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NEW YORK, March 25, 2025 (GLOBE NEWSWIRE) -- Intelligent Bio Solutions Inc. (Nasdaq: INBS) (“INBS” or the “Company”), a medical technology company delivering intelligent, rapid, non-invasive testing solutions, today provided shareholders with a status update on the FDA clearance process for its Intelligent Fingerprint Drug Screening System, which remains on track for launch in the U.S. in 2025 targeting its opiate test system for codeine, as validated in the Company’s Pharmacokinetic (PK) study.
On December 18, 2024, the Company announced the submission of its 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for review and clearance of its Intelligent Fingerprinting Drug Screening System, which the FDA classified as a 21 CFR 862.3650, Opiate Test System, a Class II device requiring submission of a 510(k) premarket notification. This submission marked a critical milestone in the Company’s efforts to enter the U.S. market with its drug testing system in 2025.
The Company's 510(k) submission included performance data and validation studies, including a method comparison study that demonstrated the system’s 94.1% accuracy and a PK study that showed fingerprint sweat provides a reliable sample matrix for drug detection, with quantitative PK data closely aligned to blood, based on statistical comparisons made at the 95% confidence level. These findings highlight the system's accuracy, reliability, and usability, demonstrating its capacity to meet the growing demand for efficient, non-invasive testing solutions in the U.S. market.
INBS’s 510(k) submission started the 90-day period within which the FDA is required to review and respond to 510(k) submissions. As expected, the FDA has reviewed and responded with questions by issuing an Additional Information (AI) request. When the FDA issues an AI request, the 90-day review clock is paused. The Company has reviewed the AI request and is in the process of responding so that the FDA can restart the review clock. As a result of this process, although the FDA is required to review and respond in 90 days, it is not uncommon for the FDA clearance process to take three to six months or longer if additional data is required. As INBS awaits FDA clearance, it continues to develop its plans to enter the multi-billion-dollar U.S. market in 2025 and pursue FDA clearance for additional drug classes on its panel. The Company’s full panel test is already widely adopted, with a presence in 19 countries and over 400 accounts globally.
"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. As we await FDA clearance, we remain confident in the strength of our data, which demonstrates the accuracy, reliability, and usability of our technology. 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."