New York, August 3, 2026
Intelligent Bio Solutions Inc. (INBS) announced the completion of an Interference Study for its Intelligent Fingerprinting Drug Screening System, marking another milestone toward the company’s planned U.S. Food and Drug Administration (FDA) 510(k) submission. The study evaluated whether substances commonly encountered in everyday life and workplace environments could affect the accuracy and reliability of the fingerprint-based testing technology. The work supports INBS’s regulatory submission for U.S. market clearance of the system for detection of the opiate codeine, with the company remaining on track to submit its FDA 510(k) package during the second half of 2026.
Interference Study Evaluates Real-World Testing Conditions
The study was conducted with CenExel Clinical Research, Inc. and followed FDA guidance and International Council for Harmonisation Good Clinical Practice (ICH GCP) Guidelines. It was specifically designed to assess whether external contaminants present on a person’s fingertip could interfere with the performance of the Intelligent Fingerprinting Drug Screening System. Researchers evaluated a range of substances commonly encountered in daily life and workplace environments, including hand creams, alcohol-based products, oils, dirt and water. The objective was to determine whether exposure to these materials could influence test results and to assess the system’s ability to maintain codeine specificity across multiple collection time points. With the study now complete, data analysis is underway, and results are being independently verified using liquid chromatography-tandem mass spectrometry (LC-MS/MS). Because the fingerprint testing system is designed for use outside traditional laboratory environments, evaluating its performance under realistic field conditions represents an important component of establishing its reliability and suitability for intended use.
FDA 510(k) Program Builds Evidence for Fingerprint Drug Screening
The Interference Study forms part of a broader validation program designed to support Intelligent Bio Solutions’ FDA 510(k) submission. The regulatory program has included a clinical Cut-off Study, Method Comparison Study, precision testing and penetration testing, alongside the newly completed interference evaluation. Collectively, these studies are intended to address key aspects of the system’s safety, accuracy, usability, specificity and precision. Intelligent Bio Solutions said completion of the Interference Study keeps the company on track as it moves into the data-analysis phase and continues assembling its regulatory submission package. The company currently plans to submit the complete 510(k) package in calendar H2 2026 as it works toward potential entry into the U.S. drug-screening market. The system has not yet received the FDA clearance sought through this regulatory program, making completion and analysis of the supporting validation studies important steps before potential U.S. commercialization.
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Fingerprint Sweat Technology Enables Rapid Non-Invasive Testing
The Intelligent Fingerprinting Drug Screening System uses fingerprint sweat analysis to screen for recent drug use, offering a rapid and non-invasive approach to sample collection. According to Intelligent Bio Solutions, fingerprint samples can be collected within seconds, with test results available in under 10 minutes. The technology is designed as a hygienic and cost-effective portable testing solution and currently screens for drugs commonly encountered in workplace testing, including opiates, cocaine, methamphetamine and cannabis in markets where it is offered. The company sees potential applications particularly within safety-critical industries where rapid drug screening can support workplace testing programs. Current customer segments outside the United States include construction, manufacturing and engineering, transportation and logistics, mining, drug treatment organizations and coroners. Intelligent Bio Solutions believes fingerprint sweat analysis could ultimately have applications beyond its current drug-screening focus. For the U.S. program, however, the immediate regulatory objective centers on codeine detection and the planned FDA 510(k) submission. Completion of the Interference Study adds another component to the evidence package intended to demonstrate that the technology can provide reliable results even when fingerprints encounter substances commonly present in real-world environments. As INBS moves through data analysis and independent LC-MS/MS verification, the results will help determine whether the system meets the performance requirements necessary to support its planned U.S. regulatory submission and potential entry into the American drug-screening market.
Source: Intelligent Bio press release
