The Early Detection Research Network Biomarker Developmental Laboratories (U01) | Apply Online

Frequently Asked Questions (FAQs)

What is the Early Detection Research Network (EDRN) Biomarker Developmental Laboratories (U01) opportunity?

This is a National Cancer Institute (NCI), National Institutes of Health (NIH) funding announcement (Funding Opportunity Number RFA-CA-09-017) that supports Biomarker Developmental Laboratories (BDLs) working on cancer biomarkers. The focus is on biomarkers aimed at finding cancer earlier, assessing cancer risk, and improving molecular diagnosis and prognosis in early-stage disease.

What is the main purpose of this funding opportunity?

The purpose is to support laboratories that can take a promising cancer biomarker (or improve an existing one) and do the development work needed to make it credible, reproducible, and ready for downstream validation in clinical settings. The emphasis is on coordinated development, careful characterization, and structured validation readiness within the EDRN consortium.

What is a Biomarker Developmental Laboratory (BDL) in the EDRN context?

A BDL is the EDRN component responsible for developing and characterizing new biomarkers and refining existing biomarkers and biomarker assays. BDLs generate standardized methods and supporting evidence so other EDRN units can test biomarkers more broadly and consistently.

What kinds of activities are BDLs expected to perform?

BDLs are expected to develop, optimize, and characterize biomarker assays. This includes improving assay performance and establishing analytical characteristics such as sensitivity, specificity, dynamic range, reproducibility, robustness, and feasibility, along with producing standardized methods and evidence suitable for network-wide comparison and multi-site testing.

Is this opportunity about discovering new biomarkers, validating them clinically, or both?

Based on the description, the funded role is centered on development and characterization (and refining assays) rather than serving as the primary clinical validation arm. The expectation is to produce test-ready biomarker assays and supporting data that can move into broader validation pathways supported by other EDRN components.

What does it mean that this is a U01 cooperative agreement?

This opportunity uses the NIH cooperative agreement mechanism (U01), which is designed for projects where NIH program staff have substantial involvement beyond a typical grant. In practice, this implies active partnership, coordination expectations, and shared responsibilities between awardees and NIH, including collaboration and alignment with network standards and priorities.

How does a BDL relate to the broader EDRN structure?

BDLs are one part of a coordinated system within EDRN. The broader structure also includes Biomarker Reference Laboratories (BRLs), Clinical Validation Centers (CVCs), and the Data Management and Coordinating Center (DMCC). Together, these components are meant to move biomarkers from development to validation in a coherent, multi-site framework.

What are Biomarker Reference Laboratories (BRLs), and how do they differ from BDLs?

BRLs serve as network resources for clinical and laboratory validation of biomarkers by providing standardized reference capacity and validation support. BDLs, by contrast, focus on developing and characterizing biomarkers and improving assays so they are ready for downstream validation.

What are Clinical Validation Centers (CVCs), and what role do they play?

CVCs conduct clinical research focused on validating biomarkers for early detection and risk assessment. They also act as resource centers by joining collaborative validation studies and working closely with BDLs and BRLs.

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

The DMCC provides statistical and computational analysis support, informatics infrastructure, and coordinates network-wide meetings and conferences. It supports the data and coordination needed to make multi-site science comparable and coherent.

What types of outcomes does this FOA appear to prioritize?

The opportunity emphasizes developed biomarker tools: well-characterized, test-ready biomarker assays with standardized methods and supporting data that can stand up to network-wide comparison, multi-site testing, and eventual clinical validation. The intended endpoint is not only publications or preliminary findings but biomarker assays ready for rigorous validation pathways.

What is the award ceiling listed for this opportunity?

The listing includes an award ceiling of $400,000 (as provided in the source data).

How much funding did NCI expect to commit, and how many awards were anticipated?

The announcement states that NCI expected to commit about $10 to $11 million per year to support roughly 20 to 25 BDL awards.

Is cost sharing or matching required?

No. The opportunity states that it does not require cost sharing or matching.

Who is eligible to apply?

Eligibility is described as broad and includes: public and state-controlled institutions of higher education; private institutions of higher education; nonprofit organizations (including 501(c)(3) organizations and certain nonprofits without 501(c)(3) status); small businesses; and for-profit organizations other than small businesses. It also includes eligible agencies of the federal government, U.S. territories or possessions, and non-U.S. entities (foreign organizations).

Does this opportunity allow non-U.S. (foreign) organizations to apply?

Yes. The eligibility language explicitly includes non-U.S. entities (foreign organizations).

What is the relevant agency and institute behind this opportunity?

The opportunity is an NCI (National Cancer Institute) funding announcement under NIH (National Institutes of Health).

What are the key dates (posted, closing, archive) for this FOA?

The listing shows a posted and creation date of June 26, 2009; an original and current closing date of October 29, 2009; and an archive date of November 29, 2009.

Is this an active funding opportunity?

Based on the dates provided (closing date in 2009 and an archive date in 2009), this appears to be a historical opportunity rather than an active open call.

What is the Funding Opportunity Number (FON) for this announcement?

The Funding Opportunity Number is RFA-CA-09-017.

What is the activity category associated with the opportunity?

The activity category is listed under education and health.

Which CFDA numbers are associated with this program?

The CFDA numbers listed are 93.393 (Cancer Cause and Prevention Research) and 93.394 (Cancer Detection and Diagnosis Research).

Are there related EDRN funding announcements referenced alongside this one?

Yes. The FOA references parallel EDRN component announcements: RFA-CA-09-018 (U01) for Clinical Validation Centers; RFA-CA-09-019 (U24) for Biomarker Reference Laboratories; and RFA-CA-09-020 (U24) for the Data Management and Coordinating Center.

Why does the FOA emphasize collaboration and network standards?

This is a cooperative agreement within the EDRN consortium, so projects are expected to operate as part of a coordinated system. The description highlights structured collaboration, data and protocol sharing, and alignment with network standards and priorities to enable multi-site testing and comparable results across the network.

What is the basic end-to-end pathway described for biomarker work within EDRN?

The described pathway is: BDLs develop and optimize biomarkers and assays; BRLs and CVCs help validate them in rigorous laboratory and clinical contexts; and the DMCC supports the data, informatics, statistical analysis, and coordination needed for network-wide work.

What kinds of biomarker goals are explicitly mentioned?

The opportunity mentions biomarkers aimed at finding cancer earlier, assessing risk, and improving molecular diagnosis and prognosis in early-stage disease.