INBS News & Events

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 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 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."

Intelligent Bio Solutions 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.