INBS news

Intelligent Bio Solutions Inc. submitted a 510(k) package to the FDA for its Intelligent Fingerprinting Drug Screening System, targeting U.S. market clearance for codeine detection.

Intelligent Bio Solutions Inc. reported fiscal 2026 revenue of $4.2 million, up 38% year-over-year, driven by a growing reader installed base and high-margin cartridge sales. Gross profit margin expanded 778 basis points to 48.63%.

Intelligent Bio Solutions completed a usability study for its Intelligent Fingerprinting Drug Screening System confirming effective use by non-specialist operators. This milestone aligns with the company's plan to submit a 510(k) in Q3 2026 to enter the U.S. market.

Intelligent Bio Solutions has completed an interference study to validate the accuracy of its drug screening system under real-world conditions, solidifying plans to submit the FDA 510(k) package in the second half of 2026 to enter the U.S. market.

The company resolved all cybersecurity and software review items, de-risking the regulatory path for its fingerprint drug test. The move positions INBS for U.S. market entry into a multi-billion-dollar industry.

Intelligent Bio Solutions completed precision testing of its fingerprint drug screen across three sites to support its FDA 510(k) submission for the U.S. opiate detection market, valued at over $1 billion.

Intelligent Bio Solutions initiated a clinical study with CenExel to validate its Intelligent Fingerprinting Drug Screening System for FDA clearance, with enrollment completion expected by July 2026. The study demonstrates real-world usability by non-specialized personnel, a key competitive advantag…