Intelligent Bio Solutions Inc. (NASDAQ:INBS) ("INBS" or the "Company"), a medical technology company delivering intelligent, rapid, non-invasive testing solutions, today announced the results of its latest Method Comparison Study for its Intelligent Fingerprinting Drug Screening System (the "System") to detect the opiate codeine. Conducted across three independent U.S. clinical sites, the study represents the most comprehensive evaluation of the System in the Company's FDA 510(k) clinical study program. The study results show substantially improved performance compared to the Company's prior Method Comparison Study, announced in November of 2024.
The purpose of the study was to evaluate the System's consistency and reliability across diverse clinical environments. The study followed established clinical research guidelines and evaluated the sensitivity, specificity, and accuracy of the Intelligent Fingerprinting Drug Screening System in pre-employment and workplace screening environments.
Method Comparison Study Results
| Parameter | Site 1 | Site 2 | Site 3 | Total |
| True Negative | 48 | 45 | 51 | 144 |
| False Negative | 1 | 2 | 1 | 4 |
| True Positive | 27 | 27 | 16 | 70 |
| False Positive | 0 | 0 | 0 | 0 |
| Sensitivity | 96.4% | 93.1% | 94.1% | 94.6% |
| Specificity | 100% | 100% | 100% | 100% |
| Accuracy | 98.7% | 97.3% | 98.5% | 98.2% |
The System demonstrated accuracy above 98%, sensitivity above 94%, and specificity of 100% for the opiate codeine. These figures represent a notable increase from the Company's previous study, which reported approximately 94% accuracy and 82% sensitivity. The System's 100% specificity, unchanged from the prior study, continues to confirm its ability to correctly identify samples that do not contain the target drug, a critical requirement for workplace drug testing applications where false positives can carry significant consequences. Results were measured against a validated liquid chromatography-tandem mass spectrometry ("LC-MS/MS") reference method.
"These results have been a long time in the making," said Harry Simeonidis, President and CEO of Intelligent Bio Solutions. "Our System was already delivering 100% specificity, but we knew we needed to close the gap on sensitivity. Moving from approximately 82% sensitivity to above 94%, and in doing so lifting our overall accuracy to above 98%, is the outcome we were working toward. With this study complete, we now have everything we need for our 510(k) submission, which remains on track for submittal in calendar 2026."
The results form a critical component of the Company's 510(k) submission package. With all data collection now complete, the Company has accelerated its filing timeline and expects to submit its 510(k) application in September 2026, supporting its planned entry into the U.S. market following FDA clearance.