other material
confidence high
sentiment positive
materiality 0.55
INBS completes interference study; on track for 510(k) submission in H2 2026
INTELLIGENT BIO SOLUTIONS INC.
- Completed Interference Study for fingerprint drug screening system, testing common substances (hand creams, alcohol, oils, dirt, water) for impact on codeine detection.
- Study conducted with CenExel Clinical Research, following FDA guidance and ICH GCP guidelines; data analysis underway with LC-MS/MS verification.
- Company remains on track to submit FDA 510(k) package in calendar H2 2026 for U.S. market clearance for opiate codeine detection.
- Part of comprehensive program including Cut-off Study, Method Comparison Study, precision and penetration testing.