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Intelligent Bio Solutions starts interference study for FDA drug screening submission

June 16, 2026 8:30 AM

Intelligent Bio Solutions Inc. (NASDAQ: INBS) has initiated an Interference Study to support its FDA 510(k) submission for U.S. market clearance of its Intelligent Fingerprinting Drug Screening System for codeine detection, according to a press release from the company.

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. The protocol includes multiple collection time points, with results confirmed via liquid chromatography-tandem mass spectrometry (LC-MS/MS) analysis.

The company has partnered again with CenExel Clinical Research, Inc. to conduct the study, which will follow FDA guidance and ICH GCP Guidelines. INBS expects to complete the study by mid-July 2026.

The Interference Study runs concurrently with the company's Method Comparison Study and follows a Cut-off Study that commenced in January 2026. Results from all three studies are planned for inclusion in the FDA 510(k) submission package.

"Interference testing is critical to delivering a specific, reliable drug screening solution," said Harry Simeonidis, President and CEO of Intelligent Bio Solutions. "This study is an important step toward FDA clearance and reinforces the robustness of our drug testing technology."

The Intelligent Fingerprinting Drug Screening System uses fingerprint sweat analysis to screen for drugs including opiates, cocaine, methamphetamine, and cannabis. The company currently serves customers outside the U.S. in sectors including construction, transport, mining, and drug treatment organizations.

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