Opportunity Information: Apply for RFA CA 18 005
The Advanced Development and Validation of Emerging Biospecimen Science Technologies for Basic and Clinical Cancer Research funding opportunity (RFA-CA-18-005) is a National Cancer Institute (NCI) grant mechanism that supports late-stage exploratory work to push promising biospecimen technologies closer to real-world use in cancer research and clinical care. The core problem it targets is pre-analytical variation: the avoidable damage, loss, or distortion of important biological molecules (analytes) that can happen before a sample is ever analyzed, during collection, processing, handling, transport, or storage. Because these early steps can heavily influence results, the FOA is focused on technologies that can preserve specimen integrity or make specimen quality more measurable and verifiable, so downstream research findings and clinical tests are more reliable and reproducible.
This opportunity uses the R33 activity code and is explicitly labeled "Clinical Trial Not Allowed," meaning the work should not involve prospective assignment of human participants to interventions for health outcomes. Instead, the emphasis is on technology development and validation studies that can be performed using appropriate biospecimens, model systems, or observational sample resources. The R33 scope is important: applicants are expected to have already cleared the biggest feasibility risks and to provide supportive preliminary data showing the approach is workable. What remains, and what the FOA is designed to fund, is further development, optimization, and especially rigorous validation to demonstrate performance, robustness, and practical utility at a level that encourages broader adoption by the research community.
The FOA seeks highly innovative technologies that either maximize biospecimen quality or directly interrogate and quantify it. Supported projects may include new tools, devices, instrumentation, and associated methods that protect samples from degradation or otherwise stabilize key analytes under real handling conditions. Another major fit is technology that establishes objective verification criteria for quality assessment and quality control, including methods that can confirm whether a sample has been compromised, determine whether it is fit-for-purpose for a given assay, or guide standardized handling under diverse conditions. In effect, the program is looking for solutions that reduce noise and bias introduced before analysis, which can translate into clearer biological signals and fewer irreproducible findings.
In terms of impact, the FOA frames biospecimen quality improvements as an enabling step for many areas of cancer work, including fundamental cancer biology, early detection and screening, clinical diagnosis, treatment decision support, and population-based or epidemiologic studies. By reducing pre-analytical variability, these technologies are expected to improve the accuracy and consistency of molecular measurements and other downstream analyses, which can speed up discovery and improve confidence in results. The announcement also highlights relevance to cancer health disparities, recognizing that differences in collection settings, resources, and workflows can disproportionately affect sample quality across populations; technologies that perform well across diverse real-world contexts can help reduce systematic inequities in research and clinical interpretation.
Administratively, this is a discretionary grant from the U.S. Department of Health and Human Services through NIH/NCI, listed under CFDA 93.394, and it sits within NCI's broader Innovative Molecular Analysis Technologies (IMAT) Program. Eligibility is broad and includes many organization types such as state, local, and tribal governments; public and private institutions of higher education; nonprofit organizations with or without 501(c)(3) status; for-profit organizations (including small businesses and other for-profits); and other applicants as described in the FOA's eligibility section. The posted award ceiling is $300,000, and the FOA anticipated making about 2 awards. The FOA was created November 20, 2017, with an original closing date of September 28, 2018, indicating it was issued for a specific competition window, even though its goals and program framing remain useful for understanding what NCI sought to advance in biospecimen science.
Overall, the opportunity is best understood as a push to move beyond "promising prototype" and into "validated, adoptable technology" for biospecimen quality. The ideal R33 project under this FOA is one where the concept has already been demonstrated, but additional engineering, method refinement, and carefully designed validation studies are needed to prove reliability across conditions and specimen types, define performance limits, and provide the kind of evidence the broader cancer research ecosystem needs before changing standard biospecimen practices.Apply for RFA CA 18 005
- The Department of Health and Human Services, National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Advanced Development and Validation of Emerging Biospecimen Science Technologies for Basic and Clinical Cancer Research (R33 - Clinical Trial Not Allowed)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.394.
- This funding opportunity was created on Nov 20, 2017.
- Applicants must submit their applications by Sep 28, 2018. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Each selected applicant is eligible to receive up to $300,000.00 in funding.
- The number of recipients for this funding is limited to 2 candidate(s).
- Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For profit organizations other than small businesses, Small businesses, Others (see text field entitled Additional Information on Eligibility for clarification).
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Frequently Asked Questions (FAQs)
What is the name of this funding opportunity?
The opportunity is titled "Advanced Development and Validation of Emerging Biospecimen Science Technologies for Basic and Clinical Cancer Research" and is referenced as RFA-CA-18-005.
Which agency is offering this grant?
This is a National Cancer Institute (NCI) funding opportunity under the National Institutes of Health (NIH), within the U.S. Department of Health and Human Services (HHS).
What is the main purpose of this FOA?
