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Development of a Molecular Assay to Diagnose Malignant Pleural Effusions

Award Number: R44CA287829
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 02/01/2025
PERIOD OF PERFORMANCE END DATE: 07/31/2026

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Development of a Molecular Assay to Diagnose Malignant Pleural Effusions - This application is being submitted in response to NOSI NOT-CA-24-050 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 indeterminate pleural effusion patients. 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.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = $70,000 )
2025	2025	PRECISION EPIGENOMICS INC.	630 N ALVERNON WAY STE 280B	TUCSON	AZ	85711	PIMA	USA	Cancer Detection and Diagnosis Research	000	1	3/3/2025	SUPPLEMENT FOR EXPANSION	$70,000
														Subtotal = $70,000

Issue Date FY: 2024 ( Subtotal = $1,004,107 )
2024	2024	PRECISION EPIGENOMICS INC.	9040 SOUTH RITA ROAD	TUCSON	AZ	85747	PIMA	USA	Cancer Detection and Diagnosis Research	000	1	7/24/2024	NEW	$1,004,107
														Subtotal = $1,004,107

Grand Total All Awards = $1,074,107

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Development of a Molecular Assay to Diagnose Malignant Pleural Effusions

Award Number: R44CA287829

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 02/01/2025

PERIOD OF PERFORMANCE END DATE: 07/31/2026

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