SBIR-STTR Award

Development of Non-Invasive Biomarker Discovery and Diagnostics Approach for Bladder Cancer Based on Urine Proteome and Phosphoproteome
Award last edited on: 9/21/2022

Sponsored Program
SBIR
Awarding Agency
NIH : NCI
Total Award Amount
$1,524,999
Award Phase
2
Solicitation Topic Code
394
Principal Investigator
Anton Iliuk

Company Information

Tymora Analytical Operations LLC

1201 Cumberland Avenue
West Lafayette, IN 47906
Location: Single
Congr. District: 04
County: Tippecanoe

Phase I

Contract Number: 1R44CA239845-01A1
Start Date: 9/1/2019    Completed: 8/31/2020
Phase I year
2019
Phase I Amount
$224,999
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.

Public Health Relevance Statement:
PROJECT NARRATIVE Protein phosphorylation relates to the onset and development of many cancer types and a highly efficient technology for phosphorylation analysis is critical for cancer research. This NIH SBIR Fast-Track project will support the effort to develop an innovative protein/phosphoprotein biomarker discovery and detection platform from urine, with particular focus on bladder cancer diagnostics.

NIH Spending Category:
Biotechnology; Cancer; Prevention; Urologic Diseases

Project Terms:
anticancer research; base; Biological Assay; Biological Markers; biomarker discovery; biomarker panel; Blood; cancer biomarkers; Cancer Detection; Cancer Diagnostics; cancer type; Clinical; clinical application; cohort; Collection; cost; Data; Detection; Development; Devices; Diagnostic; Disease; disease diagnosis; Disease Progression; DNA; Early Diagnosis; Enzyme-Linked Immunosorbent Assay; exosome; experimental study; extracellular vesicles; FDA approved; Feasibility Studies; Freezing; In Vitro; innovation; instrument; liquid biopsy; Liquid substance; Malignant neoplasm of urinary bladder; Malignant Neoplasms; Measurable; Methods; MicroRNAs; model development; Monitor; Neoplasm Circulating Cells; Non-Invasive Cancer Detection; novel; Phase; Phosphoproteins; Phosphorylation; Process; Proteins; Proteome; Proteomics; Public Health; Recovery; Reporting; Reproducibility; Research; Sampling; Small Business Innovation Research Grant; Source; Standardization; Statistical Models; Technology; Testing; Time; Tissues; Training; Translating; tumor; tumor DNA; tumor heterogeneity; United States National Institutes of Health; urinary; Urine; Validation; virtual

Phase II

Contract Number: 4R44CA239845-02
Start Date: 9/1/2019    Completed: 8/31/2022
Phase II year
2020
(last award dollars: 2021)
Phase II Amount
$1,300,000

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.

Public Health Relevance Statement:
PROJECT NARRATIVE Protein phosphorylation relates to the onset and development of many cancer types and a highly efficient technology for phosphorylation analysis is critical for cancer research. This NIH SBIR Fast-Track project will support the effort to develop an innovative protein/phosphoprotein biomarker discovery and detection platform from urine, with particular focus on bladder cancer diagnostics.

Project Terms:
anticancer research; base; Biological Assay; Biological Markers; biomarker discovery; biomarker panel; Blood; cancer biomarkers; Cancer Detection; Cancer Diagnostics; cancer type; Clinical; clinical application; cohort; Collection; cost; Data; Detection; Development; Devices; Diagnostic; Disease; disease diagnosis; Disease Progression; DNA; Early Diagnosis; Enzyme-Linked Immunosorbent Assay; exosome; experimental study; extracellular vesicles; FDA approved; Feasibility Studies; Freezing; In Vitro; innovation; instrument; liquid biopsy; Liquid substance; Malignant neoplasm of urinary bladder; Malignant Neoplasms; Measurable; Methods; MicroRNAs; model development; Monitor; Neoplasm Circulating Cells; Non-Invasive Cancer Detection; novel; Phase; Phosphoproteins; Phosphorylation; Process; Proteins; Proteome; Proteomics; Public Health; Recovery; Reporting; Reproducibility; Research; Sampling; Small Business Innovation Research Grant; Source; Standardization; Statistical Models; Technology; Testing; Time; Tissues; Training; Translating; tumor; tumor DNA; tumor heterogeneity; United States National Institutes of Health; urinary; Urine; Validation; virtual