Resources for Sites Providing Diagnostic Services for Patients with Undiagnosed Diseases

Funding News Edition: May 03, 2023
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NIAID is one of many NIH institutes and centers (ICs) participating in the new notice of funding opportunity (NOFO) Diagnostic Centers of Excellence (X01, Clinical Trial Not Allowed). The NOFO’s purpose is to deliver infrastructure, data management, and clinical research support to established clinical sites that provide diagnostic services for patients with undiagnosed diseases.

To be clear, ICs will not award funding through the X01 mechanism. Instead, the Undiagnosed Diseases Network’s Data Management Coordinating Center (DMCC) will designate successful applicants’ clinical sites as Diagnostic Centers of Excellence (DCoEs). Each DCoE will generate participant clinical phenotypic and sequencing data and submit them to DMCC. At the same time, DMCC will give DCoEs access to high-quality phenotypic and genotypic data and collaborators including highly skilled physicians, researchers, and bioinformaticians.

Your application should demonstrate that your clinical site has a track record of diagnosing rare and difficult-to-diagnose disorders, with appropriate expertise as well as the infrastructure and resources needed to conduct clinical evaluation and DNA sequencing of participants enrolled at your site.

Ideally, your site currently has the capacity to:

  • Enroll a minimum of five participants each year who are accepted into the Network.
  • Perform DNA or RNA sequencing and re-analysis of existing genome-sequencing data.
  • Work with Undiagnosed Diseases Network data stored in a cloud architecture.
  • Collect and store DNA, fibroblasts from skin biopsies, and other biological specimens.

The NOFO itself lists additional areas of expertise that your site should already possess.

Odds and Ends

DMCC may make small subawards ($25,000 to $50,000) to DCoE sites. The subawards will support costs associated with on-site coordination and submitting data to the Network; and pilot research projects such as early-stage gene function studies in model systems and clinical genomics or metabolomics investigations.

The initiative has several other unique attributes which the NOFO describes in greater detail. As you consider whether to apply, keep in mind the following:

  • DCoEs must incorporate Network-wide protocols and operations.
  • DCoEs will use a single institutional review board managed by NIH’s Undiagnosed Diseases Program.
  • DCoEs must submit relevant participant datasets to DMCC.

In addition, each DCoE’s contact principal investigator will serve on a Network Steering Committee responsible for identifying scientific and policy issues that need to be addressed at a Network-wide level and ensuring dissemination of undiagnosed diseases clinical practice and research knowledge to the wider scientific community.

Practical Matters

Your proposed project period can be a minimum of 3 years and a maximum of 5 years.

Your application cannot propose a clinical trial. Refer to NIH’s Definition of a Clinical Trial if you are unsure whether your project qualifies.

Foreign institutions are not eligible to apply. However, foreign components are allowed.

Applications are first due on May 15, 2023. There are two additional future deadlines: May 15, 2024, and May 15, 2025.

If you have any questions, direct them to Dr. Stacy Ferguson, NIAID’s scientific/research contact for the NOFO, at or 240-627-3504.

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