# Multi-modal Liquid Biopsy Early Assessment of Breast Cancer, Pancreatic Cancer, and Multiple Myeloma

> **NIH NIH U01** · UNIVERSITY OF SOUTHERN CALIFORNIA · 2023 · $695,450

## Abstract

Abstract
This Liquid Biopsy Research Laboratory (LBRL) will address specific unmet clinical needs in the early
assessment of cancer by developing and validating multi-analyte liquid biopsy (LBx) technologies in distinct
clinical contexts to maximize patient benefit by bringing together clinical, research, and industry experts. The
LBRL proposed research is motivated by preliminary work published by us and others that indicate tumors leak
detectable levels of multiple analytes, potentially early in tumor evolution, into the circulatory system. Here we
propose three research projects that will address current clinical gaps in the early assessment of cancer using
LBx technologies to maximally leverage resources toward gaining sufficient evidence for clinical implementation
of at least one project by the end of the initial period. Clinical utilities will be explored in both screening and
diagnostic workup in the early assessment of cancer with a focus on refining and validating technologies,
methods, and assays for LBx and a particular emphasis on integrating the genomics and proteomics of single
cells, as well as oncosomes, along with plasma genomics and proteomics to configure a final, clinically impactful
assay. Aim 1 will focus on developing a comprehensive LBx-based companion to mammography for the early
assessment of breast cancer (BC) with a focus on the `intent to treat' population of patients undergoing screening.
Subaims include technology refinement for (1) a fit for purpose test consisting of previously validated
immunofluorescence (IF) assays to characterize rare epithelial, endothelial, mesenchymal, and immune cells as
well as oncosomes; and (2) existing comprehensive tests adapted for the requirements of low disease burden
using multi-omic, multi-analyte approach for diagnostic workup following a positive mammogram or following a
positive LBx screening test. Aim 2 will focus on developing enhanced screening and diagnostic workup for
pancreatic cancer (PANC) through multi-omic capabilities on cells and plasma to create a multi-modal LBx aimed
at a fit for purpose test appropriate as a screening tool prior to diagnostic imaging or an information-rich adjunct
to an EUS procedure. Aim 3 is focused on the development of a PB LBx as a substitute to bone marrow aspirate
(BMA) to diagnosed myeloma precursor states (MGUS and SMM) and detect the transition to multiple myeloma
to easily identify candidates for early treatment intervention. The overall partnership team of the LBRL is
leveraging established collaborations with a track record of identifying the clinical gap, designing studies that
have a high likelihood of timely recruitment of patients and successful procurement of samples, technological
innovation and refinement, compliant and scalable commercial solution development, and deployment into
clinical care.

## Key facts

- **NIH application ID:** 10763336
- **Project number:** 1U01CA285013-01
- **Recipient organization:** UNIVERSITY OF SOUTHERN CALIFORNIA
- **Principal Investigator:** PETER KUHN
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2023
- **Award amount:** $695,450
- **Award type:** 1
- **Project period:** 2023-09-18 → 2028-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10763336

## Citation

> US National Institutes of Health, RePORTER application 10763336, Multi-modal Liquid Biopsy Early Assessment of Breast Cancer, Pancreatic Cancer, and Multiple Myeloma (1U01CA285013-01). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10763336. Licensed CC0.

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