Intelligent Bio Solutions Inc. (Nasdaq: INBS) announced that the FDA clearance process for its Intelligent Fingerprint Drug Screening System remains on track for a U.S. market launch in 2025. The company's innovative technology, which uses fingerprint sweat analysis to detect recent drug use, is initially targeting approval for its opiate test system for codeine.
The company submitted its 510(k) premarket notification to the U.S. Food and Drug Administration on December 18, 2024. The FDA has classified the system as a 21 CFR 862.3650 Opiate Test System, a Class II device requiring 510(k) clearance.
Strong Clinical Validation Data
INBS's submission included comprehensive performance data and validation studies that demonstrated the system's effectiveness. A method comparison study showed 94.1% accuracy in drug detection. Additionally, a pharmacokinetic (PK) study confirmed that fingerprint sweat provides a reliable sample matrix for drug detection, with quantitative PK data closely aligned to blood-based testing at the 95% confidence level.
"The submission of our 510(k) premarket notification to the FDA marked a pivotal step in the journey to bring our Intelligent Fingerprint Drug Screening System to the U.S. market," said Harry Simeonidis, President and CEO at INBS. "We appreciate the thoroughness of the FDA's process, which aligns with our expectations."
Current Status of FDA Review
As part of the standard review process, the FDA has issued an Additional Information (AI) request after the initial 90-day review period. This has temporarily paused the review clock while INBS prepares its response. While the FDA is required to review and respond to 510(k) submissions within 90 days, the complete clearance process typically takes three to six months or longer when additional data requests occur.
The company reports that it has reviewed the AI request and is currently preparing its response to restart the FDA review clock.
Market Potential and Global Presence
The Intelligent Fingerprint Drug Screening System offers significant advantages over traditional drug testing methods. The technology provides results in under ten minutes with sample collection taking only seconds. It screens for commonly misused substances including opiates, cocaine, methamphetamine, and cannabis.
The system is designed as a hygienic and cost-effective solution, particularly valuable for employers in safety-critical industries. Its non-invasive nature represents a major advancement over conventional testing methods that require blood, urine, or saliva samples.
INBS's technology has already gained significant traction internationally, with a presence in 19 countries and over 400 accounts globally. Current customers outside the U.S. include organizations in construction, manufacturing, engineering, transport and logistics, drug treatment, and coroner services.
Future Expansion Plans
While awaiting FDA clearance for its opiate test, INBS is developing plans to pursue approval for additional drug classes on its panel. The company views the U.S. as a multi-billion-dollar market opportunity where its non-invasive, rapid testing solution could revolutionize drug screening practices.
"As we await FDA clearance, we remain confident in the strength of our data, which demonstrates the accuracy, reliability, and usability of our technology," Simeonidis added. "We are actively preparing for our planned U.S. launch in 2025, where we see significant opportunities to revolutionize drug screening with our non-invasive, rapid testing solution."
The company believes its fingerprint sweat analysis technology has potential for broader applications beyond its current focus, positioning INBS for continued growth in the medical diagnostics sector.
