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Revision Applications for Validation of Biomarker Assays Developed Through NIH-Supported Research Grants (R01 Clinical Trial Not Allowed)

National Institutes of Health

Through this Notice of Funding Opportunity (NOFO) is to accelerate the pace of translation of NCI-supported methods/assays/technologies (referred to as "assays") to the clinic. Specifically, the focus of this NOFO is on the adaption and clinical validation of molecular/cellular/imaging mar

Funding
Varies
Category
Education
Status
OPEN
Deadline
10/15/2026

About

Through this Notice of Funding Opportunity (NOFO) is to accelerate the pace of translation of NCI-supported methods/assays/technologies (referred to as "assays") to the clinic. Specifically, the focus of this NOFO is on the adaption and clinical validation of molecular/cellular/imaging markers (referred to as "markers" r "biomarkers") for cancer detection, diagnosis, prognosis, monitoring, and prediction of response in treatment, as well as markers for cancer control and prevention. Research applications may support the acquisition of well-annotated specimens from NCI-supported or other clinical trials or observational cohorts/consortia for the purpose of clinical validation of the assay. Research projects proposed for this NOFO encourage multi-disciplinary interaction among scientific investigators, assay developers, clinicians, statisticians, and clinical laboratory staff. Clinical laboratory scientist(s) and statistical experts are highly encouraged to comprise integral parts of the application. This NOFO is not intended to support early-stage development of technology or the conduct of clinical trials, but rather the adaption and validation of assays to the point where they could be integrated into clinical trials as investigational assays/tools/devices.

Eligibility

Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession.

Applicant types

Grants.gov eligibility code 00Grants.gov eligibility code 01Grants.gov eligibility code 02Grants.gov eligibility code 04Grants.gov eligibility code 05Grants.gov eligibility code 06Grants.gov eligibility code 07Grants.gov eligibility code 08Grants.gov eligibility code 11Grants.gov eligibility code 12Grants.gov eligibility code 13Grants.gov eligibility code 20Grants.gov eligibility code 22Grants.gov eligibility code 23Grants.gov eligibility code 25
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Notice-specific evidence check

What an applicant must verify for Revision Applications for Validation of Biomarker Assays Developed Through NIH-Supported Research Grants (R01 Clinical Trial Not Allowed)

Applicant evidence

  • Applicant type: State governments
  • Applicant type: County governments
  • Applicant type: City or township governments
  • Applicant type: Special district governments
  • Applicant type: Independent school districts
  • Applicant type: Public and state-controlled institutions of higher education
  • Applicant type: Federally recognized tribal governments
  • Applicant type: Public housing authorities and Indian housing authorities

Opportunity boundaries

  • Recorded deadline: October 15, 2026; confirm time zone and submission system.
  • Recorded focus: Education
  • Recorded focus: Health
Do not infer missing fields: award amount. Absence from this directory record is not evidence that a restriction does not exist.
Before investing in an application, connect every eligibility claim, required registration, submission component and deadline to the current official notice. Open the recorded official source →

Application checklist

How to apply for Revision Applications for Validation of Biomarker Assays Developed Through NIH-Supported Research Grants (R01 Clinical Trial Not Allowed)

The steps below turn the recorded grant fields into a pre-submission check. They do not replace the current Notice of Funding Opportunity or its amendments.

Recorded eligibility

  • • Applicant types: Grants.gov eligibility code 00, Grants.gov eligibility code 01, Grants.gov eligibility code 02, Grants.gov eligibility code 04, Grants.gov eligibility code 05, Grants.gov eligibility code 06.
  • • Geographic scope is not structured in this record.
  • • Notice summary: Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession.

Focus areas: ED, HL

Recorded deadline

October 14, 2026 — confirm the time zone and submission system

A missing or rolling date is not permission to assume an open application window.

  1. 1. Confirm fitMatch your applicant type, location, project scope and any cost-share or registration rule to the official notice.
  2. 2. Read the noticeCollect the current guidelines, amendments, budget rules, required attachments and submission instructions.
  3. 3. Check timingRecord the deadline time zone, internal review date and any earlier registration or portal cut-off.
  4. 4. Submit thereUse the official application route and save the confirmation or submission reference.

Official sources

Recorded source: https://www.grants.gov/xml-extract

Open official notice →

Last directory verification: Sep 13, 2026.