Intelligent Bio Solutions Commences Multi-Site Method Comparison Study for FDA 510(k) Submission

Intelligent Bio Solutions Inc. launched a multi-site study to validate its Intelligent Fingerprinting Drug Screening System for FDA 510(k) clearance, testing accuracy and ease of use by workplace personnel across 135 participants. The study, conducted with CenExel Clinical Research, aims to demonstrate real-world performance for detecting codeine and other drugs, with results expected by July 2026 to support regulatory submission." "article": "Intelligent Bio Solutions Inc. (Nasdaq: INBS) has begun a multi-site Method Comparison Study to support its FDA 510(k) submission for U.S. market clearance of its Intelligent Fingerprinting Drug Screening System, specifically for detecting the opiate codeine. The study, conducted in partnership with CenExel Clinical Research, will evaluate the system’s accuracy when operated by typical workplace drug screening personnel across nine clinical sites. A total of 135 participants will be enrolled and randomized into dosing groups, reflecting the demographic diversity of the U.S. population, with fingerprint sweat specimens collected and analyzed. The study focuses on demonstrating the system’s ease of use, a key competitive advantage, as it aims to show that non-laboratory-trained personnel can operate it effectively in real-world workplace screening environments. Key performance metrics, including sensitivity, specificity, and overall accuracy, will be assessed and independently confirmed using liquid chromatography-tandem mass spectrometry (LC-MS/MS), the gold standard for drug detection. The study aligns with International Council for Harmonisation Good Clinical Practice (ICH GCP) Guidelines and national regulatory requirements, ensuring robust data collection across diverse settings. Intelligent Bio Solutions expects to complete enrollment and data collection by the end of July 2026, with results included in its FDA submission alongside data from a previously announced clinical cut-off study that began in January 2026. The Intelligent Fingerprinting Drug Screening System uses fingerprint sweat analysis to detect recent drug use, including opiates, cocaine, methamphetamine, and cannabis. The system is designed for rapid, non-invasive testing, providing results in under ten minutes with sample collection in seconds, making it ideal for safety-critical industries. The company’s goal is to position the system as a reliable, cost-effective tool for workplace drug screening in the U.S. market.