Revision Applications for Validation of Biomarker Assays Developed Through NIH-Supported Research Grants (R01 Clinical Trial Not Allowed)
ID: 356680Type: Posted
Overview

Buyer

National Institutes of Health (HHS-NIH11)

Eligible Applicants

Others

Funding Category

Health

Funding Instrument

Grant

Opportunity Category

Discretionary

Cost Sharing or Matching Requirement

Yes
Timeline
    Description

    The National Institutes of Health (NIH) has announced a funding opportunity titled "Revision Applications for Validation of Biomarker Assays Developed Through NIH-Supported Research Grants," aimed at accelerating the clinical validation of biomarker assays for cancer detection, diagnosis, prognosis, and treatment response. This initiative encourages multidisciplinary collaboration among researchers, clinicians, and statisticians, focusing on assays that have nearly completed analytical validation and utilize human specimens. The funding amount is capped at $150,000 per year for a maximum duration of three years, with application deadlines starting from January 14, 2025, and concluding on October 15, 2026. Interested applicants can find more information and guidelines at the NIH Grants website or contact NIH Grants Information at grantsinfo@nih.gov for further inquiries.

    Point(s) of Contact
    Files
    Title
    Posted
    The National Cancer Institute (NCI) of the Department of Health and Human Services has issued a Notice of Funding Opportunity (NOFO) encouraging revision applications for the clinical validation of biomarker assays developed under existing NIH-supported research projects. The purpose is to accelerate the translation of molecular, cellular, and imaging markers for cancer detection, diagnosis, prognosis, and treatment response into clinical settings. Applicants are required to have assays with near-completed analytical validation and a focus on using human specimens. The funding opportunity emphasizes multidisciplinary collaboration among researchers, clinicians, and statisticians, with a budget limit of $150,000 per year over a maximum period of three years. Applications must adhere to specific guidelines, with submission deadlines beginning January 14, 2025, and concluding on October 15, 2026. This NOFO aims to facilitate the advancement of biomarker assays, which, despite their promising development stages, often struggle to achieve clinical utility due to inadequate validation processes. The initiative reflects a strategic approach of the NIH to bridge the gap between research and practical clinical applications for cancer patients.
    Similar Opportunities
    Revision Applications for Validation of Biomarker Assays Developed Through NIH-Supported Research Grants (R01 Clinical Trial Not Allowed)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) has announced a Notice of Funding Opportunity (NOFO) for revision applications aimed at validating biomarker assays developed through NIH-supported research grants, specifically under the R01 mechanism, with a focus on enhancing their clinical application for cancer detection and treatment. This initiative seeks to accelerate the translation of molecular, cellular, and imaging markers into clinical settings, encouraging multidisciplinary collaborations among scientists, clinicians, and laboratory experts to adapt and validate these biomarkers for various cancer-related purposes. Eligible applicants include a wide range of organizations such as higher education institutions, nonprofits, and tribal governments, with funding available up to $150,000 for a project period of up to three years. Interested parties should note that the application deadline is October 13, 2026, and can find further details and guidelines at the NIH grants website or contact NIH Grants Information at grantsinfo@nih.gov.
    Assay Validation of High Quality Markers for Clinical Studies in Cancer (UH3 Clinical Trials Not Allowed)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) is offering a funding opportunity titled "Assay Validation of High Quality Markers for Clinical Studies in Cancer," aimed at enhancing the validation and adoption of biomarkers and assays critical for cancer detection, diagnosis, and treatment response prediction. This initiative seeks projects that utilize established assays with demonstrated analytical validation for clinical use, fostering collaboration among scientific experts to address significant gaps in cancer research. The funding amount is capped at $250,000 per year for a project duration of up to three years, with applications due by October 14, 2026. Interested applicants can find more information and application details at the NIH Grants website or contact NIH Grants Information at grantsinfo@nih.gov.
    Assay Validation of High Quality Markers for Clinical Studies in Cancer (UH2/UH3 Clinical Trial Not Allowed)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) is offering a funding opportunity titled "Assay Validation of High Quality Markers for Clinical Studies in Cancer" through a cooperative agreement mechanism (UH2/UH3). This initiative aims to support the validation of molecular, cellular, and imaging biomarkers essential for cancer detection, diagnosis, prognosis, and treatment response monitoring, with a focus on both analytical and clinical validation phases. The funding is intended for projects that demonstrate a working assay on human samples and justify its clinical relevance, fostering multi-disciplinary collaborations among scientific investigators, oncologists, and clinical laboratory scientists. Interested applicants should note that the application deadline is October 14, 2026, and can reach out to NIH Grants Information at grantsinfo@nih.gov for further inquiries. More details can be found at the provided link: https://grants.nih.gov/grants/guide/pa-files/PAR-25-074.html.
    Assay Validation of High Quality Markers for Clinical Studies in Cancer (UH3 Clinical Trials Not Allowed)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) has announced a funding opportunity titled "Assay Validation of High Quality Markers for Clinical Studies in Cancer," aimed at facilitating the clinical validation of biomarkers and assays for cancer management through a Cooperative Agreement mechanism. This initiative seeks to support projects that optimize and validate existing assays for cancer detection, diagnosis, and treatment response evaluation, emphasizing collaboration among multidisciplinary teams of scientific investigators, oncologists, and clinical laboratory scientists. With a maximum funding amount of $250,000 per year available until the application deadline of October 14, 2026, interested applicants are encouraged to demonstrate prior analytical validation of their assays and provide a comprehensive plan for further optimization and integration into clinical studies. For more information, applicants can contact NIH Grants Information at grantsinfo@nih.gov or visit the opportunity's webpage at https://grants.nih.gov/grants/guide/pa-files/PAR-23-314.html.
