Intelligent Bio Solutions Starts Clinical Program For FDA Clearance Of Codeine Test, Launches Trials With Cliantha To Support U.S. Market Clearance

Intelligent Bio Solutions Inc. announced the launch of a new clinical study program aimed at supporting a fresh FDA 510(k) submission for U.S. clearance of its Intelligent Fingerprinting Drug Screening System for detecting the opiate codeine. The program is designed to expand the company’s regulatory footprint in the U.S. and move its technology beyond the forensic-use-only category into broader commercial applications.

The company is again working with clinical research organization Cliantha Research, drawing on its regulatory and trial management expertise. The first study will enroll 40 adults at a single site and focus on establishing appropriate detection cut-off levels for codeine using the Intelligent Fingerprinting Drug Screening Cartridge together with the DSR-Plus fluorescence reader. Participants will receive controlled doses of codeine, and samples will be analyzed to verify optimal thresholds.

“Obtaining FDA clearance for the U.S. market is a major opportunity for Intelligent Bio Solutions,” said Harry Simeonidis, President and CEO at Intelligent Bio Solutions. “The U.S. drug screening market is the largest and most sophisticated in the world, and our Intelligent Fingerprinting technology is uniquely positioned to address unmet needs across multiple high-value segments, including workplace testing, clinical settings, and law enforcement applications. Initiating our clinical studies marks a pivotal moment for our company and the customers we aim to serve. This milestone reflects years of rigorous scientific development and dedication from our team. It will further demonstrate the proven performance of our technology, with over 500,000 tests already sold and used outside the U.S. We look forward to completing these trials and compiling the results as part of our overall FDA submission.” 

The study includes direct performance comparisons with an FDA-cleared predicate device to align with the 510(k) regulatory pathway, and results will also be confirmed using liquid chromatography-tandem mass spectrometry (LC-MS/MS). INBS said this approach is intended to strengthen both its regulatory submission and its commercial strategy for entering the large U.S. drug-testing market.

Recruitment has already begun, with the first cohort scheduled to start testing on January 28, 2026, and full data analysis expected by the end of March 2026. The company plans to incorporate the findings into its upcoming FDA filing, positioning its fingerprint-based, non-invasive testing technology, which promises faster results, improved hygiene, and lower collection costs, as an alternative to urine, blood, and oral fluid testing.