Intelligent Bio Solutions (INBS),Tuesday announced that its FDA clearance process for the Intelligent Fingerprint Drug Screening System is progressing as planned, with the company on track for a U.S. launch in 2025, targeting its opiate test system for codeine.
The company submitted its 510(k) premarket notification to the U.S. FDA in December 2024, and the system has been classified as a Class II Opiate Test System.
This submission marks a critical step in bringing the drug screening system to the U.S. market.
The submission included performance data, including a method comparison study that demonstrated a 94.1 percent accuracy rate and a pharmacokinetic or PK study showing that fingerprint sweat is a reliable sample for drug detection.
These findings reinforce the system's accuracy, reliability, and ability to meet the growing demand for non-invasive testing solutions.
The FDA has issued an Additional Information (AI) request, pausing the 90-day review period as expected.
INBS is currently responding to the request and is confident in the strength of its data.
The company continues to prepare for its 2025 U.S. launch and is working toward FDA clearance for additional drug classes in the future.
If successful, INBS aims to revolutionize drug screening with its non-invasive, rapid testing solution, which has already been adopted in 19 countries and is used by over 400 accounts globally.
Currently, INBS is trading at $1.76 down by 16.58 percent on the Nasdaq.
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