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

Opportunity Summary:

The grant opportunity titled "The Early Detection Research Network: Biomarker Developmental Laboratories (U01)" (Funding Opportunity Number RFA-CA-16-009) is a National Institutes of Health (NIH) cooperative agreement aimed at expanding the Early Detection Research Network (EDRN), a national research infrastructure focused on improving how cancers are found earlier and characterized more accurately. EDRN supports the full pipeline of biomarker science, from discovery through development and validation, with the overarching goal of enabling better risk assessment, earlier detection, and improved molecular diagnosis and prognosis, especially at stages when intervention can be most effective.

This announcement specifically solicits organ-focused applications for Biomarker Developmental Laboratories (BDLs), which are one of four core scientific units within EDRN. In practical terms, a BDL is expected to function as a specialized laboratory hub that identifies promising biomarkers, improves and refines biomarker candidates and assays, and then rigorously characterizes and tests them. The work supported is not limited to completely new biomarkers; it also includes the refinement of existing biomarkers and the improvement of assay methods so they become more reliable, reproducible, and suitable for broader research and eventual clinical translation. The emphasis is on biomarkers that can inform cancer risk, detect disease earlier, and support molecular-level diagnosis and prognosis.

A key driver for this FOA is that the existing EDRN BDL portfolio at the time was largely concentrated on ovarian and gastrointestinal cancers. NIH is using this funding to rebalance and broaden coverage by adding new BDLs that must focus on specific high-priority cancer areas: breast cancer, prostate cancer and other genitourinary cancers, and lung cancer. Beyond those required focus areas, the FOA also signals strong interest in cancers with rapidly increasing incidence, such as endometrial, hepatocellular (liver), kidney, thyroid, and oropharyngeal cancers. It also welcomes proposals addressing cancers with distinctive causes or exposures, with mesothelioma called out as an example of a cancer with unique etiology. This framing makes clear that NIH is looking both to fill gaps in the current EDRN structure and to respond to evolving cancer trends where earlier detection tools are urgently needed.

The funding mechanism is a U01 cooperative agreement, which generally means NIH expects to have substantial scientific involvement during the project period compared to a standard research grant. Applicants should anticipate coordinated work within the EDRN ecosystem, including alignment with network priorities, collaboration across sites, and contribution to shared goals and resources. In other words, the award is designed to support laboratories that can operate not just as stand-alone research groups, but as active components of a national, team-science program focused on deliverables that move biomarker candidates toward credible early detection and clinical utility.

Eligibility is broad and includes state governments, public and state-controlled institutions of higher education, private institutions of higher education, nonprofit organizations (both 501(c)(3) and non-501(c)(3)), for-profit organizations (other than small businesses), small businesses, and other organizations as allowed under the FOA. The sponsoring agency is HHS/NIH (listed as HHS-NIH11). The opportunity was posted on March 17, 2016, and had a closing date of May 23, 2016. While the notice does not list an award ceiling or the expected number of awards in the provided fields, the overall intent is clear: to fund additional organ-specific BDLs that can strengthen the EDRN pipeline for early cancer biomarker development, particularly in breast, lung, and genitourinary malignancies, while also encouraging work in emerging high-incidence or uniquely caused cancers.

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