$INBS Intelligent Bio Solutions Partners with Cliantha Research to Conduct Clinical Study as Part of FDA 510(k) Pathway
https://www.globenewswire.com/news-release/20...thway.html
NEW YORK, Feb. 28, 2024 (GLOBE NEWSWIRE) -- Intelligent Bio Solutions Inc. ("INBS" or the "Company"
(Nasdaq: INBS), a medical technology company delivering intelligent, rapid, non-invasive testing solutions, today announced its partnership with Cliantha Research, a full-service Clinical Research Organization (CRO), to perform a pharmacokinetic (PK) study forming part of the Company’s FDA 510(k) clinical study plan.
The Company’s PK study will recruit 40 healthy adult subjects under an IRB/EC and regulatory approved protocol and compare the amounts of opiates in fingerprint sweat versus blood, oral fluid and urine specimens following the medically supervised administration of drugs. All fingerprint sweat, blood, oral fluid and urine specimens will be analyzed by a validated, traceable liquid chromatography mass spectrometry (LC-MS/MS) method, widely accepted as the gold standard for such studies. The fingerprint sweat specimen will be screened using INBS’ Intelligent Fingerprinting Drug Screening System comprising the Intelligent Fingerprinting Drug Screening Cartridge and DSR-Plus fluorescence reader and compared to the LC-MS/MS results.
The start of the clinical study plan marks an exciting milestone for the Company as it advances on its 510(k) pathway. Harry Simeonidis, President and CEO at Intelligent Bio Solutions, commented, “We are pleased to share news of our partnership with Cliantha and progress on our 510(k) journey. 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. Our focus is on ensuring we remain on track for our planned entry into the US market and expand access to our innovative screening solution.” Dr Anne Marie Salapatek, Chief Scientific Officer and Executive Vice President at Cliantha Research, stated, “At Cliantha, we are excited to commence this rigorous and controlled clinical trial to test this innovative device with potential to provide rapid and non-invasive testing for opiates.”
In June 2023, the Company announced it had received guidance from the FDA regarding the regulatory classification of its Intelligent Fingerprinting Drug Screening Cartridge. The FDA provisionally determined that the cartridge falls within 21 CFR 862.3650, Opiate Test System, a Class II type device that requires the submission of a pre-market notification 510(k) and the FDA’s clearance prior to marketing.
The Company intends to demonstrate through the PK study that the fingerprint sweat measurement is 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 anticipated to take place in March and April 2024, with studies set to begin in May 2024. Sample analysis is projected to conclude by the end of June 2024.
https://www.globenewswire.com/news-release/20...thway.html
NEW YORK, Feb. 28, 2024 (GLOBE NEWSWIRE) -- Intelligent Bio Solutions Inc. ("INBS" or the "Company"
(Nasdaq: INBS), a medical technology company delivering intelligent, rapid, non-invasive testing solutions, today announced its partnership with Cliantha Research, a full-service Clinical Research Organization (CRO), to perform a pharmacokinetic (PK) study forming part of the Company’s FDA 510(k) clinical study plan. The Company’s PK study will recruit 40 healthy adult subjects under an IRB/EC and regulatory approved protocol and compare the amounts of opiates in fingerprint sweat versus blood, oral fluid and urine specimens following the medically supervised administration of drugs. All fingerprint sweat, blood, oral fluid and urine specimens will be analyzed by a validated, traceable liquid chromatography mass spectrometry (LC-MS/MS) method, widely accepted as the gold standard for such studies. The fingerprint sweat specimen will be screened using INBS’ Intelligent Fingerprinting Drug Screening System comprising the Intelligent Fingerprinting Drug Screening Cartridge and DSR-Plus fluorescence reader and compared to the LC-MS/MS results.
The start of the clinical study plan marks an exciting milestone for the Company as it advances on its 510(k) pathway. Harry Simeonidis, President and CEO at Intelligent Bio Solutions, commented, “We are pleased to share news of our partnership with Cliantha and progress on our 510(k) journey. 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. Our focus is on ensuring we remain on track for our planned entry into the US market and expand access to our innovative screening solution.” Dr Anne Marie Salapatek, Chief Scientific Officer and Executive Vice President at Cliantha Research, stated, “At Cliantha, we are excited to commence this rigorous and controlled clinical trial to test this innovative device with potential to provide rapid and non-invasive testing for opiates.”
In June 2023, the Company announced it had received guidance from the FDA regarding the regulatory classification of its Intelligent Fingerprinting Drug Screening Cartridge. The FDA provisionally determined that the cartridge falls within 21 CFR 862.3650, Opiate Test System, a Class II type device that requires the submission of a pre-market notification 510(k) and the FDA’s clearance prior to marketing.
The Company intends to demonstrate through the PK study that the fingerprint sweat measurement is 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 anticipated to take place in March and April 2024, with studies set to begin in May 2024. Sample analysis is projected to conclude by the end of June 2024.
