Precision Diabetes

Executive Summary

Precision Diabetes, Inc. is a San Diego-based diagnostics company pioneering precision medicine in diabetes with its exclusive GlycoMark test (1,5-Anhydroglucitol). This FDA-cleared and CE-marked blood test uniquely detects recent hyperglycemia, glycemic variability, and pancreatic beta-cell mass, addressing a critical gap in diabetes management. As the sole supplier in the U.S., Europe, Australia, Asia-Pacific, the Middle East, and Mexico, the company has established a strong commercial foothold. The test enables clinicians to optimize therapy, monitor short-term glucose fluctuations not captured by HbA1c, and assess beta-cell function, supporting personalized treatment regimens. With rising global diabetes prevalence and growing emphasis on glycemic variability as a complication risk factor, Precision Diabetes is well-positioned to capture market share. The company’s focus on a novel biomarker and proprietary algorithms differentiates it from traditional glucose monitoring tools. While still private and early-stage, its regulatory clearances and exclusive distribution rights provide a defensible position. Future growth hinges on expanding adoption among endocrinologists and payers, as well as integrating the test into digital health platforms and clinical trial endpoints. The company’s technology could also serve as a companion diagnostic for emerging therapies targeting beta-cell preservation. Overall, Precision Diabetes represents a niche but high-impact opportunity in the evolving precision medicine landscape for diabetes.

Upcoming Catalysts (preview)

• Q4 2026New Medicare Coverage Decision or Private Payer Reimbursement for GlycoMark60% success
• Q2 2026Strategic Partnership with a Major Diabetes Pharmaceutical Company for Trial Use50% success
• Q3 2026Publication of Key Clinical Study Demonstrating GlycoMark’s Utility in Predicting Diabetes Complications70% success