Core Insights - Intelligent Bio Solutions Inc. has initiated a clinical study program to support its FDA 510(k) submission for the Intelligent Fingerprinting Drug Screening System, aimed at detecting the opiate codeine [1][5] - The U.S. drug screening market presents a significant commercial opportunity, generating several billion dollars annually across various sectors [4] Company Overview - Intelligent Bio Solutions Inc. specializes in intelligent, rapid, non-invasive testing solutions, with a focus on fingerprint-based drug screening technology [6] - The Intelligent Fingerprinting Drug Screening System is designed to be hygienic, cost-effective, and capable of providing results in under ten minutes, making it suitable for safety-critical industries [6] Clinical Study Details - The first clinical study will involve 40 adults and will assess codeine detection cut-off levels using the Intelligent Fingerprinting Drug Screening Cartridge and DSR-Plus fluorescence reader [3] - The study will compare results with an FDA-cleared device and will utilize liquid chromatography-tandem mass spectrometry (LC-MS/MS) for corroboration [3] Market Potential - The U.S. drug screening market is the largest globally, with applications in workplace testing, criminal justice, pain management, and substance abuse treatment [4] - The company's technology offers advantages over traditional testing methods, including improved hygiene, ease of use, rapid results, and reduced collection costs [4] Strategic Partnerships - The company has partnered with Cliantha Research, a clinical research organization, to leverage its expertise in regulatory and clinical trials [2] - Subject recruiting and screening for the clinical study have already begun, with the first testing cohort starting on January 28, 2026 [5]