SBIR: Development of Novel Diagnostics for Celiac Disease
Forecast New Requirement Updated
- Agency
-
National Institutes of Health
Department of Health and Human Services
- Solicitation expected
- Estimated value
- Not on record
- 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
NIH is forecasting a new requirement for an SBIR effort to develop novel celiac disease diagnostic tests, set aside for total small business under NAICS 541715, with estimated solicitation release on 2027-05-01 and estimated award on 2028-02-01. The tests must diagnose celiac disease without gastrointestinal endoscopy and biopsy or a gluten-containing diet, and must be superior to currently available tests. The stated focus populations are young children, patients on a gluten-free diet, patients with mild or asymptomatic disease, and patients who are non-responsive or refractory to a gluten-free diet.
Contracting Officer Callie Prassinos (NIH, callie.prassinos@nih.gov, +12406695155) is the contracting point of contact, and Program Officer Jeffrey Rice (National Institutes of Health, ricejs@niaid.nih.gov) is the program point of contact. The forecast was posted on 2026-11-14.
Forecast text
The goal of this program is to support the development of novel diagnostics for celiac disease for clinical use. Celiac disease is an autoimmune disease in genetically susceptible individuals in which an immune response to dietary gluten damages the small intestine. Diagnosis is challenging because patients can have a broad range of gastrointestinal and extraintestinal symptoms, current serological tests have limitations in some patients, and confirmation may require gastrointestinal endoscopy with duodenal biopsy. Diagnosis can be particularly difficult in young children, patients on a gluten-free diet, patients with mild or asymptomatic disease, and patients who are non-responsive or refractory to a gluten-free diet. Current diagnostic approaches may also require a gluten-containing diet or gluten challenge, and endoscopy and biopsy are not practical for some patients. There is a critical need for diagnostic tests that can accurately diagnose celiac disease without requiring gastrointestinal endoscopy and biopsy or a gluten-containing diet and that can identify celiac disease in difficult-to-diagnose populations. The services needed are the development of novel diagnostic tests for celiac disease that do not require gastrointestinal endoscopy and are superior to currently available tests.
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