Intelligent Bio Solutions Seeks FDA Clearance For Fingerprint-Based Drug Screening System
(RTTNews) - Intelligent Bio Solutions, Inc. (INBS) announced that it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) seeking clearance for its Intelligent Fingerprinting Drug Screening System to detect the opiate codeine.
The submission includes clinical data generated through a multi-study program conducted with Cliantha Research and CenExel Clinical Research in accordance with FDA guidance and International Council for Harmonisation Good Clinical Practice standards.
The clinical program included more than 18,000 hours of data collection, 18 detailed test reports, more than 170 supporting attachments and over 15,000 lines of data.
A Method Comparison Study demonstrated accuracy above 98%, sensitivity above 94% and 100% specificity across three independent U.S. clinical sites.
All specimens in the Method Comparison Study were independently verified using liquid chromatography-tandem mass spectrometry (LC-MS/MS).
A Usability Study showed that the System could be administered effectively by operators without specialist laboratory knowledge or prior experience, supporting its potential use in workplace settings.
An Interference Study found that common workplace substances, including hand creams, alcohol-based products, oils, dirt and water, did not affect the System's accuracy or specificity for codeine.
Precision testing demonstrated repeatable and reproducible performance across more than 1,600 tests conducted over three production runs and three independent sites.
A Cut-off Study evaluated codeine detection thresholds in 40 adult participants, with results compared against an FDA-cleared predicate device and confirmed through LC-MS/MS analysis.
The 510(k) package also includes cybersecurity and software documentation addressing FDA review requirements.
The company said 100% of medium-risk cybersecurity vulnerabilities were remediated, while all 19 software bill of materials (SBOM) vulnerabilities were resolved and independently verified as having no remaining issues.
Intelligent Bio Solutions said the combined clinical and technical findings support the accuracy, reliability, specificity and usability of its drug screening technology and its ability to meet requirements under the FDA 510(k) pathway.
The Intelligent Fingerprinting Drug Screening System uses fingerprint sweat analysis to provide rapid, non-invasive drug screening.
The system is designed to detect recent use of drugs commonly found in workplace testing, including opiates, cocaine, methamphetamine and cannabis, with sample collection completed in seconds and results available in less than 10 minutes.
The technology is already commercially deployed outside the U.S. across workplace, law enforcement and government settings.
INBS said FDA clearance would expand the potential U.S. applications of its technology beyond Forensic Use Only settings and support its broader commercialization strategy.
The company is targeting the multi-billion-dollar U.S. drug screening market, including workplace testing, criminal justice, pain management, law enforcement and substance abuse treatment.
Intelligent Bio Solutions said its current customer base outside the U.S. includes construction, manufacturing and engineering, transportation and logistics, mining, drug treatment organizations and coroners.
INBS has traded between $1.52 and $24.90 over the past year. The stock closed Tuesday's trading at $2.15, down 4.02%. In pre-market trading the stock is at $2.23, up 4.02%.
