Business

Intelligent Bio Solutions Initiates Additional Clinical Studies for FDA 510(k) Submission Supporting Planned Entry into Multi-Billion Dollar U.S. Market

Clinical studies designed to support FDA clearance and planned commercial launch into the world’s largest drug screening market Company anticipates full data analysis by the end of March 2026; data to be incorporated into FDA 510(k) submission package NEW YORK, Jan. 28, 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 commencement of its

articleIntelligent Bio Solutions Inc.January 28, 20264/company/intelligent-bio-solutions-inc/news/intelligent-bio-solutions-initiates-additional-133000011
Intelligent Bio Solutions Initiates Additional Clinical Studies for FDA 510(k) Submission Supporting Planned Entry into Multi-Billion Dollar U.S. Market

About this update from Intelligent Bio Solutions Inc.

[{"type":"image","alt":"Intelligent Bio Solutions, Inc.","displaySize":"","headline":null,"caption":"Intelligent Bio Solutions, Inc.","className":"","disableSlideshowImg":false,"size":{"original":{"width":300,"height":53,"url":"https://media.zenfs.com/en/globenewswire.com/9eadf03086af52dd7cf59a7dde9f27c4"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/dyf1dhe.u4apapwa.JaM4Q--/YXBwaWQ9aGlnaGxhbmRlcjt3PTQyMDtoPTc0O2NmPXdlYnA-/https://media.zenfs.com/en/globenewswire.com/9eadf03086af52dd7cf59a7dde9f27c4","width":300,"height":53}},"lazy":false},{"type":"text","content":"Clinical studies designed to support FDA clearance and planned commercial launch into the world’s largest drug screening market ","length":127,"tagName":"p"},{"type":"text","content":"Company anticipates full data analysis by the end of March 2026; data to be incorporated into FDA 510(k) submission package","length":123,"tagName":"p"},{"type":"text","content":"NEW YORK, Jan. 28, 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 commencement of its clinical study program to support its new FDA 510(k) submission for U.S. market clearance of its Intelligent Fingerprinting Drug Screening System for detection of the opiate codeine.","length":431,"tagName":"p"},{"type":"text","content":"As part of its clinical study program, the Company has again partnered with Cliantha Research, a leading clinical research organization, leveraging its extensive regulatory and clinical trial expertise.","length":202,"tagName":"p"},{"type":"text","content":"The first clinical study will assess codeine detection cut-off levels in 40 adults at a single site. The study will utilize the Intelligent Fingerprinting Drug Screening Cartridge with the DSR-Plus fluorescence reader, together forming the Company's non-invasive Intelligent Fingerprinting Drug Screening System. Participants will receive controlled doses of codeine, with sample collection and analysis conducted to establish and verify optimal detection cut-off levels. The study design includes direct comparisons with a predicate FDA-cleared device to support the 510(k) regulatory pathway. Results will be corroborated via a liquid chromatography-tandem mass spectrometry (“LC-MS/MS”) analysis. T...

More updates from Intelligent Bio Solutions Inc.

Intelligent Bio Solutions Inc.The CompanyIntelligent Bio Solutions IncIntelligent FingerprintingIntelligent BioDrug ScreeningCompanyclinical studyclinical research organizationForward-Looking Statements