$INBS Intelligent Bio Solutions Receives Guidance

$INBS Intelligent Bio Solutions Receives Guidance from U.S. FDA on a Regulatory Pathway for Expansion into the United States for its Intelligent Fingerprinting Drug Screening Cartridge


https://www.globenewswire.com/news-release/20...ridge.html

NEW YORK, June 28, 2023 (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 it has received guidance from the U.S. Food and Drug Administration (the “FDA”) regarding the regulatory classification of its Intelligent Fingerprinting Drug Screening Cartridge. The FDA has 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 preliminary assessment, in response to the Company’s March 2023 513(g) request for product classification, provides a clear regulatory pathway for INBS as part of the Company’s expansion strategy into the United States. The Company intends to submit a 510(k) pre-market notification for its proprietary Intelligent Fingerprinting Drug Screening Cartridge.

“We are pleased to receive the FDA’s preliminary assessment for our Intelligent Fingerprinting Drug Screening Cartridge, which is a key step in our expansion into the U.S. market,” said Harry Simeonidis, President and CEO of Intelligent Bio Solutions. “With its rapid collection time and portability, we believe our intelligent drug screening technology will redefine how U.S. workplaces approach testing by setting a new standard for drug testing procedures that prioritizes the dignity of employees while simultaneously enhancing operational efficiency for employers.”

The Intelligent Fingerprinting Drug Screening System is designed to detect the presence of specific drugs and/or their metabolites from fingerprint sweat. The system features a small, tamper-evident drug screening cartridge onto which ten fingerprint sweat samples are collected in less than a minute. The tamper-proof cartridges are designed to screen for multiple drug groups simultaneously, including combinations of opioids, cocaine, methamphetamines, benzodiazepines, cannabis, methadone, and buprenorphine, in an approach that offers a dignified, non-invasive, and rapid drug screening solution. The application of the technology in maintaining workplace safety has garnered positive feedback from the Company’s growing customer base of over 350 clients in other countries, successfully deterring substance abuse at work and ensuring employee well-being and compliance with health and safety policies.