Novel Diagnostic Biomarker Discovery and Validation for Malaria and Select Neglected Infectious Diseases
Past New Requirement Updated
- Agency
-
National Institutes of Health
Department of Health and Human Services
- Solicitation expected
- Estimated value
- $1,500,000 to $3,000,000
- Set-aside
- Total Small Business
Forecast facts
- Anticipated award
- NAICS code
- 541715 Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
- Points of contact
Forecast details come from HHS's procurement forecast. Agencies' dates and values are estimates.
About this forecast
The National Institutes of Health is forecasting a new total small business set-aside requirement for a Phase 2 SBIR award to develop novel diagnostic biomarkers, either parasite or host response biomolecules, for malaria and select neglected infectious diseases, with an estimated solicitation release date of September 1, 2026 and an estimated award date of October 1, 2026. Activities may include but are not limited to analytical validation of credentialed candidates, demonstrating prototype performance superior to current assays using clinical samples from diverse cohorts, advanced development of the final prototype platform, scale-up manufacturing with final validation studies, product development strategy for regulatory approval and demonstration of clinical application, and manufacturing process development including Quality Assurance/Quality Control. The work targets the sensitivity and specificity that current diagnostics lack, which elimination programs need to detect all true cases, avoid false negatives, and confirm interruption of transmission.
The posted description caps the Phase 2 award at up to $1.5 million, while the forecast's estimated award value range is $1.5 million to $3.0 million. The forecast is classified under NAICS 541715, Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology), and was posted November 14, 2026, after both estimated dates. Points of contact are Callie Prassinos, Contracting Officer, NIH (callie.prassinos@nih.gov, +1 240-669-5155), and Deirdre Joy, Program Officer, Parasite Genomics, National Institute of Allergy and Infectious Diseases (djoy@niaid.nih.gov).
Forecast text
A Phase 2 SBIR award for up to $1,500,000 to further develop novel malaria or neglected infectious disease diagnostic biomarkers (either parasite or host response biomolecules). As these diseases approach elimination, decreased prevalence and intensity of infection require highly sensitive and specific diagnostics to ensure that all true cases are detected and treated, to avoid false negatives, and to manage the larger volume of samples that must be tested to confirm interruption of transmission. Diagnostics in current use do not meet the sensitivity and/or specificity thresholds required to achieve elimination goals. Activities under this award may include but are not limited to: analytical validation of credentialed candidates; demonstration that prototype performance is superior to assays in current use using clinical samples from diverse cohorts; advanced development of the final prototype platform; scale-up manufacturing of test components and final validation studies; product development strategy for regulatory approval and demonstration of clinical application; process development for manufacturing the diagnostic assay, including Quality Assurance/Quality Control.
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