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Intelligent Bio Solutions | 8-K: Current report

SEC ·  Sep 6, 2024 05:18

Summary by Futu AI

Intelligent Bio Solutions has made significant progress in its FDA 510(k) submission process, completing approximately one-third of subject enrollment for its method comparison study. The study, conducted in partnership with CenExel, aims to recruit 135 healthy adults across three sites to compare fingerprint sweat opiate screening tests with LC-MS/MS laboratory methods.The company has also completed the in-clinic portion of a pharmacokinetic study on opiates in human fingerprint sweat, with specimen and data analysis currently underway. According to CEO Harry Simeonidis, the company remains on track to complete the in-clinic portion of the method comparison study by September end, targeting FDA 510(k) submission in Q4 2024.The clinical studies aim to demonstrate the effectiveness and accuracy of the Intelligent Fingerprinting Drug Screening System, which offers rapid, non-invasive drug testing through fingerprint sweat analysis. The system is designed to detect common workplace drugs including opiates, cocaine, methamphetamine, and cannabis, with results available in under ten minutes.
Intelligent Bio Solutions has made significant progress in its FDA 510(k) submission process, completing approximately one-third of subject enrollment for its method comparison study. The study, conducted in partnership with CenExel, aims to recruit 135 healthy adults across three sites to compare fingerprint sweat opiate screening tests with LC-MS/MS laboratory methods.The company has also completed the in-clinic portion of a pharmacokinetic study on opiates in human fingerprint sweat, with specimen and data analysis currently underway. According to CEO Harry Simeonidis, the company remains on track to complete the in-clinic portion of the method comparison study by September end, targeting FDA 510(k) submission in Q4 2024.The clinical studies aim to demonstrate the effectiveness and accuracy of the Intelligent Fingerprinting Drug Screening System, which offers rapid, non-invasive drug testing through fingerprint sweat analysis. The system is designed to detect common workplace drugs including opiates, cocaine, methamphetamine, and cannabis, with results available in under ten minutes.

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