Intelligent Bio Solutions Inc. partners with Cliantha Research for a pharmacokinetic study as part of FDA 510(k) pathway. The study, recruiting 40 subjects, aims to compare opiate levels in fingerprint sweat with blood, oral fluid, and urine specimens. This milestone marks progress toward FDA clearance for Intelligent Bio Solutions’ innovative drug screening cartridge.
Intelligent Bio Solutions Inc. (Nasdaq: INBS), a leading medical technology company specializing in intelligent, rapid, and non-invasive testing solutions, has announced a strategic collaboration with Cliantha Research, a renowned Clinical Research Organization (CRO). This partnership aims to conduct a pharmacokinetic (PK) study as part of Intelligent Bio Solutions’ FDA 510(k) clinical study plan.
The PK study will involve recruiting 40 healthy adult subjects under an IRB/EC and regulatory-approved protocol. The study will compare the levels of opiates in fingerprint sweat with those in blood, oral fluid, and urine specimens following the supervised administration of drugs. All specimens will undergo analysis using a validated liquid chromatography mass spectrometry (LC-MS/MS) method, recognized as the gold standard for such investigations. Fingerprint sweat specimens will be assessed using Intelligent Bio Solutions’ Intelligent Fingerprinting Drug Screening System, including the Drug Screening Cartridge and DSR-Plus fluorescence reader, and compared with LC-MS/MS results.
Commencing the clinical study plan marks a significant milestone for Intelligent Bio Solutions as it progresses along the 510(k) pathway. Harry Simeonidis, President and CEO of Intelligent Bio Solutions, expressed satisfaction with the partnership and the company’s advancement, stating, “Initiating our clinical studies plan represents a critical milestone for our organization. We have developed a detailed plan that we are committed to executing, and while there is considerable work ahead, we have taken the crucial first step in this process.”
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Dr. Anne Marie Salapatek, Chief Scientific Officer and Executive Vice President at Cliantha Research, expressed excitement about commencing the clinical trial to test the innovative device’s efficacy in providing rapid and non-invasive testing for opiates.
Following guidance received from the FDA in June 2023 regarding the regulatory classification of the Intelligent Fingerprinting Drug Screening Cartridge, the company intends to demonstrate through the PK study that fingerprint sweat measurement serves as a suitable proxy for measurements obtained from blood, oral fluid, or urine specimens to detect the presence of opiates.
Recruitment and screening of subjects for the PK study are expected to occur in March and April 2024, with studies slated to commence in May 2024. Sample analysis is projected to conclude by the end of June 2024.
