The Company has again partnered with CenExel Clinical Research, Inc. to complete the clinical study. The Interference Study will assess how potentially interfering substances may impact the Intelligent Fingerprinting Drug Screening System's accuracy and reliability. The study will enroll 75 healthy adult participants who will be evaluated under both undosed and dosed conditions while handling substances that could potentially interfere with test results. This rigorous protocol aims to show the system maintains codeine specificity, even when subjects have handled everyday substances before testing.
Interference testing is a critical FDA requirement that validates whether a diagnostic system can distinguish the target analyte from other substances encountered in daily life or workplace environments. The study evaluates whether handling common interferents affects the system's ability to accurately detect codeine, preventing false-positive or false-negative results that could have serious consequences for workplace drug screening programs.
The study's protocol includes multiple collection time points, with results confirmed via liquid chromatography-tandem mass spectrometry ("LC-MS/MS") analysis. This comprehensive approach ensures accurate system performance in varied real-world scenarios.
"Interference testing is critical to delivering a specific, reliable drug screening solution," said Harry Simeonidis, President and CEO at Intelligent Bio Solutions. "By rigorously testing how everyday substances might affect our system, we address a fundamental workplace drug screening concern by delivering results employers and employees can trust. This study is an important step toward FDA clearance and reinforces the robustness of our drug testing technology."
The Interference Study will run concurrently with the Company's Method Comparison Study and follows the clinical Cut-off Study that commenced in January 2026. Together, these three complementary studies form a comprehensive clinical package designed to meet FDA 510(k) requirements and demonstrate the safety, accuracy, usability, and specificity of the Intelligent Fingerprinting Drug Screening System.
The study will follow FDA guidance and ICH GCP (International Council for Harmonisation Good Clinical Practice) Guidelines. The Company expects to finish the study by mid-July 2026. Results will be included in its FDA 510(k) submission package, along with data from the Cut-off Study and Method Comparison Study.
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