regulatory
confidence high
sentiment positive
materiality 0.60
Intelligent Bio Solutions completes precision testing for FDA 510(k) submission for codeine detection
INTELLIGENT BIO SOLUTIONS INC.
- Precision testing included over 1,600 tests across three production runs and three independent sites.
- Results confirmed repeatable, reproducible performance, strengthening the FDA 510(k) submission package.
- Submission targets U.S. market clearance for the Intelligent Fingerprinting Drug Screening System for opiate codeine.
- Company plans U.S. launch after FDA 510(k) clearance, citing a multi-billion-dollar annual drug screening market.
- CEO Harry Simeonidis stated the testing puts the company firmly on track for submission and launch.