NIAID’s Diagnostics Development Services program offers reagents, platform testing, and planning and design support to accelerate product development of in vitro diagnostics (IVD) for infectious diseases, from research feasibility through clinical validation.
Main Areas of Focus
The purpose of the program is to offer a comprehensive array of in-kind services to IVD product developers to accelerate progress toward regulatory clearance and commercial launch. This program will support IVD product development spanning late-stage feasibility research through clinical validation. The program is not intended to develop candidate assays through an entire product development pathway, but, rather, to provide gap-filling services to mitigate risk and aid product developers in achieving regulatory clearance and sustainable commercialization on their own.
The suite of services available includes, but may not be limited to:
- Product development process and documentation support, including design control, document control, risk management, design and development planning, manufacturing planning, and regulatory planning
- Assay optimization assistance, including guard-banding, range-finding, limit-of-detection, reproducibility
- Reagent development, production, and quality control, including novel nucleic acids and proteins/peptides
- Nucleic acid amplification support and next-generation and third-generation nucleic acid sequencing
- Immunoassay and lateral flow assay development support
Eligibility Criteria
Eligibility is extended to IVD product developers working on identification and/or characterization of infectious pathogens of high priority to NIAID. Developers may be affiliated with universities, non-government organizations or start-up or mature biotech or biopharma companies, either U.S.-based or international.
Current or previous NIH or other US government funding is not a prerequisite. Developers must have appropriate preliminary data, establishing that programs are past proof-of-concept and early feasibility.
Please contact NIAIDDiagnosticsDevServices@mail.nih.gov to get in touch with staff in the Division of Microbiology and Infectious Diseases (DMID) and discuss the preliminary data required.
Access (Application Process)
How To Get Started
Step 1 – Discuss the potential request informally
Contact NIAIDDiagnosticsDevServices@mail.nih.gov to reach the appropriate DMID staff to discuss your preliminary data and the suitability of your proposed studies for support. Your request will be evaluated as follows:
- Are the proposed studies within the DMID/NIAID mission?
- Are the proposed studies within the scope and capabilities of and/or technology provided by awarded contracts?
- Is the proposed work supported by other funding sources/available from other sources?
- Has the requestor previously used DMID resources for assessment of the same or similar product development service? (Repeat use of DMID resources may be undertaken with strong justification.)
- Are preliminary data adequate to support the request to advance the IVD product to the next step in the product development pathway?
- What is the likelihood that services will contribute significantly to the eventual development and/or regulatory clearance of a product of high quality and commercial sustainability?
- What is the purported public health impact?
- What improvements in health benefits offered beyond current measure(s)?
- Does the requestor have a plan for advancing the product beyond completion of the services requested?
Informal requests are reviewed and approved at the Branch/Office level, where they are considered in relation to Branch/Office priorities.
Step 2 – Submit a formal proposal (by invitation only)
If your proposal is judged to be promising, DMID staff will invite you to submit a formal request for approval through the DMID Preclinical Services for Researchers site. DMID staff will provide instructions for establishing the NIH account required to access this site, instructions for submitting your Request, and a brief description of what to expect next.
Formal requests are reviewed and approved by the DMID senior leadership, where they are considered in relation to Division priorities.
Assurance to Requestors
- A Non-Clinical Evaluation Agreement (NCEA), with an attached Service Request Form (SRF), between NIAID and the requestor shall be required. The NCEA protects the requestor’s intellectual property and ensures confidentiality. The contract establishes confidentiality for all information flowing from NIAID to the contractor. Therefore, additional material transfer agreements between the requestor and the contractor are not needed.
- All information provided to the contractor will be treated as confidential.