Federal Grant Award Summary

Simplusdx, Inc. received a $532,105 Project Grant from the National Cancer Institute under the Cancer Detection and Diagnosis Research Program (CFDA 93.394) beginning July 1, 2026, with completion expected June 30, 2029. The company is developing and validating a point-of-care (POC) screening test for hepatocellular carcinoma (HCC) using its proprietary D4 immunoassay platform. The deliverables include incorporating alpha-fetoprotein-L3 (AFP-L3) into the current biomarker panel, optimizing the POC format for manufacturability and user accessibility, conducting clinical validation through a pilot study at Duke Medical Center, and assessing performance using archived patient samples from diverse populations.

The D4 platform represents a technological advancement over current surveillance methods by enabling multiplexed, high-sensitivity detection of protein biomarkers in whole blood with on-chip reagent storage, eliminating cold-chain requirements for deployment in community and global settings. The project will apply machine learning algorithms to integrate biomarker and clinical data to enhance diagnostic accuracy. This initiative addresses the critical gap in early HCC detection, as standard surveillance tools such as ultrasound and alpha-fetoprotein testing demonstrate limited sensitivity, particularly in patients with cirrhosis, and emerging biomarker panels remain largely unavailable outside tertiary care centers.