regulatory
confidence high
sentiment neutral
materiality 0.65
Intelligent Bio Solutions begins interference study for FDA 510(k) clearance of fingerprint drug test for codeine
INTELLIGENT BIO SOLUTIONS INC.
- Interference Study with 75 healthy adults to validate the system's codeine specificity against everyday substances.
- Expected completion by mid-July 2026; results will be part of the FDA 510(k) submission package.
- Study runs concurrently with Method Comparison Study; follows January 2026 Cut-off Study.
- Partners again with CenExel Clinical Research to conduct the clinical trial.