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 (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.
Intelligent Bio Solutions (Nasdaq: INBS) reported completion of precision testing, a key element of its planned FDA 510(k) submission seeking U.S. market clearance for its Intelligent Fingerprinting Drug Screening System to detect the opiate codeine. The study followed a clinical cut-off adjustment.
According to the company, more than 1,600 tests were conducted across three production runs and three independent testing sites, demonstrating repeatable, reproducible performance under varied manufacturing and operating conditions. These data, together with penetration testing and previously announced Cut-off, Method Comparison, and Interference studies, will support safety, accuracy, usability, specificity, security, and precision claims in the 510(k) package.
The company highlights the multi-billion-dollar annual U.S. drug screening market across workplace, criminal justice, pain management, and substance abuse treatment, and positions its non-invasive fingerprint-based system as a rapid, flexible alternative to urine, oral fluid, and blood tests, with results in under ten minutes.
Intelligent Bio Solutions (Nasdaq: INBS) has initiated an Interference Study to support FDA 510(k) clearance and planned U.S. market entry of its Intelligent Fingerprinting Drug Screening System for detecting the opiate codeine.
The study, conducted with CenExel Clinical Research, will enroll 75 healthy adults under undosed and dosed conditions. It will evaluate how handling everyday potentially interfering substances affects test specificity and accuracy, using LC-MS/MS confirmation. Completion is expected by mid-July 2026, with results included in the FDA 510(k) submission alongside a Cut-off Study and a Method Comparison Study.
Intelligent Bio Solutions (Nasdaq: INBS) announced management will participate in the Planet MicroCap Conference from June 16-18, 2026 at the Bellagio Hotel & Casino in Las Vegas.
The company will present on June 17, 2026, at 8:00–8:30 AM PDT in Track 7 – Donatello 3 and hold one-on-one investor meetings.
Intelligent Bio Solutions (Nasdaq: INBS) has started a multi-site Method Comparison Study to support an FDA 510(k) submission for U.S. clearance of its Intelligent Fingerprinting Drug Screening System for codeine detection.
The study, run with CenExel, will enroll 135 donors and assess real-world workplace accuracy, with enrollment and data collection expected to conclude by end of July 2026.
Intelligent Bio Solutions (Nasdaq: INBS) reported fiscal Q3 2026 revenue of $1.06 million, up 46% year-over-year, with cartridge sales rising 59% and contributing 66% of revenue. Gross margin reached 50.5%, nine-month revenue grew 39% to $3.07 million, and cash was $6.86 million.
The company highlighted progress toward FDA 510(k) clearance, a new manufacturing partnership, a Bouygues UK rollout, and its eighth European patent for its fingerprint drug screening technology.
Intelligent Bio Solutions (Nasdaq: INBS) launched a validation study on April 20, 2026 to accelerate its Intelligent Fingerprinting Drug Screening System from a current ~10-minute result to a target sub-3-minute (two-minute goal) analysis time.
The study is preliminary; INBS is deployed in U.S. Forensic Use Only settings and is pursuing FDA 510(k) clearance for opiate codeine. The company cites a U.S. roadside testing market of $1.17B (2023) projected to $1.62B by 2030 and a global drug screening TAM of $16.7B through 2030.