Intelligent Bio Solutions Aktie

Intelligent Bio Solutions has completed the multicenter method comparison study as the final component of its clinical FDA program, thereby collecting all clinical data required for 510(k) clearance. The three-week study was conducted at three independent U.S. sites with 135 subjects and nine typical users. Analysis is ongoing; all samples are being independently tested by liquid chromatography–tandem mass spectrometry. The company plans to submit the 510(k) application in the second half of 2026. » More on de.investing.com

Intelligent Bio Solutions has completed a usability study for its Intelligent Fingerprinting Drug Screening System as part of the FDA 510(k) submission to demonstrate detection of the opiate codeine. The study with 15 users showed the system can be operated accurately by personnel without specialized laboratory experience. The usability study complements other regulatory studies; the company plans to file the 510(k) package in the second half of 2026. The system provides samples in seconds and results in under ten minutes for multiple drug classes. » More on de.investing.com

Intelligent Bio Solutions has launched a multicenter method-comparison study to support its FDA 510(k) submission for the "Intelligent Fingerprinting Drug Screening System" to detect opiates (codeine). The study, with 135 randomly assigned donor participants and nine typical users, is being conducted in partnership with CenExel; results will be confirmed by LC-MS/MS and are expected by the end of July 2026. The goal is to demonstrate that the system can be operated accurately by personnel without specialized laboratory training; the data will be included in the 510(k) package together with a cut-off study started in January. The company already sells the technology outside the U.S., has a market capitalization of USD 5.93 million, and recently experienced a sharp share-price decline alongside rising revenue and rapid cash burn. » More on de.investing.com