Welcome to our dedicated page for Intelligent Bio Solutions news (Ticker: INBS), a resource for investors and traders seeking the latest updates and insights on Intelligent Bio Solutions stock.
Intelligent Bio Solutions Inc. develops medical technology for rapid, non-invasive testing, centered on fingerprint sweat drug screening. Its updates commonly cover the Intelligent Fingerprinting Drug Screening System, Drug Screening Cartridges, DSR-Plus reader, lateral-flow test strip manufacturing, and the reader-and-consumable sales model used in workplace testing markets outside the United States.
Company news also focuses on clinical and regulatory work supporting an FDA 510(k) pathway for codeine detection, cybersecurity and validation testing tied to the system, European patent protection for fingerprint chemical analysis, manufacturing scale-up for readers and cartridges, customer deployments in the United Kingdom, and periodic revenue reports by product category.
Intelligent Bio Solutions (INBS) will host a virtual fireside chat on Thursday, September 24, 2026, at 4:30 p.m. ET.
The moderated discussion will feature President and CEO Harry Simeonidis and Vice President of Product Development Peter Passaris. Topics include the company’s FDA 510(k) submission for its Intelligent Fingerprinting Drug Screening System, supporting clinical data, the FDA review process, and commercial progress outside the United States. The event will be accessible via live webcast through an online registration link, with a replay available on the company’s investor relations website after the session.
Intelligent Bio Solutions (INBS) has submitted an FDA 510(k) application for its Intelligent Fingerprinting Drug Screening System to detect codeine.
The package is based on a multi-study 2026 clinical program run with Cliantha Research and CenExel Clinical Research, generating over 18,000 hours of data, 18 test reports, more than 170 attachments, and over 15,000 data lines. A Method Comparison Study showed accuracy above 98%, sensitivity above 94%, and 100% specificity, with all samples verified by LC‑MS/MS. Additional studies confirmed usability by non-specialist operators, robustness against common workplace substances, and repeatable performance across more than 1,600 tests at three sites and production runs.
Cybersecurity documentation remediated 100% of medium-risk items and all 19 SBOM vulnerabilities, with third-party verification. FDA clearance, if obtained, is expected to support broader U.S. commercialization beyond Forensic Use Only settings in the multi‑billion‑dollar drug screening market.
Intelligent Bio Solutions (Nasdaq: INBS) reported results from a multi-site U.S. Method Comparison Study of its Intelligent Fingerprinting Drug Screening System for detecting the opiate codeine. Conducted at three independent clinical sites in pre-employment and workplace settings, the study assessed sensitivity, specificity and accuracy against an LC-MS/MS reference method.
The System achieved total accuracy of 98.2%, sensitivity of 94.6%, and specificity of 100% across 214 samples (144 true negatives, 70 true positives, 4 false negatives, 0 false positives). Accuracy and sensitivity improved versus a prior 2024 study, which showed approximately 94% accuracy and 82% sensitivity, while specificity remained at 100%. The data complete the company’s FDA 510(k) clinical package, and Intelligent Bio Solutions now expects to submit its 510(k) application for the System in September 2026, supporting a planned U.S. market entry following potential FDA clearance.
Intelligent Bio Solutions (Nasdaq: INBS) entered a securities purchase agreement with a single existing institutional investor for a private placement priced at-the-market under Nasdaq rules. The company will issue 2,036,659 shares of common stock (or Series M pre-funded warrants), plus Series N-1 and Series N-2 warrants to purchase up to 2,036,659 shares each, at a combined purchase price of $2.455 per share unit, for expected gross proceeds of about $5.0 million before fees.
The Series N-1 and N-2 warrants have an exercise price of $2.33 per share. N-1 warrants are exercisable immediately; N-2 warrants become exercisable upon stockholder approval. Both series have five-year terms starting when related resale registration statements are declared effective by the SEC. Subject to certain conditions, the N-1 warrants are callable at the company’s option after it publicly announces FDA 510(k) clearance of its Intelligent Fingerprinting Drug Screening System. Closing is expected on or about September 2, 2026, with net proceeds intended for working capital and general corporate purposes.
Intelligent Bio Solutions (Nasdaq: INBS) reported fiscal 2026 revenue of $4.2 million, up 38% year-over-year, driven by a 22% increase in reader installed base to 1,886 units and a 35% rise in consumable cartridges to 106,500. Gross profit grew 64% to $2.05 million, with gross margin expanding 778 basis points to 48.63%, supported by a manufacturing shift to Syrma Johari and a higher mix of cartridge consumables.
