Intelligent Bio Solutions Inc. files FDA 513(g) regulatory submission for Intelligent Fingerprinting Drug Screening Cartridge

Rhea-AI Summary

Intelligent Bio Solutions Inc. (Nasdaq: INBS) announced the filing of a 513(g) submission with the FDA for its Intelligent Fingerprinting Drug Screening Cartridge. This submission aims to identify the most suitable regulatory pathway as part of the company’s U.S. expansion strategy. The cartridge detects four drugs from fingerprint sweat in under ten minutes, emphasizing a quick and non-invasive testing process.

CEO Harry Simeonidis highlighted that this development is crucial in combating drug abuse and enhancing workplace safety.

Positive

• Filed 513(g) submission for FDA approval, indicating progress in U.S. market expansion.
• The Intelligent Fingerprinting Drug Screening Cartridge offers quick and non-invasive drug testing, addressing safety in workplaces.

Negative

• None.

- 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 sweat -

NEW YORK, Feb. 16, 2023 (GLOBE NEWSWIRE) -- 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. 

"This 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."

The 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.

About Intelligent Bio Solutions Inc.

Intelligent 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.

For more information, visit http://www.ibs.inc/

Forward-Looking Statements:

Some 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.

Company Contact:
Intelligent Bio Solutions Inc.
info@ibs.inc

Investor Contact:
Valter Pinto
KCSA Strategic Communications
INBS@kcsa.com

Media Contact:
Cheryl Billson
Comma Communications
cheryl.billson@commacomms.com

FAQ

What is the purpose of the 513(g) submission by Intelligent Bio Solutions Inc.?

The 513(g) submission aims to determine the appropriate FDA regulatory pathway for the Intelligent Fingerprinting Drug Screening Cartridge as part of the company's U.S. expansion.

What drugs can the Intelligent Fingerprinting Drug Screening Cartridge detect?

The cartridge can detect opiates, methamphetamine, cocaine, and THC (the active ingredient in cannabis) from fingerprint sweat.

How quickly can results be obtained from the Intelligent Fingerprinting Drug Screening test?

Results from the Intelligent Fingerprinting Drug Screening test can be obtained in under ten minutes.

What is the significance of the Intelligent Fingerprinting Drug Screening Cartridge for workplaces?

The cartridge facilitates broader drug screening adoption, which can promote a safer work environment by addressing drug abuse challenges.

What is the stock symbol for Intelligent Bio Solutions Inc.?

The stock symbol for Intelligent Bio Solutions Inc. is INBS.