regulatory
confidence high
sentiment positive
materiality 0.65
INBS reports 98.2% accuracy in codeine drug screen study; 510(k) submission on track for Sept 2026
INTELLIGENT BIO SOLUTIONS INC.
- Multi-site study across 3 U.S. clinical sites: 98.2% accuracy, 94.6% sensitivity, 100% specificity for opiate codeine.
- Improvement from prior Nov 2024 study: ~94% accuracy and 82% sensitivity; specificity unchanged at 100%.
- Results measured against validated LC-MS/MS reference method; 70 true positives, 144 true negatives, 0 false positives.
- Company accelerated filing timeline; expects to submit 510(k) application in September 2026 for U.S. market entry.
- CEO Harry Simeonidis: 'we now have everything we need for our 510(k) submission.'