Intelligent Bio Solutions Inc. (NASDAQ: INBS) shares cleared breakeven Wednesday. The medical technology company delivering intelligent, rapid, non-invasive testing solutions announced the submission of its 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for clearance following FDA review of its Intelligent Fingerprinting Drug Screening System, an innovative, rapid and pain-free method for drug screening. The submission represents a critical milestone on the Company’s path to realizing its goal of entering the US market with its drug testing solution 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 Pharmacokinetic (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 US market.
With existing adoption in international markets, the System has already demonstrated its value in delivering substantial cost savings, operational efficiencies, and rapid results with minimal disruption. Entry into the U,S,, one of the largest drug screening markets globally, will support INBS' ongoing global expansion, presenting opportunities for revenue growth, market share acquisition, and strategic partnerships.
INBS shares took on four cents, or 2.5%, to $1.40.
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