Study designed to validate accuracy and real-world workplace performance of the Intelligent Fingerprinting Drug Screening System 

Company expects to complete enrollment and data collection by the end of July, 2026
 

NEW YORK, June 02, 2026 (GLOBE NEWSWIRE) -- Intelligent Bio Solutions Inc. (NASDAQ:INBS) ("INBS" or the "Company"), a medical technology company delivering intelligent, rapid, non-invasive testing solutions, today announced the initiation of 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 for the opiate codeine.

The Company has partnered with nationwide clinical research site network, CenExel Clinical Research, Inc., to perform the study, which will evaluate the accuracy of the Intelligent Fingerprinting Drug Screening System when operated by intended end-users across multiple clinical sites. A total of 135 donor participants will be enrolled and randomized into dosing groups, with demographics designed to reflect the diversity of the U.S. population. Fingerprint sweat specimens will be collected and analyzed by nine operator participants representing typical workplace drug screening personnel. The study is designed to demonstrate the system's real-world performance when used by personnel who may not have specialized laboratory training.

User performance evaluation is a key part of the Company's FDA 510(k) submission. It is designed to show that typical users in occupational health, HR, and workplace safety can operate the Intelligent Fingerprinting Drug Screening System accurately and effectively in real pre-employment and workplace screening environments.

The study will assess key performance metrics, including the system's sensitivity, specificity, and overall accuracy. Results will be independently confirmed via liquid chromatography-tandem mass spectrometry ("LC-MS/MS") analysis, the gold standard method for drug detection confirmation.

The study will be conducted across multiple sites in accordance with ICH GCP (International Council for Harmonisation Good Clinical Practice) Guidelines and national regulatory requirements, enhancing data robustness across diverse operating environments and user populations.

The Company expects to complete enrollment and data collection by the end of July 2026. Results will be included in its FDA 510(k) submission package. These results will appear alongside data from the previously announced clinical cut-off study which began in January 2026.