Intelligent Bio Solutions Completes Precision Testing For FDA Submission
(RTTNews) - Intelligent Bio Solutions Inc. (INBS), a medical technology company delivering rapid, non-invasive testing solutions, announced the successful completion of precision testing for its Intelligent Fingerprinting Drug Screening System, a key component of its FDA 510(k) submission for U.S. market clearance.
Precision Testing Results
The testing confirmed reproducibility across more than 1,600 tests, three production runs, and three independent sites, demonstrating consistent performance under varied manufacturing conditions and operating environments. Results showed reliable, repeatable outcomes, supporting the system's suitability for workplace and other drug screening settings.
Harry Simeonidis, President and CEO of Intelligent Bio Solutions, stated: "Completing over 1,600 tests across multiple independent sites and production runs puts us firmly on track for our FDA 510(k) submission, and, once FDA 510(k) clearance is obtained, a planned U.S. launch." He added that the depth of the dataset reflects the rigor applied to the submission process.
Submission Package
The precision testing results will be included in the FDA 510(k) application alongside data from penetration testing, the Cut-off Study, Method Comparison Study, and Interference Study. Together, these datasets address safety, accuracy, usability, specificity, security, and precision.
Market Opportunity
The U.S. drug screening market represents a multi-billion-dollar annual opportunity across workplace testing, criminal justice, pain management, and substance abuse treatment. The company's non-invasive fingerprint technology offers advantages over traditional urine, oral fluid, and blood testing, including rapid results in under ten minutes, hygienic sample collection, and a detection window designed to identify recent drug use.
About the Company
Intelligent Bio Solutions believes its Intelligent Fingerprinting Drug Screening System will revolutionize portable testing through fingerprint sweat analysis, with potential applications beyond workplace safety. Current customer segments outside the U.S. include construction, manufacturing, transport, mining, drug treatment organizations, and coroners.
The company implemented 1-for-10 reverse stock split on December 15, 2025.
INBS closed Tuesday's trading at $1.81, down 8.12%.