INBS ended June 30, 2026 with 502 active customers and cash of $3.99 million. Net loss attributable to the company widened to $12.43 million from $10.57 million as operating expenses rose to $15.34 million. According to the company, all clinical data collection for its FDA 510(k) program is complete, multiple supporting studies have been finalized, and an FDA submission is targeted for the second half of calendar 2026 to support planned U.S. market entry.
Intelligent Bio Solutions (Nasdaq: INBS) announced recertification of its Intelligent Fingerprinting Drug Screening business to the ISO 13485:2016 medical device quality management standard. The new certificate, issued by the British Standards Institution, becomes effective October 14, 2026 and is valid for three years.
According to the company, this aligns its UK FDA-registered facility with the ISO 13485:2016 standard incorporated into the FDA’s amended Quality Management System Regulation, supporting its ongoing FDA clearance application for codeine detection. INBS also completed ISO 9001:2015 recertification, supporting operations across regulated markets in the US, Canada, Europe, and Asia Pacific.
Intelligent Bio Solutions (Nasdaq: INBS) has completed its multi-site Method Comparison Study for the Intelligent Fingerprinting Drug Screening System, a key component of its FDA 510(k) submission for U.S. market clearance to detect the opiate codeine. All clinical data collection across the company’s 510(k) clinical program is now finished.
The ICH GCP-compliant study ran over three weeks at three independent U.S. sites with 135 participants and nine operator users, reflecting typical workplace screening staff. Specimens will be verified via LC-MS/MS, and data analysis is underway as INBS targets submission in the second half of 2026.
Intelligent Bio Solutions (Nasdaq: INBS) announced completion of a Usability Study for its Intelligent Fingerprinting Drug Screening System, supporting an FDA 510(k) submission for U.S. market clearance to detect the opiate codeine. The study, run with CenExel Clinical Research, followed FDA guidance and ICH GCP standards and assessed how effectively non-specialist operators could be trained and could then use the system in a workplace environment.
Fifteen operators without specialist laboratory knowledge or prior system experience participated, and according to Intelligent Bio Solutions, results confirm the system can be administered accurately by users with no specialist background. The Usability Study is part of a broader 510(k) program that also includes Cut-off, Method Comparison, Interference, precision, and penetration studies. The company states it remains on track to submit its 510(k) package in calendar H2 2026 as it targets entry into the U.S. drug screening market.
Intelligent Bio Solutions (Nasdaq: INBS) announced completion of its Interference Study for the Intelligent Fingerprinting Drug Screening System, a key component of its planned FDA 510(k) submission for U.S. market clearance for detection of the opiate codeine.
The study, conducted with CenExel Clinical Research under FDA guidance and ICH GCP standards, evaluated whether everyday substances such as hand creams, alcohol-based products, oils, dirt, and water impact test accuracy. Data analysis, including independent LC-MS/MS verification, is underway. The Interference Study forms part of a broader program including a clinical Cut-off Study, Method Comparison Study, precision testing, and penetration testing, aimed at addressing safety, accuracy, usability, specificity, and precision requirements. INBS expects to submit its 510(k) package in H2 2026, supporting its planned entry into the multi-billion-dollar U.S. drug screening market.
Intelligent Bio Solutions (Nasdaq: INBS) reported completing remediation of all cybersecurity and software-related review items ahead of its planned FDA 510(k) submission in calendar H2 2026 for its Intelligent Fingerprinting Drug Screening System.
After independent third-party penetration testing identified no major vulnerabilities in April 2026, INBS has now achieved 100% remediation of medium-risk vulnerabilities and reduced low-risk items from 11 to 2, with the remainder supported by risk-based justifications indicating no impact on device safety, effectiveness, or performance. All 19 software bill of materials vulnerabilities have also been resolved, and independent verification confirmed no remaining issues. The 510(k) package targets codeine detection as the initial indication, aiming to expand opportunities beyond Forensic Use Only settings in the multi-billion-dollar U.S. drug screening market. According to INBS, its manufacturing partnership with Syrma Johari MedTech is expected to deliver more than 40% annual production cost savings and approximately 20 percentage points of annual gross margin improvement, supporting a scalable U.S. launch following any future FDA clearance.