Intelligent Bio Solutions Initiates Additional Clinical Studies for FDA 510(k) Submission Supporting Planned Entry into Multi-Billion Dollar U.S. Market

Intelligent Bio Solutions (Nasdaq: INBS) initiated clinical studies on Jan 28, 2026 to support an FDA 510(k) submission for its Intelligent Fingerprinting Drug Screening System targeting codeine detection.

Rhea-AI Summary

Intelligent Bio Solutions (Nasdaq: INBS) initiated clinical studies on Jan 28, 2026 to support an FDA 510(k) submission for its Intelligent Fingerprinting Drug Screening System targeting codeine detection.

The first cohort (40 adults) will use the DSR-Plus reader and fingerprint cartridges, include LC-MS/MS confirmation and predicate-device comparisons; full data analysis is expected by end of March 2026 for incorporation into the 510(k) package.

Positive

• Clinical study program commenced on Jan 28, 2026
• 40-subject first cohort to assess codeine detection cut-offs
• Full data analysis expected by end of March 2026
• 500,000 tests previously sold and used outside the U.S.

Negative

• First study limited to 40 adults, a small sample size
• Study results are pending and not yet in a 510(k)
• Current U.S. classification is Forensic Use Only, not cleared

Argus Jan 28 session

+2.93% close to close Open Argus

Details

News Market Reaction – INBS

In the Jan 28 session, INBS gained 2.93%, reflecting a moderate positive market reaction.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement outlines a focused clinical program supporting an FDA 510(k) submission for codein...

Analysis

This announcement outlines a focused clinical program supporting an FDA 510(k) submission for codeine detection using INBS’s non-invasive fingerprint platform. It follows recent financing, a 1-for-10 reverse split, and a resale registration covering 6,896,550 shares, all of which shape the capital structure alongside clinical progress. Investors may watch enrollment, data readout by end of March 2026, and subsequent FDA interactions as key markers for the U.S. market entry plan.

Key Figures

Sample size: 40 adults Data analysis timeline: End of March 2026 Tests sold: 500,000+ tests +5 more

Sample size

40 adults

First clinical study assessing codeine detection cut-off levels

Data analysis timeline

End of March 2026

Anticipated completion of full clinical data analysis for 510(k)

Tests sold

500,000+ tests

Fingerprinting drug screening tests sold and used outside the U.S.

Registered resale shares

6,896,550 shares

Shares of common stock covered by S-3 resale registration

Private placement proceeds

$10.0 million

Gross proceeds from December 31, 2025 private placement

Potential warrant cash

$18.87 million

Maximum proceeds if 6,791,550 warrant shares exercised for cash

Quarterly revenue

$1,111,797

Revenue for quarter ended September 30, 2025, up from $872,287

Net loss

$2,994,992

Net loss for quarter ended September 30, 2025

Historical Context

5 past events · Latest: Jan 02

5 events

1. Jan 02

   Private placement closing

   24h Move

   -17.2%

   Closed $10M at-the-market private placement with warrants, funding 510(k) work.

2. Dec 31

   Private placement deal

   24h Move

   +132.4%

   $10M at-the-market private placement agreement with additional warrant coverage.

3. Dec 31

   Manufacturing partnership

   24h Move

   +132.4%

   New manufacturing partner expected to cut costs and expand reader capacity.

4. Dec 18

   Strategic alliance

   24h Move

   +18.4%

   Non-exclusive partnership to extend non-invasive testing into consumer health.

5. Dec 12

   Reverse stock split

   24h Move

   -22.7%

   1-for-10 reverse split to address Nasdaq minimum bid price compliance.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

fda 510(k), drug screening, fluorescence reader, liquid chromatography-tandem mass spectrometry, +2 more

6 terms

fda 510(k) regulatory

"support its new FDA 510(k) submission for U.S. market clearance"

A FDA 510(k) is a premarket notification a medical device maker files to show a new device is similar enough to an already approved device that it can be marketed without a lengthy review. For investors it matters because a cleared 510(k) offers a faster, lower-cost path to sell a product and reduces regulatory uncertainty—think of it like proving you’re using an approved recipe rather than inventing a brand-new one.

drug screening medical

"world’s largest drug screening market Company anticipates full data"

Drug screening is a medical test that checks biological samples (like blood or urine) for the presence of prescription, over‑the‑counter, or illegal substances. For investors, these tests matter because results affect clinical trial safety, regulatory approval, workplace compliance and legal risk—much like a security checkpoint that determines whether a product or program can proceed safely and legally to market and operation.

fluorescence reader technical

"Drug Screening Cartridge with the DSR-Plus fluorescence reader, together"

A fluorescence reader is a laboratory instrument that detects and measures light emitted by dyed or naturally glowing molecules in a sample — like a sensitive camera that sees a faint glow to reveal what’s present and in what amount. Investors pay attention because these devices power many diagnostic tests, research studies and drug‑development assays; sales and recurring supply purchases can indicate growing demand, regulatory progress, or commercial uptake of new tests.

liquid chromatography-tandem mass spectrometry medical

"Results will be corroborated via a liquid chromatography-tandem mass"

Liquid chromatography-tandem mass spectrometry is a laboratory method that first separates a mixture of chemicals in liquid form and then identifies and measures each component by its weight, like first sorting beads by color and then weighing each pile. Investors care because it provides highly precise, trusted data used in drug development, safety testing and quality control; those results influence regulatory approvals, product reliability, timelines and financial risk for companies.

lc-ms/ms medical

"liquid chromatography-tandem mass spectrometry (“LC-MS/MS”) analysis."

