Intelligent Bio Initiates Clinical Study In Fingerprint Drug Screening For Codeine
(RTTNews) - Intelligent Bio Solutions Inc. (INBS), a medical technology company, on Tuesday announced initiation of a clinical study to support a 510(k) clearance from the U.S. Food and Drug Administration (FDA) its Fingerprint Drug Screening system for the opiate codeine.
The system involves a portable mechanism to hygienically screen fingerprint sweat to determine presence of opiate drugs. The device can be utilized for quick and precise drug screening in workplaces to check for recent drug use, as results are reportedly provided within 10 minutes.
The company has partnered with CenExel Clinical Research Inc. to conduct a clinical and interference study. The study will establish the precision of the test in identifying codeine residues from samples. The results will be confirmed via liquid chromatography-tandem mass spectrometry (LC-MS/MS) analysis.
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. This reduces the number of false positives yielded by the mechanism.
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 the method comparison study.
INBS is currently trading at $2.33.
