Opportunity Information: Apply for RFA CA 09 019

  • The National Institutes of Health in the education health sector is offering a public funding opportunity titled "The Early Detection Research Network Biomarker Reference Laboratories (U24)" and is now available to receive applicants.
  • Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.393 Cancer Cause and Prevention Research 93.394 Cancer Detection and Diagnosis Research.
  • This funding opportunity was created on Jul 24, 2009 and posted on Jul 24, 2009.
  • Applicants must submit their applications by Oct 29, 2009. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
  • The funding agency has allocated a total of $3,000,000.00 to eligible and selected applicants.
  • Each selected applicant is eligible to receive up to $300,000.00 in funding.
  • Eligible applicants include: Others (see text field entitled Additional Information on Eligibility for clarification) Small businesses For profit organizations other than small businesses Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Public and State controlled institutions of higher education Private institutions of higher education Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education.
  • Other Eligible Applicants include the following Eligible Agencies of the Federal Government U.S. Territory or Possession.
Apply for RFA CA 09 019

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Opportunity Summary:

The funding opportunity RFA-CA-09-019, titled "The Early Detection Research Network Biomarker Reference Laboratories (U24)," is an NIH cooperative agreement solicitation focused on supporting Biomarker Reference Laboratories (BRLs) as a core component of the Early Detection Research Network (EDRN). EDRN is a national consortium built to move cancer biomarkers along a pipeline from discovery to real-world use, with an emphasis on early cancer detection, risk assessment, and improving molecular approaches to diagnosis and prognosis in early-stage disease. In this structure, BRLs are positioned as shared, network-wide resources that help ensure biomarkers and biomarker assays are rigorously validated in both clinical and laboratory settings, and that the underlying technologies and assays are refined so they can perform reliably across studies and sites.

The BRL role in EDRN is primarily about validation infrastructure and standardization. These laboratories are expected to support the clinical and laboratory validation of biomarkers, which typically includes activities like improving assay performance, establishing reproducibility across platforms or sites, conducting method comparisons, and addressing the technical details that can make the difference between a promising marker and one that is dependable enough for broader clinical research. The emphasis on technological development and assay refinement signals that applicants are not only expected to run tests, but also to strengthen and optimize the tools and processes used to measure biomarkers, which is essential when the end goal is credible evidence that a biomarker works in realistic settings.

This FOA sits within a coordinated set of EDRN funding announcements, each supporting a different piece of the overall biomarker development and validation pathway. Alongside BRLs, the network includes Biomarker Developmental Laboratories (BDLs), which concentrate on creating and characterizing new biomarkers or refining existing ones and their assays; Clinical Validation Centers (CVCs), which lead clinical research efforts to validate biomarkers for early detection and risk assessment and collaborate closely with both BDLs and BRLs; and the Data Management and Coordinating Center (DMCC), which provides statistical, computational, and informatics support while also coordinating network meetings and conferences. The parallel solicitations noted in the announcement reflect this division of labor: BDLs and CVCs are supported through U01 mechanisms (RFA-CA-09-017 and RFA-CA-09-018), while the DMCC, like the BRLs, is supported through a U24 mechanism (RFA-CA-09-020). Together, these components are meant to function as an integrated consortium rather than standalone projects, which is reinforced by the use of a cooperative agreement mechanism that anticipates substantial NIH involvement and close coordination across awardees.

Administratively, this is a discretionary funding opportunity offered by the National Institutes of Health under the cooperative agreement funding instrument (U24). It is tied to the NIH cancer research CFDA listings 93.393 (Cancer Cause and Prevention Research) and 93.394 (Cancer Detection and Diagnosis Research). The FOA was posted on July 24, 2009, with an original and current closing date of October 29, 2009, and it was archived on November 29, 2009. The opportunity listed an estimated total funding amount of $3,000,000 and an award ceiling of $300,000, with no cost sharing or matching requirement stated.

Eligibility was broad and included multiple organizational types across the public, private, nonprofit, academic, and federal landscapes. Eligible applicants included small businesses, for-profit entities (both small businesses and other for-profit organizations), nonprofit organizations with and without 501(c)(3) status (excluding higher education institutions in those specific categories as written), public and state-controlled institutions of higher education, private institutions of higher education, and additional eligible applicants such as federal agencies and U.S. territories or possessions. The announcement also provided a link to the full NIH guide notice for details and included contact information for the NIH Office of Extramural Research (OER) webmaster for technical access or linking issues.

Frequently Asked Questions (FAQs)

What is the funding opportunity RFA-CA-09-019?

RFA-CA-09-019 is an NIH cooperative agreement solicitation titled "The Early Detection Research Network Biomarker Reference Laboratories (U24)." It supports Biomarker Reference Laboratories (BRLs) as a core, shared-resource component of the Early Detection Research Network (EDRN), a national consortium focused on moving cancer biomarkers from discovery toward real-world use.

What is the main goal of this opportunity?

The main goal is to support BRLs that provide validation infrastructure and standardization for biomarkers and biomarker assays within the EDRN. The intent is to help ensure biomarkers and assays are rigorously validated and can perform reliably across studies, platforms, and sites.

What is the Early Detection Research Network (EDRN)?

