Full Press Release Details
Bio Solutions Inc. files FDA 513(g) regulatory submission for
Fingerprinting Drug Screening Cartridge
513(g) submission will allow Intelligent Bio Solutions Inc. to determine the most suitable FDA regulatory pathway for its Intelligent
Fingerprinting Drug Screening Cartridge, as the next step in its expansion strategy into the U.S. -
Intelligent Fingerprinting Drug Screening Cartridge quickly detects the presence of four drugs and/or their metabolites from fingerprint
York, NY, February 16, 2023 - Intelligent Bio Solutions Inc. ("Intelligent Bio Solutions" or the "Company")
(Nasdaq: INBS), a life sciences company developing and delivering intelligent, non-invasive, real-time testing solutions, today announced
that the Company has filed a 513(g) submission with the United States Food and Drug Administration (FDA) for its Intelligent Fingerprinting
Drug Screening Cartridge. The submission will allow Intelligent Bio Solutions to determine the most suitable FDA regulatory pathway as
part of the Company's strategy for expansion into the U.S. market.
is a significant step that marks the commencement of our expansion into the United States," said Harry Simeonidis, Chief Executive
Officer at Intelligent Bio Solutions. "Our goal is to help address the increasing tide of drug abuse challenges by providing
a proven, non-invasive, affordable and easy-to-use product that facilitates the broader adoption of drug screening, thereby promoting
a safer work environment."
Intelligent Fingerprinting Drug Screening test detects the presence of four drugs and/or their metabolites from fingerprint sweat. The
drug testing system features a small, tamper-evident drug screening cartridge onto which ten fingerprint sweat samples are collected
in a process that takes less than a minute. The rapid test detects combinations of opiates, methamphetamine, cocaine, and the active
ingredient in cannabis: delta-9-tetrahydrocannabinol (THC), in under ten minutes.
Intelligent Bio Solutions Inc.
Bio Solutions Inc. is a life sciences company developing and delivering intelligent, non-invasive, real-time testing solutions to customers
globally. With its world-first biosensor platform, Intelligent Bio Solutions is developing and launching diagnostic tests urgently needed
to help people living with chronic disease. In addition, through its recent acquisition of Intelligent Fingerprinting Limited, the Company
is the world leader in the advancement of portable drugs of abuse testing through the analysis of fingerprint sweat. The system is a
platform technology with potential applications in many areas of diagnostics, and its advantages include being non-invasive, hygienic,
fast, and cost-effective. The top-selling product screens for recent use of the most commonly taken drugs in workplace settings; opioids,
cocaine, methamphetamine, and marijuana. Sample collection takes just seconds, with results in ten minutes. Customers include employers
in safety-critical industries such as construction, transport and logistics firms, drug treatment organizations, and UK coroners. A laboratory
confirmation service is also available.
more information, visit http://www.ibs.inc/
of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section
21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties.
Forward-looking statements in this press release include, without limitation, Intelligent Bio Solutions Inc.'s ability to successfully
develop and commercialize its diagnostic tests, realize commercial benefit from its partnerships and collaborations, and secure regulatory
approvals, among others. Although Intelligent Bio Solutions Inc. believes that the expectations reflected in such forward-looking statements
are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by
such forward-looking statements. Intelligent Bio Solutions Inc. has attempted to identify forward-looking statements by terminology,
including "believes," "estimates," "anticipates," "expects," "plans," "projects,"
"intends," "potential," "may," "could," "might," "will," "should,"
"approximately" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements.
These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, included in Intelligent
Bio Solutions' public filings filed with the Securities and Exchange Commission. Any forward-looking statements contained in this
release speak only as of its date. Intelligent Bio Solutions undertakes no obligation to update any forward-looking statements contained
in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.
Strategic Communications