NEW YORK, July 21, 2026
Intelligent Bio Solutions Inc. announced the successful completion of precision testing, an important milestone supporting its planned FDA 510(k) submission for the Intelligent Fingerprinting Drug Screening System, which is designed to detect codeine using a non-invasive fingerprint sweat sample. The precision testing program evaluated the system through more than 1,600 individual tests, conducted across three manufacturing production runs and three independent testing sites, demonstrating highly repeatable and reproducible performance under varied operating conditions. The results strengthen the company’s regulatory package as it prepares for planned entry into the multi-billion-dollar U.S. drug screening market, where rapid, portable, and hygienic testing technologies continue to gain significant demand across workplace safety, healthcare, and law enforcement applications.
Precision Testing Demonstrates Reliable Performance Across Multiple Sites
The completed precision testing followed the company’s previously announced clinical cut-off adjustment and confirmed that the Intelligent Fingerprinting Drug Screening System consistently delivered accurate and reproducible results regardless of manufacturing variations or testing environments. According to the company, the comprehensive evaluation included testing across multiple production batches and independent laboratories to verify the system’s suitability for real-world workplace drug screening and other routine testing applications. The precision data will become a key component of the company’s FDA 510(k) submission, providing evidence that the technology maintains dependable analytical performance while supporting rapid, point-of-care drug detection using fingerprint sweat rather than conventional biological samples.
Comprehensive FDA Submission Package Continues to Expand
The newly completed precision study complements several other regulatory studies already completed by Intelligent Bio Solutions, including its Cut-off Study, Method Comparison Study, Interference Study, and penetration testing. Together, these studies provide supporting evidence covering accuracy, precision, specificity, usability, safety, and cybersecurity, helping build a comprehensive FDA submission package for U.S. regulatory review. Company President and CEO Harry Simeonidis stated that each completed study strengthens the scientific evidence supporting the FDA application while bringing the company closer to commercial launch in the United States once regulatory clearance is obtained.
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Fingerprint Drug Screening Targets Expanding U.S. Testing Market
The Intelligent Fingerprinting Drug Screening System is designed to offer a faster, cleaner, and more convenient alternative to traditional urine, oral fluid, and blood-based drug testing. The portable system collects a fingerprint sweat sample within seconds and provides results in less than 10 minutes, allowing organizations to perform drug screening virtually anywhere without invasive sample collection procedures. Initially targeting workplace safety, the technology also has potential applications in criminal justice, pain management, substance abuse treatment, transportation, construction, manufacturing, mining, and logistics industries. With growing demand for rapid and non-invasive screening solutions, Intelligent Bio Solutions believes successful FDA 510(k) clearance will position the company to compete in one of the world’s largest drug testing markets while expanding adoption of fingerprint-based diagnostics across multiple sectors.
Source: Intelligent Bio Solutions press release
