Recipient organization:** JOHNS HOPKINS UNIVERSITY
- **Principal Investigator:** ZHEN ZHANG
- **Activity code:** U2C (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $474,966
- **Award type:** 1
- **Project period:** 2022-08-01 → 2027-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10486410

## Citation

> US National Institutes of Health, RePORTER application 10486410, Biomarker Developmental Laboratory (1U2CCA271891-01). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10486410. Licensed CC0.

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