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Intelligent Bio Solutions Initiates Additional Clinical Studies for FDA 510(k) Submission Supporting Planned Entry into Multi-Billion Dollar U.S. Market
Globenewswire· 2026-01-28 13:30
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]
Intelligent Bio Solutions to Participate in Noble Capital Markets' 21st Annual Emerging Growth Equity Conference on December 2-3, 2025
Newsfile· 2025-11-20 13:30
Core Insights - Intelligent Bio Solutions Inc. will participate in the 21st Annual Emerging Growth Equity Conference hosted by Noble Capital Markets on December 2-3, 2025 [1] Company Overview - Intelligent Bio Solutions Inc. is a medical technology company focused on delivering intelligent, rapid, non-invasive testing solutions [4] - The company’s Intelligent Fingerprinting Drug Screening System utilizes fingerprint sweat analysis, aiming to revolutionize portable testing with potential applications in various fields [4] - The system is designed to be hygienic and cost-effective, screening for recent drug use, including opiates, cocaine, methamphetamine, and cannabis, with results available in under ten minutes [4] - Current customer segments outside the U.S. include construction, manufacturing, engineering, transport and logistics, mining, drug treatment organizations, and coroners [4] Conference Details - The conference will take place at Florida Atlantic University, Boca Raton, FL, with Intelligent Bio Solutions scheduled to present on December 3, 2025, at 11:00 a.m. Eastern Time [2] - A webcast recording of the presentation will be available on the company's investor relations website and Noble's website for 90 days post-event [2]