Intelligent Bio Solutions Inc. (NASDAQ: INBS) announced the completion of a multi-site Method Comparison Study for its Intelligent Fingerprinting Drug Screening System, concluding all clinical data collection under the company's FDA 510(k) clinical study program.

The study was conducted across three independent U.S. clinical sites over three weeks, following ICH GCP guidelines, in partnership with CenExel Clinical Research, Inc. A total of 135 participants were enrolled, with the study population structured to reflect U.S. demographic diversity. Nine operator participants representing typical workplace drug screening personnel administered the screening process.

The study was designed to evaluate whether users in occupational health, human resources, and workplace safety settings can operate the system accurately in the field, measuring sensitivity, specificity, and accuracy in pre-employment and workplace screening environments. All specimens will be independently verified using liquid chromatography-tandem mass spectrometry analysis, which is currently underway.

The FDA 510(k) submission seeks U.S. market clearance for detection of the opiate codeine. The company said it is targeting submission in the second half of 2026.

"We are now firmly in the final stretch of data analysis and assembly of our FDA 510(k) submission package, and we remain focused on bringing our technology to the U.S. market," said Harry Simeonidis, President and CEO of Intelligent Bio Solutions.

The company said it will now move into analysis, compilation, and finalization of its 510(k) submission package. Outside the U.S., the company's current customers include businesses in construction, manufacturing, transport, logistics, mining, and drug treatment organizations.