*Novel Capillary Whole Blood Collection Stakeholder Workshop Series
Forecast New Requirement Updated
- Agency
-
Food and Drug Administration
Department of Health and Human Services
- Solicitation expected
- Estimated value
- $25,000 to $250,000
- Set-aside
- No set-aside
Forecast facts
- Anticipated award
- NAICS code
- Not on record
- Points of contact
-
- CDRH Acquisition Liaison cdhracquisitions@fda.hhs.gov
Forecast details come from HHS's procurement forecast. Agencies' dates and values are estimates.
About this forecast
The Food and Drug Administration is procuring planning and facilitation services for a Novel Capillary Whole Blood Collection Stakeholder Workshop Series, with solicitation release estimated for November 1, 2026, and award targeted for January 1, 2027. The requirement addresses a critical scientific gap: whether capillary blood collected from alternative body sites (such as the arm) produces results equivalent to venous samples across analytes, which is essential to advancing micro-sampling and home self-collection. The workshops will convene blood collection device manufacturers, assay developers, clinical laboratories, academic researchers, and patient representatives to build shared scientific understanding of capillary versus venous sample differences, prioritize analytes and clinical use cases requiring equivalency data, develop consensus on study designs and acceptance criteria, identify actionable steps for stakeholders, and explore collaborative study coordination mechanisms.
The estimated award value ranges from $25,000 to $250,000. FDA/OHT7 plans to convene two to three workshops during fiscal year 2027. Inquiries should be directed to cdhracquisitions@fda.hhs.gov.
Forecast text
Capillary whole blood is a physiologically distinct and complex matrix, consisting of a mixture of arteriolar, capillary, and venular blood combined with variable amounts of interstitial and intracellular fluid. Because of this, biomarker concentrations in capillary blood can differ meaningfully from those in venous blood, which is the most characterized sample for reporting laboratory results. Novel capillary collection devices are being developed targeting alternate collection sites (e.g., arm). However, a critical and unresolved scientific gap exist, as it has not been established that capillary blood collected from the arm (or other body sites beyond the finger) produces results equivalent to venous samples across analytes. This gap is the primary barrier preventing the field of micro-sampling and home self-collection from advancing.Compounding this, are additional technical challenges, including small and variable sample volumes, the need to validate performance across diverse lay users (varying age, literacy, dexterity, and visual acuity), and real-world environmental variables in home settings such as poor lighting, temperature extremes during shipping, and lack of sterile surfaces.FDA/OHT7 proposes to convene 2-3 stakeholder workshops in FY2027 bringing together blood collection device manufacturers, assay developers, clinical laboratories, academic researchers, and patient representatives. The workshops would:Build shared scientific understanding of capillary collected from alternative sites vs. venous sample differencesPrioritize analytes and clinical use cases most in need of equivalency dataDevelop consensus on study designs, statistical approaches, and acceptance criteriaIdentify actionable steps for each stakeholder groupExplore collaborative or multi-site study coordination mechanisms
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