$INBS Intelligent Bio Solutions Partners with CenExel to Conduct Clinical Study as Part of FDA 510(k) Pathway
https://www.globenewswire.com/news-release/20...thway.html
NEW YORK, Aug. 01, 2024 (GLOBE NEWSWIRE) -- Intelligent Bio Solutions Inc. (Nasdaq: INBS) ("INBS" or the "Company"
, a medical technology company delivering intelligent, rapid, non-invasive testing solutions, today announced its partnership with CenExel, a nationwide clinical research site network, to perform a method comparison clinical study as part of the Company’s FDA 510(k) clinical study plan.
The Company’s method comparison study will recruit 135 healthy adult subjects across three sites under an IRB-approved protocol and compare the results of fingerprint sweat opiate screening tests to the results from a validated, traceable liquid chromatography mass spectrometry (LC-MS/MS) method, widely accepted as the gold standard for such studies.
Harry Simeonidis, President and CEO of Intelligent Bio Solutions, commented, “We are pleased to announce our partnership with CenExel and the initiation of the method comparison study, marking the final phase in our clinical study plan. Over the past two months, we have made substantial progress and are steadily getting closer to filing our 510(k) submission with the FDA. We remain on track for our planned submission to the FDA in the fourth quarter of this calendar year. I commend our dedicated team and clinical study partners for their immense effort and commitment to ensuring the smooth execution of our clinical study plan.” Stuart Goldblatt, Chief Executive Officer at CenExel, stated, “CenExel is excited to commence this clinical trial to test this innovative device with the potential to provide rapid and non-invasive testing for opiates.”
The Company recently completed the in-clinic portion of a pharmacokinetic (PK) study on opiates in human fingerprint sweat. Through the method comparison study, the Company intends to demonstrate that the Intelligent Fingerprinting Drug Screening System, which comprises the Intelligent Fingerprinting Drug Screening Cartridge and DSR-Plus fluorescence reader, performs accurately in the hands of intended users to detect the presence of opiates. The Company plans to commence the method comparison study in August 2024.
https://www.globenewswire.com/news-release/20...thway.html
NEW YORK, Aug. 01, 2024 (GLOBE NEWSWIRE) -- Intelligent Bio Solutions Inc. (Nasdaq: INBS) ("INBS" or the "Company"
, a medical technology company delivering intelligent, rapid, non-invasive testing solutions, today announced its partnership with CenExel, a nationwide clinical research site network, to perform a method comparison clinical study as part of the Company’s FDA 510(k) clinical study plan. The Company’s method comparison study will recruit 135 healthy adult subjects across three sites under an IRB-approved protocol and compare the results of fingerprint sweat opiate screening tests to the results from a validated, traceable liquid chromatography mass spectrometry (LC-MS/MS) method, widely accepted as the gold standard for such studies.
Harry Simeonidis, President and CEO of Intelligent Bio Solutions, commented, “We are pleased to announce our partnership with CenExel and the initiation of the method comparison study, marking the final phase in our clinical study plan. Over the past two months, we have made substantial progress and are steadily getting closer to filing our 510(k) submission with the FDA. We remain on track for our planned submission to the FDA in the fourth quarter of this calendar year. I commend our dedicated team and clinical study partners for their immense effort and commitment to ensuring the smooth execution of our clinical study plan.” Stuart Goldblatt, Chief Executive Officer at CenExel, stated, “CenExel is excited to commence this clinical trial to test this innovative device with the potential to provide rapid and non-invasive testing for opiates.”
The Company recently completed the in-clinic portion of a pharmacokinetic (PK) study on opiates in human fingerprint sweat. Through the method comparison study, the Company intends to demonstrate that the Intelligent Fingerprinting Drug Screening System, which comprises the Intelligent Fingerprinting Drug Screening Cartridge and DSR-Plus fluorescence reader, performs accurately in the hands of intended users to detect the presence of opiates. The Company plans to commence the method comparison study in August 2024.
