Simplusdx, Inc.

Development and Validation of a Point-of-need Screening Test for Hepatocellular Carcinoma - Project Summary Hepatocellular Carcinoma (HCC) Is a Leading Cause of Cancer-related Death Globally and the Fastest-rising Cause of Cancer Mortality in the United States. Although Curative Therapies Are Effective When HCC Is Detected Early, Most Cases Are Diagnosed at Advanced Stages Due to Inadequate Surveillance and the Lack of Accessible Diagnostic Tools. Standard Surveillance Methods—such as Ultrasound and Alpha-fetoprotein (AFP) Testing—have Limited Sensitivity for Early-stage Disease, Especially in Patients With Cirrhosis. Emerging Biomarker Panels Like the Galad Score, Which Incorporates Sex, Age, Afp, AFP-L3, and Des-gamma-carboxy Prothrombin (DCP), Offer Improved Performance But Are Largely Unavailable Outside of Tertiary Care Centers. to Address These Unmet Needs, We Propose to Finalize Development and Clinically Translate a Point-of-care (POC) Surveillance Test for HCC Using the D4 Immunoassay Platform. Built on a Nonfouling Poly(oligoethylene Glycol Methyl Ether Methacrylate) (POEGMA) Brush, the D4 Enables Multiplexed, High-sensitivity Detection of Protein Biomarkers in Whole Blood, With All Reagents Stably Stored On-chip—eliminating the Need for Cold-chain Logistics and Facilitating Deployment in Both Community and Global Settings. the D4 Platform Has Been Previously Validated Across Multiple Disease Areas, Including Infectious Disease and Cancer. in This Project, We Will: (1) Incorporate AFP-L3 Into the Current Biomarker Panel to Enhance Sensitivity and Specificity; (2) Optimize the Poc Format for Manufacturability, Reproducibility, and Ease of Use; (3) Gather Clinical Feedback Through a Pilot Study at Duke Medical Center; and (4) Assess Clinical Performance Using Archived Patient Samples From Diverse Populations. Finally, We Will Apply Machine Learning Algorithms to Integrate Biomarker and Clinical Data (e.g., Age, Sex, Liver Disease History) to Improve Diagnostic Accuracy and Risk Stratification. This Effort Represents a Close Academic- Industry Collaboration Between Duke University and Simplusdx, a Diagnostics Company Dedicated to Simplifying Complex Testing. the Resulting Assay Will Support Decentralized HCC Screening, Facilitate Earlier Detection, and Expand Access to Curative Interventions—particularly in Underserved and Low-resource Settings—helping to Close a Critical Public Health Gap.