Innovative Screening Approaches and Therapies for Screenable Disorders in Newborns (R21 - Clinical Trial Optional)
Develop new screening methods and treatments for newborns with potentially fatal or disabling disorders identified through newborn screening, focusing on high priority genetic conditions with potential for future screening.
Funder: National Institutes of Health
Due Dates: June 16, 2025 (New) | July 16, 2025 (Renewal/Resubmission/Revision) | October 16, 2025 (New) | November 16, 2025 (Renewal/Resubmission/Revision) | February 16, 2026 (New) | March 16, 2026 (Renewal/Resubmission/Revision) | June 16, 2026 (New) | July 16, 2026 (Renewal/Resubmission/Revision) | October 16, 2026 (New) | November 16, 2026 (Renewal/Resubmission/Revision) | February 16, 2027 (New) | March 16, 2027 (Renewal/Resubmission/Revision) | June 16, 2027 (New) | July 16, 2027 (Renewal/Resubmission/Revision) | October 16, 2027 (New) | November 16, 2027 (Renewal/Resubmission/Revision)
Funding Amounts: Up to $275,000 direct costs over 2 years; no more than $200,000 in any single year; project period up to 2 years.
Summary: Supports exploratory research to develop innovative screening methods and therapies for newborns with fatal or disabling disorders, including high-priority genetic conditions not yet on screening panels.
Key Information: Clinical trials are optional; foreign and domestic applicants are eligible; Data Management and Sharing Plan required.
Description
This NIH opportunity (R21 mechanism) encourages exploratory and developmental research on novel screening approaches and/or therapeutic interventions for conditions identified through newborn screening, as well as for "high priority" genetic conditions that could benefit from early detection but are not yet included in standard newborn screening panels. The goal is to advance the science of early identification and intervention for potentially fatal or disabling disorders in newborns, ultimately improving health outcomes and informing future screening panel recommendations.
Research may address:
- Development, optimization, or validation of new screening technologies or assays
- Adaptation of existing screening methods for broader or low-resource use
- Use of AI or computational modeling to improve screening accuracy
- Preclinical or clinical studies of new or optimized therapies
- Comparative effectiveness of interventions
- Studies on health systems, access, and outcomes for affected infants
- Ethical, legal, and social implications of new screening or treatment approaches
Both basic and clinical research, including clinical trials, are supported.