The FOA supports late-stage exploratory work to move promising biospecimen science technologies closer to real-world use in cancer research and clinical care, with an emphasis on development, optimization, and rigorous validation.
What problem is the FOA trying to solve?
It targets pre-analytical variation, meaning avoidable damage, loss, or distortion of important biological molecules (analytes) that can occur before a specimen is analyzed, during collection, processing, handling, transport, or storage.
What does "pre-analytical variation" mean in practical terms?
It refers to changes introduced to biospecimens before testing, such as degradation or instability of analytes, or other handling-related effects that can influence downstream measurements and lead to less reliable or less reproducible results.
What kinds of projects does this FOA aim to fund?
It aims to fund highly innovative biospecimen technologies that either (1) preserve and maximize biospecimen quality or (2) directly interrogate, quantify, and verify biospecimen quality using objective criteria.
What types of technologies are considered a fit?
Examples described in the FOA include new tools, devices, instrumentation, and associated methods designed to protect samples from degradation, stabilize key analytes under real handling conditions, or provide measurable and verifiable quality assessment and quality control.
Is the focus more on invention or on validation?
The FOA is focused on advanced development and especially rigorous validation. Applicants are expected to have already addressed major feasibility risks and to include supportive preliminary data showing the approach is workable.
What stage of maturity should a technology be at for an R33 under this FOA?
The intended stage is beyond a "promising prototype" and closer to a "validated, adoptable technology." The concept should already be demonstrated, with remaining work centered on refinement, performance testing, robustness, and practical utility.
What is the grant mechanism/activity code used?
This opportunity uses the NIH R33 activity code.
Are clinical trials allowed under this FOA?
No. The FOA is explicitly labeled "Clinical Trial Not Allowed," meaning the work should not involve prospective assignment of human participants to interventions to evaluate health outcomes.
If clinical trials are not allowed, what kinds of studies are appropriate?
Appropriate work includes technology development and validation studies that can be performed using biospecimens, model systems, or observational sample resources, as long as the work does not meet the definition of a clinical trial under the FOA.
What does the FOA mean by improving "specimen integrity"?
It refers to preserving the quality of the biospecimen so key analytes are not degraded or distorted by collection and handling steps, helping ensure downstream analyses reflect true biology rather than artifacts.
What is meant by making biospecimen quality "measurable and verifiable"?
It means developing methods and criteria that objectively assess whether a sample has been compromised, whether it is fit-for-purpose for a given assay, or how handling can be standardized under diverse conditions.
Why is biospecimen quality important for cancer research and clinical care?
Because early specimen handling can heavily influence results, improving biospecimen quality can improve the accuracy, consistency, and reproducibility of downstream molecular measurements and other analyses.
What areas of cancer research does the FOA describe as benefiting from improved biospecimen quality?
The FOA highlights relevance to fundamental cancer biology, early detection and screening, clinical diagnosis, treatment decision support, and population-based or epidemiologic studies.
How does the FOA connect biospecimen technology to reproducibility?
By reducing pre-analytical variability, these technologies are expected to reduce noise and bias introduced before analysis, which can lead to clearer biological signals and fewer irreproducible findings.
Does the FOA mention cancer health disparities?
Yes. It notes that differences in collection settings, resources, and workflows can disproportionately affect sample quality across populations, and that technologies that perform well across diverse real-world contexts can help reduce systematic inequities in research and clinical interpretation.
What program within NCI is this FOA associated with?
It sits within NCI's Innovative Molecular Analysis Technologies (IMAT) Program.
What is the CFDA number for this opportunity?
The listing provided is CFDA 93.394.
What is the posted award ceiling?
The posted award ceiling is $300,000.
How many awards were anticipated?
The FOA anticipated making about 2 awards.
Who is eligible to apply?
Eligibility is described as broad and includes state, local, and tribal governments; public and private institutions of higher education; nonprofit organizations with or without 501(c)(3) status; for-profit organizations (including small businesses and other for-profits); and other applicants as described in the FOA's eligibility section.
Is this a discretionary grant?
Yes. It is described as a discretionary grant from HHS through NIH/NCI.
When was this FOA created and when did it close?
The FOA was created on November 20, 2017, and had an original closing date of September 28, 2018, indicating it was issued for a specific competition window.
What is the overall "best fit" project profile described by the FOA?
An ideal project has already demonstrated the core concept and feasibility, and uses R33 support to complete additional engineering, method refinement, and carefully designed validation studies to prove reliability across conditions and specimen types, define performance limits, and generate evidence that encourages broader adoption.
What does the FOA mean by "fit-for-purpose" biospecimens?
It refers to determining whether a sample meets the quality needs for a specific downstream assay or analysis, based on objective verification criteria and measurable quality indicators.
Does the FOA emphasize real-world handling conditions?
Yes. It explicitly highlights technologies that stabilize analytes and protect samples under real handling conditions, including the steps where degradation can occur (collection, processing, handling, transport, and storage).
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