INTELLIGENT BIO SOLUTIONS INC. 8K

Intelligent Bio Solutions reported improved clinical performance of its drug screening system and confirmed plans to submit an FDA 510(k) application in September 2026 to support U.S. market entry.

On September 1, 2026, Intelligent Bio Solutions Inc. announced results from a multi-site U.S. Method Comparison Study of its Intelligent Fingerprinting Drug Screening System for detecting the opiate codeine, showing improved performance with accuracy above 98%, sensitivity above 94%, and maintained specificity of 100% versus a validated LC-MS/MS reference method, representing a substantial improvement over prior 2024 study results and providing the final clinical data needed to support the company’s planned FDA 510(k) submission, now expected to be filed in September 2026 as a key step toward entering the U.S. market following regulatory clearance.

Filing Facts

CIK

1725430

Ticker

-

Form

8K

Source Type

sec

Accession

0001493152-26-041055

Alert Tier

6