Intelligent Bio Completes Final Clinical Study For FDA Clearance Of Codeine Screening System
(RTTNews) - Intelligent Bio Solutions Inc. (INBS), a medical technology company, on Tuesday announced the completion of its multi-site Method Comparison Study for the Intelligent Fingerprinting Drug Screening System to detect the opiate codeine.
Following the International Council for Harmonisation Good Clinical Practice (ICH GCP) guidelines, the company completed the comparison study involving 135 participants across three U.S. clinical sites.
The study was conducted in partnership with CenExel Clinical Research, with nine operators representing typical workplace drug-screening personnel. The study evaluated the system's sensitivity, specificity and accuracy for workplace and pre-employment drug screening.
This marks the completion of data collection across all FDA 510(k) clinical study program. Specimens will be independently verified using liquid chromatography-tandem mass spectrometry, or LC-MS/MS. Intelligent Bio Solutions said data analysis is underway and that it remains on track to submit its FDA 510(k) application in the second half of 2026. The submission seeks U.S. market clearance for the detection of codeine using the Intelligent Fingerprinting Drug Screening System.
Intelligent Bio Solutions believes its Intelligent Fingerprinting Drug Screening System will revolutionise portable testing through fingerprint sweat analysis, with potential applications beyond workplace safety. Current customer segments outside the U.S. include construction, manufacturing, transport, mining, drug treatment organizations, and coroners.
INBS closed Tuesday at $1.96, down 1.01%.
The shares are currently trading up 5.63% at $2.07.
