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Development of non-invasive biomarker discovery and diagnostics approach for bladder cancer based on urine proteome and phosphoproteome

Award Number: R44CA239845
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/01/2019
PERIOD OF PERFORMANCE END DATE: 08/31/2023

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Development of non-invasive biomarker discovery and diagnostics approach for bladder cancer based on urine proteome and phosphoproteome - PROJECT SUMMARY Profiling of Extracellular Vesicles (EV) has emerged as a highly promising field for discovery of tumor-relevant biomarkers from biofluids, such as blood, urine, CSF or others. The use of biofluid EVs offers numerous advantages in clinical setting, including non-invasive collection, a suitable sample source for longitudinal disease monitoring, better screenshot of tumor heterogeneity, higher stability and sample volumes, faster processing times, lower rejection rates and costs compared to their tissue counterpart. Despite the immense potential, the data on EV phosphoproteomes are virtually non-existent. In this NIH SBIR Fast-Track study, we will further develop a novel urine analysis platform based on EVtrap beads for complete capture of extracellular vesicles and in-house developed proteome extraction and analysis approach into highly efficient and reproducible method for discovery and detection of cancer biomarkers. We have already utilized this approach to generate a new panel of protein/phosphoprotein markers from urinary EVs for sensitive and non-invasive detection and monitoring of bladder cancer. During this project, the discovered biomarkers panel will be validated and refined to demonstrate clinical utility. The following aims will be completed in the Phase I of the proposal: Aim #1: Develop and optimize EVtrap for large-scale and high-throughput EV isolation. Aim #2: Determine the feasibility of the current bladder cancer biomarkers and refine the panel. The following aims will be completed in the Phase II of the proposal: Aim #1: Adapt EVtrap to an existing automated device for high-throughput EV capture and cargo analysis. Aim #2: Validate and standardize the final panel for clinical utility. By the completion of this project, a biomarker discovery platform from urine will be developed, and bladder cancer monitoring assay will be validated that can overcome the limitations of current approaches, and thus could have an enormous public health impact and market potential.


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: 2024 ( Subtotal = $0 )
2024	2021	TYMORA ANALYTICAL OPERATIONS LLC	1201 CUMBERLAND AVE	WEST LAFAYETTE	IN	47906	TIPPECANOE	USA	Cancer Detection and Diagnosis Research	000	3	2/12/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2021 ( Subtotal = $700,000 )
2021	2021	TYMORA ANALYTICAL OPERATIONS, LLC	1201 CUMBERLAND AVE STE 209	WEST LAFAYETTE	IN	47906	TIPPECANOE	USA	Cancer Detection and Diagnosis Research	001	3	8/11/2021	NON-COMPETING CONTINUATION	$700,000
2021	2019	TYMORA ANALYTICAL OPERATIONS, LLC	1201 CUMBERLAND AVE STE 209	WEST LAFAYETTE	IN	47906	TIPPECANOE	USA	Cancer Detection and Diagnosis Research	000	1	10/23/2020	NEW	$0
														Subtotal = $700,000

Issue Date FY: 2020 ( Subtotal = $600,000 )
2020	2020	TYMORA ANALYTICAL OPERATIONS, LLC	1201 CUMBERLAND AVE STE 209	WEST LAFAYETTE	IN	47906	TIPPECANOE	USA	Cancer Detection and Diagnosis Research	000	2	9/14/2020	EXTENSION WITH OR WITHOUT FUNDS	$600,000
														Subtotal = $600,000

Issue Date FY: 2019 ( Subtotal = $224,999 )
2019	2019	TYMORA ANALYTICAL OPERATIONS, LLC	1201 CUMBERLAND AVE STE 209	WEST LAFAYETTE	IN	47906	TIPPECANOE	USA	Cancer Detection and Diagnosis Research	000	1	8/30/2019	NEW	$224,999
														Subtotal = $224,999

Grand Total All Awards = $1,524,999

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Development of non-invasive biomarker discovery and diagnostics approach for bladder cancer based on urine proteome and phosphoproteome

Award Number: R44CA239845

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 09/01/2019

PERIOD OF PERFORMANCE END DATE: 08/31/2023

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