Revision Applications for Validation of Biomarker Assays Developed Through NIH-Supported Research Grants (R01 Clinical Trial Not Allowed)
Can you apply?
This grant is for researchers seeking federal funding to validate biomarker assays previously developed with NIH support. Eligible applicants include research institutions, universities, and biomedical research organizations with appropriate R&D infrastructure. This program specifically excludes clinical trial applications (R01 mechanism). Applicants must demonstrate prior NIH-supported research that resulted in a preliminary biomarker assay. The project must focus on validation work such as analytical and clinical performance testing.
Funded research typically occurs at academic medical centers, independent research institutes, and biotech organizations. International institutions may apply if they meet NIH requirements. Validation studies must use rigorous, standardized protocols. Projects should build directly on previously funded NIH work.
This grant is for researchers seeking federal funding to validate biomarker assays previously developed with NIH support. Eligible applicants include research institutions, universities, and biomedical research organizations with appropriate R&D infrastructure. This program specifically excludes clinical trial applications (R01 mechanism). Applicants must demonstrate prior NIH-supported research that resulted in a preliminary biomarker assay. The project must focus on validation work such as analytical and clinical performance testing.
Funded research typically occurs at academic medical centers, independent research institutes, and biotech organizations. International institutions may apply if they meet NIH requirements. Validation studies must use rigorous, standardized protocols. Projects should build directly on previously funded NIH work.
Program description
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.
Who can apply
Eligible applicants
- 501(c)(3) Public Charity
- City / Municipal Government
- County Government
- Nonprofits
- Private University
- Public Authority
- Public K-12 School
- Public University
- Small Business (SBA-defined)
- Special District
- State Government
- Tribal Nation
- Tribal Organization
Details
This grant is for researchers seeking federal funding to validate biomarker assays previously developed with NIH support. Eligible applicants include research institutions, universities, and biomedical research organizations with appropriate R&D infrastructure. This program specifically excludes clinical trial applications (R01 mechanism). Applicants must demonstrate prior NIH-supported research that resulted in a preliminary biomarker assay. The project must focus on validation work such as analytical and clinical performance testing.
Funded research typically occurs at academic medical centers, independent research institutes, and biotech organizations. International institutions may apply if they meet NIH requirements. Validation studies must use rigorous, standardized protocols. Projects should build directly on previously funded NIH work.
How to apply
Application links
Required documents
- NIH SF-424 (R&R) application form
- Project Narrative (aims, significance, innovation)
- Research Strategy (specific aims, background, methods, timeline)
- Budget and Budget Justification
- Biographical Sketches of key personnel
- Letters of Support or Institutional Endorsement
- Prior NIH Grant Documentation (original R01 or supporting research grant)
- Preliminary Data and Publication List
Program contact
- 👤 National Institutes of Health
- 📧 grantsinfo@nih.gov
- 📞 301-402-2541
Funding track record
Recent awards under CFDA 93.394 from the last 3 years — real organizations that won funding through this same program.
Top 10 Largest Recent Awards
-
$67,679,289
-
$42,479,238
-
$38,139,324
-
$37,524,148
-
$36,939,788
-
$35,037,695
-
$30,393,940
-
$30,179,102
-
$18,143,614
-
$16,667,828
Top States by Funding
- PA 9 awards $127.6M
- WA 5 awards $103.0M
- CA 11 awards $101.7M
- TX 8 awards $91.8M
- OH 5 awards $73.1M
Source: USAspending.gov — federal spending transparency. Data covers last 3 years.
Funding history
Annual funding for this program — Federal obligations (CFDA 93.394). How funding has trended year over year.
| 2024 | $540,918,671 | |
| 2025 | $602,293,691 | |
| 2026 est. | $716,748,079 |
FAQ
Who can apply for this grant?
Research institutions, universities, and nonprofit research organizations with established research infrastructure. For-profit entities may also be eligible. Prior NIH funding for the biomarker development is required.
What is the deadline?
October 14, 2026. Applications open October 10, 2024. Use the NIH Commons to submit by 11:59 p.m. ET on the deadline date.
What types of research are supported?
Analytical and clinical validation of previously developed biomarker assays. Methodology refinement, performance testing, and clinical utility studies are included. Clinical trials are NOT allowed under this mechanism.
Is this grant competitive?
Yes, very competitive. NIH biomarker validation grants require strong preliminary data and rigorous study designs. Clear connections to prior NIH-supported work strengthen applications.
What funding amounts are typical?
Most NIH R01-level revision grants range from $200,000 to $500,000 in direct costs per year. Actual amounts vary based on project scope and agency guidance.
💡 Tips for applicants
- Link your proposed validation work directly to the original NIH-supported biomarker development. Show clear continuity and evolution of the research.
- Use rigorous, well-established assay validation protocols. Describe analytical validation (accuracy, precision, reproducibility) and clinical validation plans in detail.
- Include preliminary data demonstrating the biomarker's potential clinical utility. Weak preliminary data is a common reason for rejection.
- Address the regulatory pathway for your biomarker if applicable (FDA clearance, lab-developed test standards). Show you understand translation requirements.
- Budget conservatively and justify personnel, equipment, and validation study costs clearly. Overestimation of costs weakens competitiveness.
⚠️ Common mistakes
Weak preliminary data or insufficient evidence that the biomarker shows clinical promise. Inadequate study design for validation work; insufficient rigor in statistical analysis. Failing to demonstrate clear continuity with prior NIH-supported research that developed the assay.
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