NEW YORK, June 16, 2026
Intelligent Bio Solutions (INBS) announced the initiation of a critical clinical Interference Study designed to support its planned FDA 510(k) submission for the U.S. market clearance of the company’s Intelligent Fingerprinting Drug Screening System for the detection of codeine. The study represents another important milestone in the company’s regulatory strategy as it advances a rapid, non-invasive drug testing platform based on fingerprint sweat analysis. Conducted in partnership with CenExel Clinical Research, the study is expected to strengthen the clinical evidence package supporting FDA review while helping position the technology for future commercialization in the United States.
Study Designed to Demonstrate Accuracy in Real-World Conditions
The Interference Study will enroll 75 healthy adult participants and evaluate the performance of the Intelligent Fingerprinting Drug Screening System under both dosed and undosed conditions. Participants will handle various substances commonly encountered in daily life that could potentially interfere with test results before undergoing screening. The objective is to demonstrate that the system can accurately identify codeine use while maintaining specificity and reliability despite exposure to external substances. Interference testing is a key FDA requirement for diagnostic devices because it helps confirm that a test can distinguish the target analyte from environmental contaminants, reducing the risk of false-positive or false-negative outcomes. Such validation is particularly important in workplace drug testing programs where inaccurate results may have significant professional and legal consequences.
Comprehensive Clinical Program Supports FDA 510(k) Submission
The Interference Study forms part of a broader FDA-focused clinical development program that also includes an ongoing Method Comparison Study and a previously initiated Cut-off Study, which began in January 2026. Together, these studies are designed to generate comprehensive evidence demonstrating the system’s accuracy, safety, specificity, usability, and overall performance. Study samples will be analyzed and confirmed using liquid chromatography-tandem mass spectrometry (LC-MS/MS), a highly sensitive laboratory method widely recognized as a gold standard for toxicology testing. The protocol includes multiple collection time points to evaluate device performance across a range of real-world testing scenarios and support robust clinical validation.
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Fingerprint Sweat Analysis Offers Rapid Non-Invasive Drug Detection
The Intelligent Fingerprinting Drug Screening System utilizes fingerprint sweat analysis to detect recent drug use without the need for blood, urine, or saliva collection. The technology is designed to provide a hygienic, convenient, and cost-effective alternative to traditional drug testing methods, with sample collection completed in seconds and results available in less than ten minutes. Beyond codeine detection, the platform is capable of screening for several substances commonly encountered in workplace environments, including opiates, cocaine, methamphetamine, and cannabis. Intelligent Bio Solutions believes the technology has the potential to transform drug screening practices across industries such as construction, transportation, logistics, manufacturing, mining, and healthcare. The company expects to complete the Interference Study by mid-July 2026 and plans to include the resulting data in its FDA 510(k) submission package as it moves closer to potential U.S. regulatory clearance and commercial market entry.
Source: Intelligent Bio Solutions press release
