regulatory
confidence high
sentiment positive
materiality 0.65
Intelligent Bio Solutions starts clinical studies for FDA 510(k) submission to detect codeine via fingerprint
INTELLIGENT BIO SOLUTIONS INC.
- Partnered with Cliantha Research for a study in 40 adults to establish codeine detection cut-off levels.
- Study uses Intelligent Fingerprinting Drug Screening System with DSR-Plus reader; full data analysis expected by end of March 2026.
- Data will support FDA 510(k) submission and planned commercial launch into the multi-billion-dollar U.S. drug screening market.
- Company notes over 500,000 tests already sold outside the U.S.; targeting workplace, clinical, and law enforcement segments.