Opportunity Information: Apply for RFA CA 19 022
The National Cancer Institute (NCI), within the National Institutes of Health (NIH) at the Department of Health and Human Services, offered this grant opportunity to push forward practical, high-impact technologies that make cancer-related biospecimens more reliable for research and clinical use. The focus is on the often-overlooked period before a specimen is analyzed, meaning everything that happens during collection, processing, handling, and storage. During these steps, important biological signals (targeted analytes such as DNA, RNA, proteins, metabolites, and other molecular markers) can degrade or change, introducing pre-analytical variation that can distort results. This FOA centers on technologies that reduce those problems by preserving sample integrity, monitoring quality in real time or after the fact, and creating stronger, more standardized ways to verify that a sample is still fit for downstream testing.
This announcement specifically used the R33 funding mechanism, which is generally meant for later-stage exploratory and developmental work where the basic feasibility has already been demonstrated. In other words, applicants were expected to come in with solid preliminary data showing that the core concept works and that the biggest feasibility risks have been addressed. The remaining work should still be significant: further development, optimization, and, most importantly, rigorous validation so that the technology is credible and adoptable by the broader research community. The intent is not just to build clever prototypes, but to produce tools, devices, instruments, or methods that can be trusted, compared across settings, and realistically integrated into workflows used by biobanks, research labs, and clinical environments.
A central theme of the FOA is improving the quality and utility of biological samples used for downstream analyses. That can include technologies that actively protect specimens from degradation (for example, improved stabilization approaches, better collection devices, smarter storage or transport solutions, or methods that minimize handling damage), as well as technologies that interrogate specimen quality (for example, quality assessment/quality control systems, verification criteria, or metrics that indicate whether a sample has been compromised). The FOA also emphasizes performance under diverse conditions, recognizing that real-world biospecimen collection happens across many environments with different resources, time constraints, and infrastructure. Methods that can handle variability in temperature, delays before processing, shipping conditions, or inconsistent handling practices are particularly relevant because they address a major source of irreproducibility in cancer research and inconsistency in clinical testing.
By reducing pre-analytical variation, the funded projects were expected to strengthen multiple areas of cancer science and care. Better biospecimens can improve basic cancer biology studies by ensuring measured molecular changes reflect biology rather than handling artifacts. They can enhance early detection and screening by making low-abundance signals easier to detect and by reducing false negatives or misleading biomarker fluctuations. They can also support clinical diagnosis and treatment decisions by improving the reliability of molecular profiling and other lab-based assessments. Beyond individual patient care and lab studies, improved biospecimen quality matters in epidemiology and population research, where samples collected across sites and time periods need consistent handling to allow valid comparisons. The FOA also highlights the potential to address cancer health disparities, since inconsistent collection conditions and resource limitations can disproportionately affect sample quality in certain settings; robust, field-tolerant technologies can help make data quality more equitable across populations.
This opportunity was part of NCI's broader Innovative Molecular Analysis Technologies (IMAT) Program, which aims to accelerate the creation and adoption of transformative technologies that enable better molecular measurements and analyses in cancer. While IMAT often brings to mind novel assays or molecular detection platforms, this FOA zeroes in on the upstream foundation that those assays depend on: the specimen itself. The underlying message is that even the best analytical methods cannot compensate for poorly preserved or poorly characterized inputs, so investments in biospecimen science technologies can have outsized downstream impact.
Administratively, the FOA was identified as RFA-CA-19-022 under the assistance listing (CFDA) 93.394. It was a discretionary grant program with an award ceiling listed at $300,000, and the expected number of awards was two. The announcement allowed a wide range of applicants, including federal recognized tribal governments and tribal organizations, state and local 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 entities as described in the eligibility text. The FOA was posted in early January 2019 with an original closing date in late September 2019. It explicitly indicated that clinical trials were not allowed under this funding mechanism, signaling that the supported work should focus on technology development and validation rather than testing interventions through clinical trial designs.
Overall, the grant opportunity targeted a clear bottleneck in cancer research and clinical translation: inconsistent biospecimen quality and the hidden damage caused by pre-analytical factors. It sought projects that are past the initial "can it work" stage and ready for disciplined engineering, refinement, and validation work that demonstrates reliability, robustness, and practical value. The goal was to deliver emerging technologies that the cancer research community can adopt to generate cleaner data, more comparable results across studies and sites, and ultimately faster progress in understanding, detecting, and treating cancer.Apply for RFA CA 19 022
- 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 Trials 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 Jan 07, 2019.
- Applicants must submit their applications by Sep 27, 2019. (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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FAQs: NCI/NIH Grant Opportunity (RFA-CA-19-022) on Biospecimen Pre-Analytical Technologies (R33)
What is the main purpose of this funding opportunity?
The opportunity is meant to advance practical, high-impact technologies that improve the reliability of cancer-related biospecimens for research and clinical use. It focuses on reducing problems introduced before a specimen is analyzed, including collection, processing, handling, transport, and storage.
Which part of the biospecimen workflow does the FOA focus on?
The FOA targets the pre-analytical period, meaning everything that happens to a biospecimen before downstream testing or analysis. This includes steps where biological signals can degrade or shift due to temperature changes, delays, handling damage, or storage conditions.
What problem is the FOA trying to solve?
It aims to reduce pre-analytical variation, which can distort results when key analytes (like DNA, RNA, proteins, metabolites, and other molecular markers) degrade or change during collection and handling. This variation can lead to irreproducible findings in research and inconsistent results in clinical testing.
