Opportunity Information: Apply for PA 12 014
Apply for PA 12 014
- The National Institutes of Health in the education health sector is offering a public funding opportunity titled "Validation of Molecular Diagnostics to Predict Patient Outcomes Using Specimens from Multi Site Cancer Trials (R21)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.394 Cancer Detection and Diagnosis Research 93.395 Cancer Treatment Research.
- This funding opportunity was created on Nov 16, 2011 and posted on Nov 16, 2011.
- Applicants must submit their applications by Jan 7, 2015. (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 $275,000.00 in funding.
- Eligible applicants include: Private institutions of higher education State governments City or township governments Independent school districts 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 County governments Others (see text field entitled Additional Information on Eligibility for clarification) Small businesses Public housing authorities/Indian housing authorities Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education For profit organizations other than small businesses Public and State controlled institutions of higher education Special district governments Native American tribal governments (Federally recognized).
- Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions 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) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession Non domestic (non U.S.) Entities (Foreign Institutions) are eligible to apply. Non domestic (non U.S.) components of U.S. Organizations are t eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
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Opportunity Summary:
This grant opportunity, titled "Validation of Molecular Diagnostics to Predict Patient Outcomes Using Specimens from Multi-Site Cancer Trials (R21)" (Funding Opportunity Number PA-12-014), was issued by the National Cancer Institute (NCI) within the National Institutes of Health (NIH). It is an R21 Exploratory/Developmental Research Project Grant mechanism, meaning it is designed to fund early, high-impact pilot work that can rapidly test feasibility and generate convincing evidence needed to move a tool closer to real clinical use. The central goal is not to find new biomarkers, but to validate the clinical utility of molecular diagnostics that already have promising preliminary evidence. In practical terms, the FOA is aimed at determining whether a candidate molecular test can reliably help predict cancer patient prognosis, forecast response to a specific therapy, or anticipate treatment-related toxicity, using real-world clinical trial specimens and linked outcomes.
A key emphasis of the program is the transition of candidate biomarkers from initial correlative observations into diagnostics that are truly suitable for use in clinical trials and, ultimately, clinical decision-making. The NCI Cancer Diagnosis Program (CDP) and the Cancer Therapy Evaluation Program (CTEP) jointly sponsor the announcement, reflecting the intent to connect diagnostics development directly to therapeutics evaluation. Projects supported under this FOA are expected to leverage tumor (and potentially other relevant) specimens that are tied to specific treatments and well-annotated clinical outcome data, particularly specimens derived from multi-site cancer trials. That multi-site setting matters because it helps demonstrate that a diagnostic performs consistently across different institutions, patient populations, and handling environments, which is often where promising assays fail when they move beyond a single lab or single cohort.
The research scope is focused on validating clinical utility and clinical validity in a trial-linked context, rather than basic discovery. The announcement explicitly states it is not appropriate for molecular diagnostics discovery projects, which signals that applications proposing to hunt for new markers, perform broad exploratory -omics screening without a defined candidate, or generate initial hypotheses without a clear validation plan would not fit. Instead, the expectation is that applicants bring forward a defined molecular diagnostic approach (for example, a gene expression signature, mutation panel, methylation marker set, or other molecular assay) and propose a rigorous validation strategy using specimens where treatment exposure and outcomes are already known. The intended end point is to strengthen evidence that the diagnostic can be used to guide or improve decisions in cancer care, such as identifying which patients are likely to benefit from a therapy, which patients may not respond, or who may be at higher risk for adverse effects.
From an administrative standpoint, this is a discretionary grant program with no cost sharing or matching requirement. The award ceiling listed is $275,000. The opportunity was posted on November 16, 2011, with an original and final closing date of January 7, 2015, and it was archived on February 7, 2015. The activity aligns with NIH cancer research program areas reflected in CFDA numbers 93.394 (Cancer Detection and Diagnosis Research) and 93.395 (Cancer Treatment Research).
Eligibility is broad and includes many organization types across academia, government, nonprofit, and industry. Eligible applicants include private and public institutions of higher education, state and local governments (including counties, cities/townships, special districts), independent school districts, public housing authorities/Indian housing authorities, small businesses, and for-profit organizations other than small businesses, as well as nonprofits both with and without 501(c)(3) status. The eligibility language also highlights a wide range of mission-driven and community-based entities, including faith-based and community-based organizations, Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and tribal governments (federally recognized and other than federally recognized), along with regional organizations and U.S. territories or possessions. Foreign institutions (non-U.S. entities) are eligible to apply, and foreign components as defined by NIH policy are allowed, while non-domestic components of U.S. organizations are stated as not eligible.
Overall, the FOA is best understood as a bridge-building funding mechanism: it supports relatively focused, well-justified pilot validation studies that can move a molecular diagnostic from "interesting association" to "clinically meaningful tool" by testing it against outcome-linked specimens from rigorously conducted, multi-site cancer trials. The intent is to produce evidence strong enough to justify broader clinical trial use of the diagnostic and to improve the quality of clinical decision-making for cancer patients.
Frequently Asked Questions (FAQs)
What is the official title of this grant opportunity?
The opportunity is titled "Validation of Molecular Diagnostics to Predict Patient Outcomes Using Specimens from Multi-Site Cancer Trials (R21)."
What is the Funding Opportunity Number (FOA number)?
The Funding Opportunity Number is PA-12-014.
Which agency issued this funding opportunity?
