Project Grant R44DK148331

The National Institute of Diabetes and Digestive and Kidney Diseases awarded Pupil Bio, Inc. $1,015,056 on September 1, 2026, under the Diabetes, Digestive, and Kidney Diseases Extramural Research program (CFDA 93.847) to develop an early detection test for Type 1 Diabetes using next-generation sequencing analysis of B cell-specific methylation patterns in cell-free DNA.

Pupil Bio will refine marker selection to identify methylation patterns ultra-specific to pancreatic islet B cells, building on Phase I work that validated a 50-plex amplicon-based panel and identified over 357,000 candidate ultra-specific phased methylation patterns with 100 percent specificity to pancreatic islets. The company has developed a proprietary DIMPLE algorithm for highly multiplexed primer design in methylation sequencing applications and optimized amplicon-based workflows to minimize sample loss compared to traditional hybrid capture methods. The test aims to enable detection of B cell death during asymptomatic stages of Type 1 Diabetes, allowing early intervention with therapies such as teplizumab before 80 percent or more of insulin-producing B cells are destroyed.

Performance occurs in Houston, Texas. The period of performance runs from September 1, 2026, through August 31, 2028. The assistance type is a Project Grant, a Phase II SBIR award evaluated on the degree to which Phase I objectives were met and the scientific and technical merit, technological innovation, and commercial potential of the proposed Phase II work.