Intelligent Bio Solutions' Fingerprint Drug Screening System on Track for 2025 FDA Clearance
• 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 Secures Sixth U.S. Patent for Fingerprint Drug Screening Technology
• 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 Advances Fingerprint Drug Screening Tech Towards FDA Approval
• 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' Fingerprint Sweat Analysis Shows Promise in Drug Detection
• 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 Progresses in FDA Approval Process for its COVID-19 Testing System
• 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.
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