What kinds of analytes or biological signals are mentioned?
The FOA specifically notes targeted analytes such as DNA, RNA, proteins, metabolites, and other molecular markers that can be sensitive to pre-analytical conditions.
What types of technologies were encouraged?
Technologies were encouraged if they (1) preserve or protect specimen integrity or (2) assess/verify specimen quality. Examples mentioned include improved stabilization approaches, better collection devices, smarter storage or transport solutions, and quality assessment/quality control systems or metrics that indicate whether a sample has been compromised.
Is the goal to build prototypes, or something beyond prototypes?
The intent goes beyond clever prototypes. The FOA emphasizes producing tools, devices, instruments, or methods that can be trusted, compared across settings, and realistically integrated into biobanks, research labs, and clinical workflows.
What does “pre-analytical variation” mean in this context?
It refers to unwanted changes and inconsistencies introduced before analytical testing, often caused by differences in collection conditions, processing delays, handling practices, shipping environments, and storage parameters. These factors can alter or degrade analytes and create artifacts that masquerade as true biology.
Why does the FOA emphasize performance under diverse real-world conditions?
Because biospecimen collection occurs across many environments with different levels of infrastructure, staffing, and time constraints. The FOA highlights the importance of methods that remain reliable despite variability such as temperature fluctuations, delays before processing, shipping conditions, or inconsistent handling practices.
How could improving biospecimen quality impact cancer research?
By ensuring that molecular measurements reflect biology rather than handling artifacts, improved biospecimen quality can strengthen basic cancer biology studies and increase confidence that observed molecular changes are real and comparable across experiments and sites.
How could this work support early detection and screening?
Better-preserved and better-characterized samples can make low-abundance signals easier to detect and may reduce false negatives or misleading biomarker fluctuations caused by pre-analytical degradation or instability.
How could these technologies affect clinical diagnosis and treatment decisions?
More reliable biospecimens can improve the consistency and credibility of molecular profiling and other lab-based assessments used to support diagnosis and guide treatment decisions, by reducing sample-related noise and uncertainty.
Why does biospecimen quality matter for epidemiology and population research?
Population research often relies on samples collected across multiple sites and over long time periods. The FOA highlights that consistent handling and robust quality control are necessary to make valid comparisons across locations and cohorts.
Does the FOA mention any connection to cancer health disparities?
Yes. It notes that inconsistent collection conditions and resource limitations can disproportionately affect sample quality in certain settings. Field-tolerant and robust technologies can help make biospecimen quality, and therefore data quality, more equitable across populations.
Which NIH institute offered this opportunity?
The opportunity was offered by the National Cancer Institute (NCI), within the National Institutes of Health (NIH), under the Department of Health and Human Services.
What program is this FOA associated with?
It was part of NCI's Innovative Molecular Analysis Technologies (IMAT) Program, which aims to accelerate development and adoption of transformative technologies for better molecular measurements and analyses in cancer. This FOA specifically focuses on the specimen foundation those analyses depend on.
What is the FOA number and assistance listing (CFDA) number?
The FOA was identified as RFA-CA-19-022 and listed under assistance listing (CFDA) 93.394.
What funding mechanism was used?
This FOA used the R33 mechanism, described as supporting later-stage exploratory and developmental work where basic feasibility has already been demonstrated.
What level of readiness or prior evidence was expected from applicants?
Applicants were expected to have solid preliminary data showing the core concept works and that major feasibility risks have been addressed. The remaining work was expected to focus on further development, optimization, and rigorous validation.
What kind of work was the FOA trying to fund under the R33 mechanism?
The FOA emphasizes disciplined engineering, refinement, and especially validation to demonstrate reliability, robustness, standardization, and practical value, with the goal of broader adoption by the research community.
Were clinical trials allowed?
No. The FOA explicitly indicated that clinical trials were not allowed, signaling that the work should focus on technology development and validation rather than clinical trial designs.
What was the award ceiling and expected number of awards?
The award ceiling was listed at $300,000, and the expected number of awards was two.
What types of organizations were eligible to apply?
The FOA allowed a wide range of applicants, including federal recognized tribal governments and tribal organizations, state and local 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 entities described in the eligibility text.
When was the FOA posted and when did it close?
The FOA was posted in early January 2019, with an original closing date in late September 2019.
What does “fit for downstream testing” mean here?
It refers to whether a biospecimen remains suitable for later analyses after undergoing real-world collection and handling. The FOA emphasizes tools that can preserve integrity and/or provide verification criteria or metrics to confirm the sample has not been compromised.
What is meant by “real-time” versus “after the fact” quality monitoring?
The FOA notes technologies that monitor quality in real time during handling and storage, as well as technologies that assess quality after collection to determine whether the specimen experienced damaging conditions or analyte degradation.
Why does the FOA stress standardization and comparability across settings?
Because inconsistent specimen handling is a major source of irreproducibility and site-to-site variation. The FOA prioritizes approaches that enable stronger, more standardized verification and that support comparisons across laboratories, biobanks, and clinical environments.
What is the broader impact the FOA is aiming for?
The overarching goal is to deliver adoptable technologies that produce cleaner data, improve comparability across studies and sites, and speed progress in understanding, detecting, and treating cancer by addressing a major upstream bottleneck: biospecimen quality.
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