EDRN is a national consortium designed to move cancer biomarkers through a pipeline from discovery to real-world application. Its emphasis includes early cancer detection, risk assessment, and improving molecular approaches to diagnosis and prognosis in early-stage disease.

What is a Biomarker Reference Laboratory (BRL) in the context of EDRN?

A BRL is positioned as a network-wide shared resource that supports the clinical and laboratory validation of biomarkers. BRLs focus on the infrastructure and technical work required to standardize and validate biomarkers and assays so results are dependable and comparable across studies and sites.

What kinds of activities are BRLs expected to support?

Based on the opportunity description, BRLs typically support activities such as improving assay performance, establishing reproducibility across platforms or sites, conducting method comparisons, and addressing technical details that affect whether a biomarker can be reliably used in broader clinical research.

Is this opportunity only about running tests, or does it include technology development?

It includes more than running tests. The description emphasizes technological development and assay refinement, meaning applicants are expected to strengthen and optimize the tools and processes used to measure biomarkers so they perform reliably in realistic settings.

How do BRLs fit into the broader EDRN structure?

BRLs are one part of a coordinated set of EDRN components that function as an integrated consortium. Alongside BRLs, EDRN includes Biomarker Developmental Laboratories (BDLs), Clinical Validation Centers (CVCs), and the Data Management and Coordinating Center (DMCC). Each component supports a different piece of the biomarker development and validation pathway.

What are Biomarker Developmental Laboratories (BDLs), and how are they different from BRLs?

BDLs concentrate on creating and characterizing new biomarkers or refining existing ones and their assays. In contrast, BRLs are positioned primarily around validation infrastructure and standardization, helping ensure biomarkers and assays can be validated and reproduced across studies and sites.

What are Clinical Validation Centers (CVCs), and how do they relate to BRLs?

CVCs lead clinical research efforts to validate biomarkers for early detection and risk assessment. They collaborate closely with both BDLs and BRLs, connecting clinical validation work with assay refinement and standardization efforts across the network.

What is the Data Management and Coordinating Center (DMCC)?

The DMCC provides statistical, computational, and informatics support to the EDRN and coordinates network meetings and conferences. Like BRLs, the DMCC is supported through a U24 mechanism in a parallel solicitation.

What is meant by a "cooperative agreement" (U24) in this announcement?

The opportunity uses the NIH cooperative agreement funding instrument (U24), which is designed for programs that anticipate substantial NIH involvement and close coordination across awardees. The description emphasizes that the EDRN components are meant to operate as an integrated consortium rather than as standalone projects.

Which other EDRN funding announcements are associated with this coordinated set?

The announcement describes parallel solicitations supporting other EDRN components: BDLs and CVCs are supported through U01 mechanisms (RFA-CA-09-017 and RFA-CA-09-018), and the DMCC is supported through a U24 mechanism (RFA-CA-09-020).

Which NIH programs or categories is this opportunity associated with?

This opportunity is tied to NIH cancer research CFDA listings 93.393 (Cancer Cause and Prevention Research) and 93.394 (Cancer Detection and Diagnosis Research).

What agency is offering this funding opportunity?

The funding opportunity is offered by the National Institutes of Health (NIH) as a discretionary funding opportunity under a cooperative agreement mechanism.

When was this opportunity posted, and what were the key dates?

The FOA was posted on July 24, 2009. The original and current closing date listed is October 29, 2009. It was archived on November 29, 2009.

Is this opportunity still open?

No. The opportunity lists a closing date of October 29, 2009, and it was archived on November 29, 2009.

How much total funding was estimated for this opportunity?

The announcement listed an estimated total funding amount of $3,000,000.

What was the award ceiling for individual awards?

The opportunity listed an award ceiling of $300,000.

Is cost sharing or matching required?

No cost sharing or matching requirement was stated in the opportunity description provided.

Who is eligible to apply?

Eligibility is described as broad and includes multiple organization types across public, private, nonprofit, academic, and federal landscapes. Eligible applicants include small businesses; for-profit entities (small businesses and other for-profit organizations); nonprofit organizations with and without 501(c)(3) status (excluding higher education institutions in those specific categories as written); public and state-controlled institutions of higher education; private institutions of higher education; and additional eligible applicants such as federal agencies and U.S. territories or possessions.

Are academic institutions eligible?

Yes. The eligibility list includes public and state-controlled institutions of higher education and private institutions of higher education.

Are for-profit organizations eligible?

Yes. The eligibility list includes small businesses and other for-profit organizations.

Are nonprofit organizations eligible?

Yes. The eligibility list includes nonprofit organizations with 501(c)(3) status and nonprofit organizations without 501(c)(3) status, with a specific note in the description that those categories exclude higher education institutions as written.

Are federal agencies or U.S. territories eligible to apply?

Yes. The eligibility list includes federal agencies and U.S. territories or possessions as additional eligible applicants.

Where can applicants find the full official details for the announcement?

The announcement references a link to the full NIH guide notice for details.

Who should be contacted for technical access or linking issues related to the notice?

The notice includes contact information for the NIH Office of Extramural Research (OER) webmaster for technical access or linking issues.

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Next opportunity: Early Detection Research Network Data Management and Coordinating Center and Statistics and Biomarker Resource Center (U24)

Previous opportunity: Early Detection Research Network Clinical Validation Centers (U01)

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