Grant Details

General Overview

Grant Information

Grant name: Assay Validation of High Quality Markers for Clinical Studies in Cancer

Funding organization: National Institutes of Health (NIH), National Cancer Institute (NCI)

Total funding amount: $250,000 per year

Duration: Maximum of 3 years

Primary objective: Validate biomarkers and assays for cancer detection, diagnosis, and treatment response prediction

Key stakeholders: Scientific investigators, oncologists, statisticians, clinical laboratory scientists

Funding source: Federal government

Funding type: Cooperative agreement

Significance: Supports clinical validation of assays critical for cancer studies

Grant frequency: Recurring

Organizational Aspects

Eligibility Criteria

Eligible organization types: Higher Education Institutions, Nonprofits, For-Profit Organizations, Local Governments, State Governments, County Governments, City or Township Governments, Indian/Native American Tribal Governments, Federal Agencies, Public Housing Authorities, Faith-based Organizations, Regional Organizations

Specific qualifications: Assays must be analytically validated

Geographic location: U.S. organizations only; foreign organizations are not eligible

Previous relationship with funder: Not specified

Organizational maturity: Not specified

Scope and Focus

Project Characteristics

Primary focus areas: Cancer detection, diagnosis, prognosis, monitoring, treatment response prediction

Target beneficiaries: Cancer patients, clinical researchers

Geographic coverage: U.S.

Expected outcomes: Clinical validation of assays, harmonization of clinical laboratory tests

Sustainability expectations: Not specified

Technical Details

Technical Requirements

Technical expertise: Must include clinical investigators, laboratory staff, and statisticians

Infrastructure: CLIA-certified laboratories preferred for assays supporting medical decision-making

Quality standards: Assays must meet GLP or ISO 17025 standards

Risk management: Not specified

Financial Structure

Budget Information

Direct costs limited to $250,000 per year

Maximum project period: 3 years

Cost sharing: Not required

Timeline and Implementation

Key Dates

Open date: January 14, 2025

Application due dates: Multiple deadlines until October 14, 2026

Earliest start date: February 14, 2025

Compliance and Requirements

Regulatory Compliance

Compliance with NIH Grants Policy Statement required

Required registrations: SAM, eRA Commons, Grants.gov

Application Process

Submission Guidelines

Applications must be submitted electronically via Grants.gov

Follow instructions in the How to Apply - Application Guide

No paper applications accepted

Special Considerations

Unique Aspects

Applications must not propose clinical trials

Focus on validation of existing assays, not early-stage development

Grant Details

cancer biomarkers clinical trials healthcare research medical diagnostics clinical validation assays oncology NCI
Assay Validation of High Quality Markers for Clinical Studies in Cancer
PAR-25-075
NIH Grants
EDU NGO ENTERPRISE PUBLIC RESEARCH OTHER
US
HEALTHCARE OTHER
DEVELOPMENT
OTHER
SDG3
FUNDING RESEARCH_DEVELOPMENT
None
250000.00
250000.00
250000.00
USD
100.00
Oct. 14, 2026, 10 p.m.
March 2025 - July 2027