Intelligent Bio completes initial drug screening system clinical cut-off study

Intelligent Bio Solutions (INBS) announced the successful completion of its initial clinical cut-off study supporting the company’s FDA 510(k) submission for U.S. market clearance of its Intelligent Fingerprinting Drug Screening System for detection of the opiate codeine. The clinical cut-off study evaluated codeine detection cut-off levels in 40 adults, with full data analysis completed as planned by the end of March. The study used the Intelligent Fingerprinting Drug Screening Cartridge with the DSR-Plus fluorescence reader, compared results with an FDA-cleared predicate device, and confirmed findings through liquid chromatography-tandem mass spectrometry analysis. INBS has now initiated the second phase of its clinical study program. This includes a multi-site Method Comparison and Usability Study. This study is designed to validate the system’s accuracy, usability, and workplace performance when operated by intended end users at several clinical sites. The company expects to complete the method comparison and usability study by the end of June. In parallel with the method comparison and usability study, the company will be commencing an Interference study, which will test the device in the presence of potentially interfering substances found in real-world settings. Completion of the interference study is anticipated by the end of July.