NEW YORK, New York — August 5, 2026 — Leads & Copy — Intelligent Bio Solutions Inc. (Nasdaq: INBS), a medical technology company that provides rapid, non-invasive testing solutions, announced the successful completion of its Usability Study for the Intelligent Fingerprinting Drug Screening System. This milestone supports the company’s U.S. Food and Drug Administration (FDA) 510(k) submission for market clearance to detect the opiate codeine. The study was conducted in collaboration with CenExel Clinical Research, Inc., adhering to FDA guidelines and International Council for Harmonisation Good Clinical Practice (ICH GCP) standards.
The research aimed to assess how effectively operators could be trained to use the Intelligent Fingerprinting Drug Screening System and gauge its ease of use in a workplace environment. Fifteen operators without the need for specialist laboratory knowledge or prior experience with the system participated. Peter Passaris, Vice President of Product Development at Intelligent Bio Solutions, stated that employers prefer simple and reliable drug testing processes, and the study’s outcome confirms that the system can be accurately operated by individuals without a specialized background.
The Usability Study is a component of the company’s comprehensive FDA 510(k) submission program, which also includes a Cut-off Study, Method Comparison Study, Interference Study, precision testing, and penetration testing. Intelligent Bio Solutions is on schedule to submit its 510(k) package in the second half of 2026, as it prepares to enter the multi-billion-dollar U.S. drug screening market. The Intelligent Fingerprinting Drug Screening System utilizes fingerprint sweat analysis for drug detection, aiming to revolutionize portable testing with potential applications in various fields. The system is designed to be hygienic and cost-effective, screening for the recent use of drugs commonly found in the workplace, including opiates, cocaine, methamphetamine, and cannabis. With sample collection in seconds and results available in under ten minutes, the technology is positioned as a valuable tool for employers in safety-critical industries. Current international customer segments include construction, manufacturing and engineering, transport and logistics firms, mining, drug treatment organizations, and coroners.
Source: Intelligent Bio Solutions Inc.
