Clinical Trials
6
2 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
N/A
Active, not recruiting
1
16.7%
Completed
2
33.3%
Enrolling By Invitation
1
16.7%
Recruiting
2
33.3%
No approval data available
- Intelligent Bio Solutions completed precision testing involving over 1,600 tests across three production runs and three independent sites for its fingerprint-based drug screening system. - The precision testing confirmed consistent, repeatable, and reproducible performance for codeine detection, supporting the company's upcoming FDA 510(k) submission. - Results will be combined with data from the Cut-off Study, Method Comparison Study, and Interference Study to address safety, accuracy, usability, specificity, security, and precision. - The company targets the multi-billion-dollar U.S. drug screening market spanning workplace testing, criminal justice, pain management, and substance abuse treatment.
- Intelligent Bio Solutions received European Patent EP3752831 for contextualizing fingerprint chemical analysis with fingerprint deposition volume, marking the company's eighth European patent. - The patented technology improves substance interpretation by correlating chemical findings with fingerprint residue volume, strengthening the robustness of the testing process. - The company's fingerprint sweat drug testing system screens for opiates, cocaine, methamphetamine, and cannabis with sample collection in seconds and results in under ten minutes. - The growing European IP portfolio encompasses multiple aspects of the screening system, including lateral flow fingerprint analysis, sample collection cartridges, and test strip readers.
- Intelligent Bio Solutions announced a strategic manufacturing partnership with Syrma Johari MedTech Ltd. to scale production of its Intelligent Fingerprinting Drug Screening Reader. - The collaboration is expected to deliver annual production cost savings of more than 40%, translating to an expected improvement of approximately 20 percentage points in gross margin. - Syrma Johari's manufacturing capacity is approximately four times INBS' current capacity, positioning the company to efficiently support anticipated demand as it scales commercial operations. - The partnership strengthens INBS' global manufacturing strategy while reducing reliance on a single supplier and building greater supply chain resilience ahead of planned U.S. market entry in 2026.
- Intelligent Bio Solutions' pharmacokinetic study demonstrates that fingerprint sweat mirrors the rate and extent of codeine found in blood and saliva, establishing it as a strong indicator of drug ingestion. - Statistical comparisons at the 95% confidence level showed that fingerprint sweat provides a reliable sample matrix for drug detection, with quantitative pharmacokinetic data closely aligning with blood-based results. - The company will present these findings at the ADLM 2025 Clinical Lab Expo, reinforcing the viability of their non-invasive Intelligent Fingerprinting Drug Screening System for diagnostic testing. - With over 450 accounts across 24 countries, the technology offers rapid results in under ten minutes and addresses growing demand for innovative drug screening approaches that minimize biohazard risks.
- Intelligent Bio Solutions Inc. (INBS) has formed a strategic partnership with Detecto in Spain and Andorra, targeting a drug testing market expected to reach $448 million by 2030. - The company's non-invasive fingerprint drug testing technology is already being utilized by major Spanish clients including Metro Barcelona and a large Rio Tinto mine, requiring 1,000 testing cartridges monthly. - INBS has surpassed 450 active accounts globally across 24 countries, with recent expansion into luxury marine, retail, and waste management sectors, positioning the company for entry into the U.S. testing market.
- Intelligent Bio Solutions Inc. has submitted its 510(k) premarket notification to the FDA for its Intelligent Fingerprint Drug Screening System, with clearance expected in 2025 for its opiate test system for codeine. - The system demonstrated 94.1% accuracy in method comparison studies and showed fingerprint sweat provides a reliable sample matrix for drug detection, with PK data closely aligned to blood at 95% confidence level. - Already established in 19 countries with over 400 accounts globally, the non-invasive technology delivers drug screening results in under ten minutes and targets the multi-billion-dollar U.S. market.
- Intelligent Bio Solutions Inc. (INBS) has been granted its sixth U.S. patent, strengthening intellectual property protection for its fingerprint sweat-based drug screening technology ahead of planned 2025 U.S. market entry. - The new patent (No. 12259385) specifically protects the proprietary lateral flow test strip inside the company's Drug Screening Cartridge, a core component that enables detection of common drugs of abuse through fingerprint sweat analysis. - INBS's non-invasive drug testing solution provides results in under ten minutes and targets safety-sensitive industries, positioning the company to compete in the multi-billion dollar U.S. drug screening market following its FDA 510(k) submission in December 2024.
- Intelligent Bio Solutions reports positive pharmacokinetic study results, indicating fingerprint sweat accurately reflects codeine levels in blood and saliva. - The company plans to submit the PK study data as part of its 510(k) submission to the FDA by the end of the year. - The fingerprint drug screening technology is slated for potential launch in the US in 2025, targeting applications in law enforcement and forensics. - The study compared opiate levels in fingerprint sweat with blood, oral fluid, and urine, using liquid chromatography/tandem mass spectrometry for analysis.
- Intelligent Bio Solutions (INBS) reported positive results from its Pharmacokinetic (PK) study, a crucial step toward FDA 510(k) submission. - The study demonstrated that fingerprint sweat effectively mirrors codeine levels in blood and saliva, validating its reliability for drug detection. - INBS plans to launch its non-invasive drug screening technology in the US market in 2025, targeting safety-critical industries, pending FDA clearance. - The PK study involved 39 diverse subjects and utilized LC-MS/MS analysis, showing quantitative data closely aligned with blood samples at a 95% confidence level.
- Intelligent Bio Solutions is advancing in the FDA approval process for its rapid COVID-19 testing system, potentially offering a new point-of-care diagnostic tool. - The company's system aims to provide quick and accurate results, addressing the ongoing need for accessible and efficient COVID-19 testing solutions. - Successful FDA approval could significantly expand the availability of rapid COVID-19 testing, impacting public health and disease management strategies. - The advancement signals a step forward for Intelligent Bio Solutions in the diagnostics market, pending regulatory clearance and commercialization.