This FOA was issued by the National Cancer Institute (NCI), which is part of the National Institutes of Health (NIH).
What grant mechanism does this FOA use?
This opportunity uses the R21 Exploratory/Developmental Research Project Grant mechanism, which is intended to support early, potentially high-impact pilot work to test feasibility and generate evidence needed to move a tool closer to clinical use.
What is the main purpose of this FOA?
The main purpose is to validate the clinical utility (and clinical validity in a trial-linked context) of molecular diagnostics that already have promising preliminary evidence, using specimens and outcome data from multi-site cancer trials.
Is this FOA meant for discovering new biomarkers?
No. The announcement explicitly indicates it is not appropriate for molecular diagnostics discovery projects. Applications focused on identifying new biomarkers or performing broad exploratory screening without a defined candidate are not a fit.
What kinds of research questions are a good fit for this opportunity?
Projects should test whether a defined molecular diagnostic can reliably predict cancer patient prognosis, forecast response to a specific therapy, or anticipate treatment-related toxicity, using clinical trial specimens linked to known treatments and well-annotated outcomes.
What does the FOA mean by "validation" in this context?
In this FOA, validation refers to moving a candidate diagnostic beyond an initial correlative observation by rigorously testing its performance in specimens tied to specific treatments and clinical outcomes, with the aim of demonstrating it is suitable for use in clinical trials and potentially clinical decision-making.
What types of molecular diagnostics are examples of what could be validated?
Examples described include a gene expression signature, a mutation panel, a methylation marker set, or other defined molecular assay, as long as the application focuses on validation rather than discovery.
Why does the FOA emphasize multi-site cancer trials?
Multi-site trials help test whether a diagnostic performs consistently across different institutions, patient populations, and specimen handling environments. This is important because assays that work in a single lab or single cohort may fail to replicate in broader settings.
What types of specimens are expected to be used?
Projects are expected to leverage tumor specimens and potentially other relevant specimen types, provided they are tied to specific treatments and linked to well-annotated clinical outcome data, particularly from multi-site cancer trials.
How does this FOA connect diagnostics development to therapeutics evaluation?
The FOA is jointly sponsored by the NCI Cancer Diagnosis Program (CDP) and the Cancer Therapy Evaluation Program (CTEP), reflecting an intent to align diagnostics validation with evaluation of cancer therapies.
What are the intended outcomes or endpoints of projects funded under this FOA?
The intent is to strengthen evidence that the diagnostic can be used to guide or improve decisions in cancer care, such as identifying patients likely to benefit from a therapy, patients unlikely to respond, or patients at higher risk for adverse effects.
Is cost sharing or matching required?
No. This is described as a discretionary grant program with no cost sharing or matching requirement.
What is the maximum award amount mentioned for this opportunity?
The award ceiling listed is $275,000.
When was this funding opportunity posted?
It was posted on November 16, 2011.
What were the closing dates for this FOA?
The original and final closing date listed is January 7, 2015.
What does it mean that the opportunity is archived?
The listing states the FOA was archived on February 7, 2015, indicating it is no longer an active, open opportunity under that posting.
Which CFDA program areas does this opportunity align with?
This activity aligns with CFDA 93.394 (Cancer Detection and Diagnosis Research) and 93.395 (Cancer Treatment Research).
Who is eligible to apply?
Eligibility is broad and includes many organization types across academia, government, nonprofit, and industry, as described in the FOA summary.
Are higher education institutions eligible?
Yes. Both private and public institutions of higher education are listed as eligible applicants.
Are government entities eligible to apply?
Yes. State and local governments are eligible, including counties, cities/townships, and special districts, as well as independent school districts.
Are housing authorities eligible?
Yes. Public housing authorities and Indian housing authorities are included in the eligibility list.
Are small businesses eligible?
Yes. Small businesses are listed as eligible applicants.
Are for-profit organizations eligible?
Yes. For-profit organizations other than small businesses are listed as eligible.
Are nonprofit organizations eligible?
Yes. Nonprofits with 501(c)(3) status and nonprofits without 501(c)(3) status are both included as eligible.
Are faith-based and community-based organizations eligible?
Yes. The eligibility language highlights faith-based and community-based organizations among the entities that may apply.
Are HBCUs and other minority-serving institutions eligible?
Yes. Eligibility highlights Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribally Controlled Colleges and Universities (TCCUs), and Alaska Native and Native Hawaiian Serving Institutions.
Are tribal governments eligible?
Yes. Tribal governments (federally recognized and other than federally recognized) are included as eligible applicants, along with certain regional organizations and U.S. territories or possessions.
Can foreign institutions apply?
Yes. Foreign institutions (non-U.S. entities) are stated as eligible to apply, and foreign components as defined by NIH policy are allowed.
Are non-domestic components of U.S. organizations eligible?
No. The FOA states that non-domestic components of U.S. organizations are not eligible.
What is the practical "bridge" this FOA is trying to build?
It is designed to bridge the gap between an "interesting association" and a "clinically meaningful tool" by supporting focused validation studies that use rigorously conducted, multi-site trial specimens with linked outcomes to produce evidence strong enough to justify broader clinical trial use and improve clinical decision-making.
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| The Chernobyl Tissue Bank Coordinating Center (Limited Competition U24) Apply for RFA CA 12 501 Funding Number: RFA CA 12 501 Agency: National Institutes of Health Category: Education Health Funding Amount: $250,000 |
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