NEW YORK, August 11, 2026
Intelligent Bio Solutions Inc. announced the completion of its multi-site Method Comparison Study for the Intelligent Fingerprinting Drug Screening System, marking the completion of clinical data collection across the company’s FDA 510(k) clinical study program. The study is part of the evidence supporting a planned U.S. market clearance submission for detection of the opiate codeine. Conducted across three independent U.S. clinical sites in collaboration with CenExel Clinical Research, the study enrolled 135 participants over three weeks and included nine operators representing typical workplace drug-screening personnel. The company said the study was designed to evaluate whether users in occupational health, human resources and workplace safety settings could operate the system accurately and effectively in real-world screening environments
Method Comparison Study Evaluates Accuracy and Usability
The study evaluated the Intelligent Fingerprinting Drug Screening System across key performance measures including sensitivity, specificity and accuracy in pre-employment and workplace drug-screening settings. The protocol followed International Council for Harmonisation Good Clinical Practice (ICH GCP) guidelines, with the participant population structured to reflect the demographic diversity of the U.S. population. All collected specimens are expected to undergo independent verification using liquid chromatography-tandem mass spectrometry (LC-MS/MS). According to Intelligent Bio Solutions, the study represents an operationally important component of the company’s FDA submission because it evaluates system performance using operators who reflect typical workplace screening personnel rather than relying solely on laboratory-based testing..
FDA 510(k) Submission Remains on Track
With clinical data collection now complete, Intelligent Bio Solutions is moving into data analysis, clinical evidence compilation and finalization of its FDA 510(k) submission package. The company continues to target submission during the second half of 2026. Completion of the Method Comparison Study follows a broader clinical program intended to address requirements related to safety, accuracy, usability, specificity and precision. Importantly, completion of the studies does not mean FDA clearance has been granted; the company must still submit its complete 510(k) package and undergo FDA review before the product can be marketed in the United States.
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Fingerprint Sweat Testing Targets Workplace Drug Screening
The Intelligent Fingerprinting Drug Screening System uses fingerprint sweat analysis to provide a rapid, non-invasive approach to drug screening. The platform is designed to detect recent use of commonly screened substances, including opiates, cocaine, methamphetamine and cannabis, with sample collection reportedly taking seconds and results available in less than ten minutes. Intelligent Bio Solutions currently serves customers outside the United States across sectors including construction, manufacturing, engineering, transportation, logistics, mining, drug treatment organizations and coroners. Successful FDA clearance could expand the company’s access to the U.S. workplace drug-testing market, but the timing and outcome of regulatory review remain subject to FDA determination.
Source:Intelligent Bio Solutions press release
