# Development of a Molecular Assay to Diagnose Malignant Pleural Effusions

> **NIH NIH R44** · PRECISION EPIGENOMICS, INC. · 2024 · $1,004,107

## Abstract

Precision Epigenomics Inc, is a University of Arizona Cancer Center and Department of
Pathology, spin out, aiming to launch molecular diagnostic tests for cancer patients. The product
of this SBIR is Sentinel-MPE liquid biopsy assay, which is a multi-cancer detection test. Our
Sentinel-MPE test can identify over twenty different cancer types. Here, we apply the Sentinel-
MPE test to the differential diagnosis of pleural effusions. In clinical practice, it remains a
challenge to distinguish between malignant pleural effusion (MPE) and benign pleural effusion
(BPE). Cytology remains the gold standard for the detection of malignant cells in pleural effusion.
However, its sensitivity is limited. Because of the limitations of conventional cytology methods,
there is an urgent need to develop a more accurate and effective method for the efficient diagnosis
of MPE. In collaboration with the University of Arizona, Precision Epigenomics has generated
significant feasibility and clinical utility data using pleural effusion. Our pilot studies indicate that
our Sentinel-MPE test has the potential to be an effective complimentary tool for cytology in the
process of differential diagnosis. The aim of this project is to conduct a multi-site clinical validation
study to establish the Sentinel-MPE test as a new commercial molecular test for the diagnosis of
MPE. The aims of this project are: 1) To establish the diagnostic value of the Sentinel-MPE liquid
biopsy assay to identify cancer in pleural effusion and 2) To validate the Sentinel-MPE liquid
biopsy assay for cancer detection in pleural effusion. The long-term goal of this project is to bring
the field of pathology a new diagnostic tool for the diagnosis of malignant pleural effusions.

## Key facts

- **NIH application ID:** 11005186
- **Project number:** 1R44CA287829-01A1
- **Recipient organization:** PRECISION EPIGENOMICS, INC.
- **Principal Investigator:** Mark Anthony Nelson
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $1,004,107
- **Award type:** 1
- **Project period:** 2024-08-01 → 2026-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/11005186

## Citation

> US National Institutes of Health, RePORTER application 11005186, Development of a Molecular Assay to Diagnose Malignant Pleural Effusions (1R44CA287829-01A1). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/11005186. Licensed CC0.

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