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Assay Validation of High Quality Markers for Clinical Studies in Cancer (UH2/UH3 Clinical Trial Not Allowed)

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Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

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The Department of Health and Human Services, through the National Cancer Institute, is seeking applications to support the validation of molecular, cellular, and imaging biomarkers and related assays for cancer detection, diagnosis, prognosis, monitoring, treatment response, and prevention. Applicants can submit either a biphasic UH2/UH3 application for up to five years or a standalone UH3 application lasting three years focused on clinical validation. The initial UH2 phase emphasizes analytical validation of assays within two years, after which the UH3 phase supports clinical validation using well-annotated specimens from clinical trials or studies. Biphasic applicants must address milestones that enable progression from analytical to clinical validation, while standalone applicants must already have analytically validated assays suitable for intended clinical uses. The funding also supports validation of pharmacodynamic and toxicity markers, with an emphasis on assays applicable to human samples and clinical settings. Efforts may include harmonizing clinical lab tests and evaluating assay performance across multiple sites. Projects require collaboration among scientists, clinicians, statisticians, and lab specialists, aiming to produce clinically validated assays that enhance cancer risk assessment, precision treatment, and patient management. This opportunity excludes clinical trials but promotes development of assays as tools for cancer research, prevention, and control.

General Info

Funding for validating cancer detection and treatment assays through biphasic or standalone applications.

Agency

Department Of Health And Human Services → National Institutes Of Health

NAICS

541715 - Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology) View NAICS

Place of Performance

Not specified

Set-Aside

NONE

Documents

(0)

No documents available

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Timeline

Posted

forecast

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Organization & Contact Information

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AgencyDepartment Of Health And Human Services → National Institutes Of Health
Contacts1 person available
OfficeUS
Organization / Agency
Department Of Health And Human Services → National Institutes Of Health
Office AddressUS
Contacts
Cancer Diagnosis Program
contact@example.gov
+1 (555) 000-0000

Full Description

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Through this Notice of Funding Opportunity (NOFO), the National Cancer Institute (NCI) solicits applications to support the validation of molecular/cellular/imaging markers (referred to as "markers" or "biomarkers") and assays for cancer detection, diagnosis, prognosis, monitoring, and prediction of response or resistance to treatment, as well as markers for cancer prevention and control. The applicants have the option of submitting either a biphasic UH2/UH3 (Developmental Cooperative Agreement Phase I/Developmental Cooperative Agreement Phase II) application for 5 years or a monophasic standalone UH3 (Developmental Cooperative Agreement Phase II) application for 3 years to support clinical validation of established assays. The UH2 phase of this NOFO will support analytical validation of assays for the markers, which must be achieved within 2 years before assays may undergo clinical validation. The UH3 phase of this NOFO will support clinical validation of analytically validated assays for up to 3 years using well-annotated biospecimens from retrospective or prospective clinical trials or studies. Investigators applying for UH2/UH3 must address both UH2 and UH3 phases, and propose milestones to be accomplished in the UH2 phase for transition to the UH3 phase. Applicants to the stand alone UH3 must have an assay(s) whose performance has been analytically validated in specimens similar to those for the intended use of the assay(s) and marker(s).

This NOFO will also support the validation of pharmacodynamic markers and markers of toxicity. Applicants should have assays that work on human samples and whose importance is well justified for development into clinical assays. As chemotherapies and/or radiation therapies are increasingly combined with immunotherapies to enhance durability of anti-cancer responses, assays for measuring multiple markers, including immune markers, can be developed and validated simultaneously. Investigators applying in response to this NOFO must propose optimizing an existing assay(s) using human specimens in a clinical laboratory into assays that can be used in a clinical trial/study for the treatment, prevention or control of cancer.

This NOFO may be used to validate existing assays for use in other clinical trials, observational studies, or population studies. Efforts to harmonize clinical laboratory tests, including investigation into the performance and Reproducibility of assays across multiple clinical laboratories, are also appropriate for this funding opportunity. Projects proposed for this NOFO will require multidisciplinary interaction and collaboration among scientific investigators, oncologists, statisticians, and clinical laboratory scientists. Clinically validated assays are expected to provide new useful tools for cancer risk/survival assessment, precision cancer prevention and control, for guiding cancer therapy decisions, and for better management of cancer patients.

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