Intelligent Bio Solutions’ FDA Clearance Process Remains on Track for 2025 U.S. Launch

Rhea-AI Summary

Intelligent Bio Solutions (NASDAQ: INBS) provided an update on its FDA clearance process for the Intelligent Fingerprint Drug Screening System, confirming its planned 2025 U.S. launch remains on track. The company submitted its 510(k) premarket notification on December 18, 2024, for its opiate test system, classified as a Class II device.

The submission included performance data showing 94.1% accuracy and Pharmacokinetic (PK) study results demonstrating fingerprint sweat's reliability for drug detection. The FDA has issued an Additional Information (AI) request, temporarily pausing the 90-day review period. While FDA clearance typically takes 3-6 months, the process may extend if additional data is required.

The system is currently operational in 19 countries with over 400 accounts globally. INBS plans to pursue FDA clearance for additional drug classes on its panel while preparing for entry into the U.S. market.

Positive

• 94.1% accuracy demonstrated in method comparison study
• Strong global presence with 400+ accounts across 19 countries
• FDA clearance process progressing as expected
• PK study showed reliable correlation with blood test results

Negative

• FDA review timeline extended due to Additional Information request
• Current submission to opiate test system only, requiring additional submissions for other drug classes

Insights

Medical Device Regulatory Analyst

Intelligent Bio Solutions' FDA clearance update provides a neutral development in their regulatory pathway. The company has submitted its 510(k) application for the Intelligent Fingerprint Drug Screening System and has received an Additional Information (AI) request from the FDA - a standard part of the review process that temporarily pauses the 90-day review clock.

The company's fingerprint-based opiate test system has demonstrated 94.1% accuracy in their method comparison study, with their Pharmacokinetic study showing statistical alignment with blood samples at the 95% confidence level. These metrics suggest their technology performs well, though FDA clearance isn't guaranteed until the agency completes its full review.

The timeline characterization of "on track for 2025 launch" appears realistic given the current regulatory stage. FDA clearance processes typically take 3-6 months when AI requests are involved, aligning with the company's projection. The fact that the product is already commercialized in 19 countries provides some validation of its market readiness, though U.S. regulatory standards have different requirements.

This update represents a procedural milestone rather than a definitive regulatory achievement. The company must still satisfy the FDA's additional information request before the review clock restarts, and successful clearance remains contingent on the agency's final determination.

NEW YORK, March 25, 2025 (GLOBE NEWSWIRE) -- Intelligent Bio Solutions Inc. (Nasdaq: INBS) (“INBS” or the “Company”), a medical technology company delivering intelligent, rapid, non-invasive testing solutions, today provided shareholders with a status update on the FDA clearance process for its Intelligent Fingerprint Drug Screening System, which remains on track for launch in the U.S. in 2025 targeting its opiate test system for codeine, as validated in the Company’s Pharmacokinetic (PK) study.

On December 18, 2024, the Company announced the submission of its 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for review and clearance of its Intelligent Fingerprinting Drug Screening System, which the FDA classified as a 21 CFR 862.3650, Opiate Test System, a Class II device requiring submission of a 510(k) premarket notification. This submission marked a critical milestone in the Company’s efforts to enter the U.S. market with its drug testing system in 2025.

The Company's 510(k) submission included performance data and validation studies, including a method comparison study that demonstrated the system’s 94.1% accuracy and a PK study that showed fingerprint sweat provides a reliable sample matrix for drug detection, with quantitative PK data closely aligned to blood, based on statistical comparisons made at the 95% confidence level. These findings highlight the system's accuracy, reliability, and usability, demonstrating its capacity to meet the growing demand for efficient, non-invasive testing solutions in the U.S. market.

INBS’s 510(k) submission started the 90-day period within which the FDA is required to review and respond to 510(k) submissions. As expected, the FDA has reviewed and responded with questions by issuing an Additional Information (AI) request. When the FDA issues an AI request, the 90-day review clock is paused. The Company has reviewed the AI request and is in the process of responding so that the FDA can restart the review clock. As a result of this process, although the FDA is required to review and respond in 90 days, it is not uncommon for the FDA clearance process to take three to six months or longer if additional data is required. As INBS awaits FDA clearance, it continues to develop its plans to enter the multi-billion-dollar U.S. market in 2025 and pursue FDA clearance for additional drug classes on its panel. The Company’s full panel test is already widely adopted, with a presence in 19 countries and over 400 accounts globally.

"The submission of our 510(k) premarket notification to the FDA marked a pivotal step in the journey to bring our Intelligent Fingerprint Drug Screening System to the U.S. market," said Harry Simeonidis, President and CEO at INBS. "We appreciate the thoroughness of the FDA’s process, which aligns with our expectations. As we await FDA clearance, we remain confident in the strength of our data, which demonstrates the accuracy, reliability, and usability of our technology. We are actively preparing for our planned U.S. launch in 2025, where we see significant opportunities to revolutionize drug screening with our non-invasive, rapid testing solution."

About Intelligent Bio Solutions Inc. 

Intelligent Bio Solutions Inc. (NASDAQ: INBS) is a medical technology company delivering innovative, rapid, non-invasive testing solutions. The Company believes that its Intelligent Fingerprinting Drug Screening System will revolutionize portable testing through fingerprint sweat analysis, which has the potential for broader applications in additional fields. Designed as a hygienic and cost-effective system, the test screens for the recent use of drugs commonly found in the workplace, including opiates, cocaine, methamphetamine, and cannabis. With sample collection in seconds and results in under ten minutes, this technology would be a valuable tool for employers in safety-critical industries. The Company’s current customer segments outside the U.S. include construction, manufacturing and engineering, transport and logistics firms, drug treatment organizations, and coroners.

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 drug and 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   
LinkedIn | Twitter  

Investor & Media Contact:  
Valter Pinto, Managing Director  
KCSA Strategic Communications  
PH: (212) 896-1254  
INBS@kcsa.com

FAQ

What accuracy rate did INBS's Intelligent Fingerprint Drug Screening System demonstrate in trials?

The system demonstrated 94.1% accuracy in its method comparison study, with PK data aligning with blood results at a 95% confidence level.

When did INBS submit its 510(k) application to the FDA?

INBS submitted its 510(k) premarket notification to the FDA on December 18, 2024.

What is the current global presence of INBS's drug screening system?

The system is currently present in 19 countries with over 400 accounts globally.

What type of FDA classification did INBS's drug screening system receive?

The system was classified as a 21 CFR 862.3650 Opiate Test System, a Class II device requiring 510(k) premarket notification.

When does INBS expect to launch its drug screening system in the US market?

INBS plans to launch its drug screening system in the U.S. market in 2025, pending FDA clearance.