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Intelligent Bio Solutions Completes Drug Screening Study
Intelligent Bio Solutions announced the completion of its multi-site Method Comparison Study for the Intelligent Fingerprinting Drug Screening System, one of several studies underpinning the company's FDA 510(k) submission for U.S. market clearance for detection of the opiate codeine. All clinical data collection across the company's FDA 510(k) clinical study program is now complete. The study was conducted across three independent U.S. clinical sites over three weeks in partnership with CenExel Clinical Research. A total of 135 participants were enrolled. The company now moves into analysis, compilation, and finalization of its 510(k) submission package, targeting submission in the second half of 2026, ahead of planned entry into the multi-billion-dollar U.S. market.
Intelligent Bio Solutions Completes Precision Testing
Intelligent Bio Solutions announced the completion of precision testing, a key component of the company's FDA 510 submission for U.S. market clearance of its Intelligent Fingerprinting Drug Screening System for detection of the opiate codeine. The precision testing, conducted following the Company's clinical cut-off adjustment, confirmed that the Intelligent Fingerprinting Drug Screening System produced consistent, reliable results across varied manufacturing conditions and operating environments. The precision testing included more than 1,600 tests across three production runs and three independent sites. The results showed repeatable, reproducible performance across all runs and sites, confirming the system's suitability for workplace and other drug screening environments.
Intelligent Bio Solutions Initiates Multi-Site Study for FDA Submission
Intelligent Bio Solutions announced the initiation of a multi-site method comparison study to support its FDA 510 submission for U.S. market clearance of its Intelligent Fingerprinting Drug Screening System for the opiate codeine. The company has partnered with nationwide clinical research site network, CenExel Clinical Research, Inc., to perform the study, which will evaluate the accuracy of the Intelligent Fingerprinting Drug Screening System when operated by intended end-users across multiple clinical sites. A total of 135 donor participants will be enrolled and randomized into dosing groups, with demographics designed to reflect the diversity of the U.S. population. Fingerprint sweat specimens will be collected and analyzed by nine operator participants representing typical workplace drug screening personnel.
Intelligent Bio Solutions Launches Validation Study for Drug Screening System
Intelligent Bio Solutions announced the launch of a validation study aimed at significantly reducing the analysis time of its Intelligent Fingerprinting Drug Screening System, IFDSS. The study aims to improve the already rapid time-to-result of INBS's drug screening technology, which collects samples in under a minute and provides results within ten minutes at the point of collection. Faster results will enable INBS to target the global roadside drug testing market with a first-in-class solution. "Speed matters in drug screening and is critical for roadside law enforcement," said Harry Simeonidis, President and CEO at INBS. "Moving from a ten-minute test to under three minutes changes the entire value equation for our customers. This validation study aims to confirm our encouraging preliminary findings and advance us toward our two-minute test goal."
Intelligent Bio Solutions Completes Penetration Testing, Enhances FDA Submission
Intelligent Bio Solutions announced the successful completion of penetration testing as part of its upcoming FDA 510(k) submission. The testing identified no major vulnerabilities, verified the robustness of the Company's existing security infrastructure, and strengthened its regulatory submission to the FDA. In conjunction with the penetration testing, INBS implemented additional security upgrades to its drug testing technology. These upgrades include enhanced encrypted identification tags to ensure test integrity and improved firmware safeguards that allow only authorized updates and protect against cyber threats. "Successful completion of penetration testing is another key milestone in our FDA 510(k) submission process. This independent assessment identified no major security vulnerabilities, confirming the effectiveness of our security approach," said Harry Simeonidis, President and CEO at INBS. "These new upgrades reflect our commitment to protecting donor data and implementing security measures that meet and exceed regulatory expectations, bolstering our upcoming 510(k) submission to the FDA."
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