Study results finalized on schedule support FDA clearance and planned U.S. commercial launch
Company advances second phase of clinical program for 510(k) submission with method comparison, usability, and interference testing
NEW YORK, April 02, 2026 (GLOBE NEWSWIRE) -- Intelligent Bio Solutions Inc. (Nasdaq: INBS) ("INBS" or the "Company"), a medical technology company delivering intelligent, rapid, non-invasive testing solutions, today announced the successful completion of its initial clinical Cut-off Study supporting the Company's FDA 510(k) submission for U.S. market clearance of its Intelligent Fingerprinting Drug Screening System for detection of the opiate codeine.
The clinical Cut-off Study evaluated codeine detection cut-off levels in 40 adults, with full data analysis completed as planned by the end of March 2026. The study used the Intelligent Fingerprinting Drug Screening Cartridge with the DSR-Plus fluorescence reader, compared results with an FDA-cleared predicate device, and confirmed findings through liquid chromatography-tandem mass spectrometry (“LC-MS/MS”) analysis.
INBS has now initiated the second phase of its clinical study program. This includes a multi-site Method Comparison and Usability Study. This study is designed to validate the system’s accuracy, usability, and workplace performance when operated by intended end users at several clinical sites. The Company expects to complete the Method Comparison and Usability Study by the end of June 2026. In parallel with the Method Comparison and Usability Study, the Company will be commencing an Interference Study, which will test the device in the presence of potentially interfering substances found in real-world settings. Completion of the Interference Study is anticipated by the end of July 2026.
"The U.S. drug screening market is a significant commercial opportunity for Intelligent Bio Solutions," said Harry Simeonidis, President and CEO at INBS, "The on-schedule completion of our Cut-off Study validates our clinical approach and keeps us firmly on track toward our FDA 510(k) submission and planned commercial launch."
The U.S. drug screening market represents a multi-billion-dollar annual opportunity. Major segments include workplace testing, criminal justice, pain management, and substance abuse treatment. The Company’s non-invasive fingerprint technology offers several advantages over traditional urine, oral fluid, and blood testing methods. Benefits include a detection window designed to identify current impairment rather than past use, rapid results, and the ability to conduct screening at any time and location.
About Intelligent Bio Solutions Inc.
Intelligent Bio Solutions Inc. (Nasdaq: INBS) is a medical technology company delivering intelligent, rapid, non-invasive testing solutions. The Company believes that its Intelligent Fingerprinting Drug Screening System will revolutionize portable testing through fingerprint sweat analysis, which has the potential for broader applications in additional fields. Designed as a hygienic and cost-effective system, the test screens for the recent use of drugs commonly found in the workplace, including opiates, cocaine, methamphetamine, and cannabis. With sample collection in seconds and results in under ten minutes, this technology would be a valuable tool for employers in safety-critical industries. The Company’s current customer segments outside the U.S. include construction, manufacturing and engineering, transport and logistics firms, mining, drug treatment organizations, and coroners.
For more information, visit: https://ibs.inc/
Forward-Looking Statements
Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934, and the Private Securities Litigation Reform Act of 1995, and involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, statements regarding Intelligent Bio Solutions Inc.’s ability to successfully develop and commercialize its drug and diagnostic tests, realize commercial benefits from its partnerships and collaborations, and secure regulatory clearance or approvals, among others. Although Intelligent Bio Solutions Inc. believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, actual results may differ materially from those expressed or implied by such statements. Intelligent Bio Solutions Inc. has attempted to identify forward-looking statements by terminology, including “believes,” “estimates,” “anticipates,” “expects,” “plans,” “projects,” “intends,” “potential,” “may,” “could,” “might,” “will,” “should,” and “approximately,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those described in Intelligent Bio Solutions’ public filings with the U.S. Securities and Exchange Commission. Any forward-looking statements contained in this release speak only as of the date of this release. Intelligent Bio Solutions undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.
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