LC‑MS/MS is a laboratory technique that first separates a mixture of chemicals in a liquid, then identifies and measures each component with very high sensitivity—think of sorting mixed mail and then scanning barcodes to know exactly what’s inside. It matters to investors because it produces precise, reliable data used in drug development, safety testing, diagnostics and product quality control, and those results influence regulatory approvals, market access and commercial claims that can affect a company’s value.

forensic use only regulatory

"enter the U.S. market beyond the Forensic Use Only category."

A label meaning a test, device, or kit is intended only for legal, investigative, or quality-control purposes and not for diagnosing or treating patients. Think of it like a tool stamped “for museum display only” — it may prove something in court or help investigators, but it cannot be used by doctors for medical decisions; that limitation affects who can buy it, how it’s reimbursed, and its commercial value.

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Clinical studies designed to support FDA clearance and planned commercial launch into the world’s largest drug screening market 

Company anticipates full data analysis by the end of March 2026; data to be incorporated into FDA 510(k) submission package

NEW YORK, Jan. 28, 2026 (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 the commencement of its clinical study program to support its new FDA 510(k) submission for U.S. market clearance of its Intelligent Fingerprinting Drug Screening System for detection of the opiate codeine.

As part of its clinical study program, the Company has again partnered with Cliantha Research, a leading clinical research organization, leveraging its extensive regulatory and clinical trial expertise.

The first clinical study will assess codeine detection cut-off levels in 40 adults at a single site. The study will utilize the Intelligent Fingerprinting Drug Screening Cartridge with the DSR-Plus fluorescence reader, together forming the Company's non-invasive Intelligent Fingerprinting Drug Screening System. Participants will receive controlled doses of codeine, with sample collection and analysis conducted to establish and verify optimal detection cut-off levels. The study design includes direct comparisons with a predicate FDA-cleared device to support the 510(k) regulatory pathway. Results will be corroborated via a liquid chromatography-tandem mass spectrometry (“LC-MS/MS”) analysis. This clinical approach is designed to support both the Company's U.S. regulatory pathway and commercial strategy to enter the U.S. market beyond the Forensic Use Only category. 

The U.S. drug screening market represents a substantial commercial opportunity, generating several billions of dollars annually across workplace testing, criminal justice applications, pain management, and substance abuse treatment settings. The Company's non-invasive fingerprint-based technology offers significant advantages over traditional urine, oral fluid, and blood testing methods, including improved hygiene, ease of use, rapid results, and reduced collection costs.

"Obtaining FDA clearance for the U.S. market is a major opportunity for Intelligent Bio Solutions,” said Harry Simeonidis, President and CEO at Intelligent Bio Solutions. "The U.S. drug screening market is the largest and most sophisticated in the world, and our Intelligent Fingerprinting technology is uniquely positioned to address unmet needs across multiple high-value segments, including workplace testing, clinical settings, and law enforcement applications. Initiating our clinical studies marks a pivotal moment for our company and the customers we aim to serve. This milestone reflects years of rigorous scientific development and dedication from our team. It will further demonstrate the proven performance of our technology, with over 500,000 tests already sold and used outside the U.S. We look forward to completing these trials and compiling the results as part of our overall FDA submission.”

Cliantha has initiated subject recruiting and screening, with the first testing cohort scheduled to begin on January 28, 2026, and full data analysis anticipated by the end of March 2026. The Company plans to incorporate this clinical data into its new FDA 510(k) submission package.

About Intelligent Bio Solutions Inc.

Intelligent Bio Solutions Inc. (NASDAQ: INBS) is a medical technology company delivering intelligent, 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, mining, drug treatment organizations, and coroners.

For more information, visit: https://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, and involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, statements regarding Intelligent Bio Solutions Inc.’s ability to successfully develop and commercialize its drug and diagnostic tests, realize commercial benefits from its partnerships and collaborations, and secure regulatory clearance or 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, actual results may differ materially from those expressed or implied by such 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,” and “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, including those described in Intelligent Bio Solutions’ public filings with the U.S. Securities and Exchange Commission. Any forward-looking statements contained in this release speak only as of the date of this release. 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 & Media Contact
Valter Pinto, Managing Director
KCSA Strategic Communications
PH: (212) 896-1254
INBS@kcsa.com

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What clinical studies did Intelligent Bio Solutions (INBS) start on January 28, 2026?

The company started a clinical study assessing codeine detection cut-offs in 40 adults using its fingerprint cartridge and DSR-Plus reader. According to the company, the trial includes LC-MS/MS confirmation and comparisons to a predicate FDA-cleared device for 510(k) support.

When will Intelligent Bio Solutions (INBS) have clinical data for the FDA 510(k) submission?

Full data analysis is anticipated by the end of March 2026 for incorporation into the 510(k) package. According to the company, Cliantha Research is recruiting subjects and will run the cohorts to compile results for submission.

How does Intelligent Fingerprinting technology factor into INBS's U.S. commercial plan?

INBS plans to use its non-invasive fingerprint drug screening system to enter the U.S. market beyond Forensic Use Only. According to the company, the technology aims to offer rapid results, lower collection costs, and improved hygiene for multiple testing settings.

What validation methods will Intelligent Bio Solutions (INBS) use in the codeine study?

The study will use LC-MS/MS confirmation and direct comparison to a predicate FDA-cleared device for validation. According to the company, these methods are intended to establish optimal detection cut-offs for 510(k) regulatory support.

Does Intelligent Bio Solutions (INBS) have prior commercial use of its tests outside the U.S.?

Yes, the company has sold and deployed over 500,000 tests outside the United States. According to the company, that prior usage supports performance claims as it seeks FDA clearance for U.S. commercialization.

What market opportunity is INBS targeting with its FDA 510(k) program?

INBS is targeting the multi-billion dollar U.S. drug screening market across workplace, criminal justice, clinical, and treatment settings. According to the company, FDA clearance would enable market entry beyond the current Forensic Use Only category.