    Assay Validation of High Quality Markers for Clinical Studies in Cancer (UH2/UH3 Clinical Trial Not Allowed)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) is offering a funding opportunity titled "Assay Validation of High Quality Markers for Clinical Studies in Cancer," aimed at supporting the validation of molecular, cellular, and imaging markers for cancer detection, diagnosis, and treatment. This initiative encompasses a two-phase cooperative agreement mechanism: the UH2 phase focuses on analytical validation of assays over a two-year period, while the UH3 phase supports clinical validation for up to three years, utilizing well-annotated biospecimens from clinical trials. The program emphasizes the importance of multidisciplinary collaboration to enhance the development of assays that can significantly improve cancer research and patient care. Eligible applicants include various institutions and organizations, with a funding ceiling of $275,000 for the UH2 phase and up to $250,000 per year for the UH3 phase. Applications will be accepted starting January 19, 2024, with a final submission deadline of October 15, 2026. For further inquiries, interested parties can contact NIH Grants Information at grantsinfo@nih.gov.
    Integrating Biospecimen Science Approaches into Clinical Assay Development (U01 Clinical Trial Not Allowed)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH), through the National Cancer Institute (NCI), has announced a funding opportunity titled "Integrating Biospecimen Science Approaches into Clinical Assay Development" (FON: PAR-25-325). This initiative aims to support extramural research focused on addressing preanalytical variability in the development and analytical validation of clinical assays utilizing biospecimens such as tumor biopsies and liquid biopsies. The program seeks to enhance the reliability of biomarker assays by investigating how various collection, processing, and storage conditions impact biomarker quantification, ultimately contributing to improved cancer diagnostics and treatment in precision medicine. Interested applicants can apply for funding of up to $250,000 annually for a period of five years, with the first application deadline set for January 4, 2025. For further inquiries, applicants may contact NIH Grants Information at grantsinfo@nih.gov or visit the additional information link at https://grants.nih.gov/grants/guide/pa-files/PAR-25-325.html.
    Innovative Biospecimen Science Technologies for Basic and Clinical Cancer Research (R61 Clinical Trial Not Allowed)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) is inviting grant applications for the opportunity titled "Innovative Biospecimen Science Technologies for Basic and Clinical Cancer Research (R61 Clinical Trial Not Allowed)." This funding initiative aims to support exploratory research projects focused on the early-stage development of innovative technologies that enhance the quality, handling, and preservation of cancer-related biospecimens, addressing issues such as pre-analytical degradation. The initiative is part of the broader Innovative Molecular Analysis Technologies (IMAT) Program and seeks to advance cancer research, early detection, and treatment while addressing health disparities. Eligible applicants include a diverse range of institutions and organizations, with a maximum funding amount of $150,000 per year for up to three years. The application deadline is October 3, 2025, and interested parties can reach out to NIH Grants Information at grantsinfo@nih.gov for further inquiries.
    Clinical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders (U44 Clinical Trial Optional)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) is offering a funding opportunity for the clinical validation of candidate biomarkers for neurological and neuromuscular disorders through the U44 Cooperative Agreement mechanism. This initiative aims to rigorously validate biomarkers that have already been identified and for which detection methods have been developed, ensuring compliance with FDA guidelines to establish their clinical sensitivity and specificity. This program is crucial for advancing therapeutic development in the field of brain health, with funding potentially reaching $700,000 for Phase I and $1.5 million for Phase II projects. Interested applicants must adhere to specific submission guidelines and deadlines, with the application closing on June 22, 2026. For further information, applicants can contact NIH Grants Information at grantsinfo@nih.gov or visit the opportunity's webpage at https://grants.nih.gov/grants/guide/pa-files/PAR-24-096.html.
    Clinical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders (U01 Clinical Trial Optional)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) is offering a funding opportunity titled "Clinical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders (U01 Clinical Trial Optional)." This initiative aims to support the clinical validation of strong candidate biomarkers for neurological and neuromuscular disorders, focusing on establishing their clinical sensitivity and specificity in accordance with FDA guidelines. The program is particularly significant as it seeks to enhance public health outcomes by facilitating the implementation of validated biomarkers in clinical settings, thereby addressing critical healthcare needs in these areas. Interested applicants should note that the application period opens on January 21, 2025, and closes on June 22, 2026. For further inquiries, applicants can contact NIH Grants Information at grantsinfo@nih.gov, and additional details can be found at the provided link: https://grants.nih.gov/grants/guide/pa-files/PAR-25-055.html.
    Advanced Development and Validation of Emerging Biospecimen Science Technologies for Basic and Clinical Cancer Research (R33 Clinical Trial Not Allowed)
    Active
    National Institutes of Health
    The National Institutes of Health (NIH) is offering a funding opportunity titled "Advanced Development and Validation of Emerging Biospecimen Science Technologies for Basic and Clinical Cancer Research (R33 Clinical Trial Not Allowed)." This grant aims to support exploratory research projects that focus on the development and validation of innovative technologies to enhance the quality and handling of cancer-relevant biospecimens, addressing significant gaps in cancer research methodologies. The initiative is part of the National Cancer Institute's (NCI) broader Innovative Molecular Analysis Technologies (IMAT) Program, which seeks to improve cancer biology research, early detection, clinical diagnosis, and treatment, while also tackling health disparities. Eligible applicants can receive up to $300,000 per year for a maximum of three years, with a submission deadline of October 3, 2025. For further inquiries, interested parties can contact NIH Grants Information at grantsinfo@nih.gov or visit the opportunity's webpage at https://grants.nih.gov/grants/guide/rfa-files/RFA-CA-25-004.html.