Intelligent Bio Solutions Initiates Clinical Study Supporting FDA Clearance and Planned U.S. Market Entry

Intelligent Bio Solutions (Nasdaq: INBS) has initiated an Interference Study to support FDA 510(k) clearance and planned U.S. market entry of its Intelligent Fingerprinting Drug Screening System for detecting the opiate codeine.

Rhea-AI Summary

Intelligent Bio Solutions (Nasdaq: INBS) has initiated an Interference Study to support FDA 510(k) clearance and planned U.S. market entry of its Intelligent Fingerprinting Drug Screening System for detecting the opiate codeine.

The study, conducted with CenExel Clinical Research, will enroll 75 healthy adults under undosed and dosed conditions. It will evaluate how handling everyday potentially interfering substances affects test specificity and accuracy, using LC-MS/MS confirmation. Completion is expected by mid-July 2026, with results included in the FDA 510(k) submission alongside a Cut-off Study and a Method Comparison Study.

Argus Jun 16 session

-1.29% close to close Open Argus

Details

News Market Reaction – INBS

In the Jun 16 session, INBS declined 1.29%, reflecting a mild negative market reaction.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement advances INBS’s FDA 510(k) strategy by adding an interference study with 75 partic...

Analysis

This announcement advances INBS’s FDA 510(k) strategy by adding an interference study with 75 participants to validate specificity of its fingerprint-based codeine test under real-world conditions. Together with the ongoing Method Comparison Study and prior PK work, it deepens the clinical package. Investors should contextualize this progress against recent filings that flag continued losses, going-concern risk, active ATM capacity of $3,966,316, and a resale registration for 6,896,550 shares.

Key Figures

Interference Study size: 75 healthy adult participants Method Comparison enrollment: 135 donors Q3 2026 revenue: $1.06 million +5 more

Interference Study size

75 healthy adult participants

Codeine interference study for 510(k) package

Method Comparison enrollment

135 donors

Multi-site Method Comparison Study supporting 510(k)

Q3 2026 revenue

$1.06 million

Fiscal Q3 2026 results (8-K/10-Q)

Revenue growth

46% year-over-year

Fiscal Q3 2026 revenue growth

Cash and equivalents

$6.86 million

As of March 31, 2026 (10-Q)

Registered resale shares

6,896,550 shares

S-3 resale registration from Dec 31, 2025 placement

Public float

$18,572,023

ATM prospectus based on March 23, 2026 data

ATM capacity

$3,966,316

Remaining under ATM Agreement as of March 23, 2026

Previous Clinical trial,fda approval Reports

4 past events · Latest: Jun 11

Same Type 4 events

1. Jun 11

   Forensic market expansion

   24h Move

   +8.5%

   Reported U.S. forensic adoption progress while pursuing FDA clearance for codeine assay.

2. Mar 25

   FDA process update

   24h Move

   -16.6%

   Confirmed 2025 U.S. launch track and detailed 510(k) accuracy data and FDA AI request.

3. Sep 27

   Clinical testing completion

   24h Move

   -1.6%

   Completed in-clinic PK and method comparison studies ahead of 510(k) submission.

4. Sep 05

   Study plan progress

   24h Move

   -0.8%

   Reported enrollment progress and PK work for studies supporting 510(k) filing.

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), liquid chromatography-tandem mass spectrometry, lc-ms/ms, ich gcp, +3 more

7 terms

fda 510(k) regulatory

"plans to include results in its FDA 510(k) submission package"

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.

liquid chromatography-tandem mass spectrometry medical

"results confirmed via liquid chromatography-tandem mass spectrometry"

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

"results confirmed via liquid chromatography-tandem mass spectrometry (“LC-MS/MS”)"

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.

ich gcp medical

"The study will follow FDA guidance and ICH GCP (International Council for Harmonisation Good Clinical Practice)"

An international set of standards that describes how clinical trials should be designed, conducted, recorded and reported to protect people taking part and to ensure the data are reliable. Think of it like a safety checklist and blueprint for medical studies: when companies follow it, regulators and investors can trust the results; when they don’t, trials can be delayed, rejected or lead to legal and financial risks that affect a company’s value.

good clinical practice medical

"ICH GCP (International Council for Harmonisation Good Clinical Practice) Guidelines"

Good clinical practice is a global set of ethical and scientific rules for designing, conducting, recording, and reporting clinical trials so that participant safety is protected and results are reliable. For investors, adherence to these rules is like following a strict recipe and inspection checklist: it reduces the risk that trial data will be rejected by regulators, delays approval, or causes costly rework, and therefore affects a company’s timeline, costs, and credibility.

opiate medical

"Drug Screening System for detection of the opiate codeine"

Opiate is a class of drugs derived from the opium poppy—such as morphine and codeine—that relieve pain by acting on the brain’s pain-control system. For investors, opiates matter because they carry both medical value and regulatory, legal, and public-health risks: approvals, prescribing trends, lawsuits, or tighter rules can sharply affect sales, patents, and a company’s reputation, much like a product that can heal but also trigger costly side effects or restrictions.

analyte medical

"whether a diagnostic system can distinguish the target analyte from other substances"

An analyte is a specific substance or chemical component measured in a laboratory test—such as a protein, molecule, ion, or biomarker—whose presence or amount gives information about a sample. For investors, analytes matter because tests and devices that detect or quantify them drive product demand, regulatory approval and recurring revenue; like a car’s fuel gauge showing fuel level, analyte measurements indicate health or disease status that affects market value.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Interference Study designed to validate system specificity in the presence of potentially interfering substances commonly encountered in real-world settings

Company expects to complete the study by mid-July 2026, with plans to include results in its FDA 510(k) submission package, along with data from the concurrent Method Comparison Study

NEW YORK, June 16, 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 initiation of an Interference Study to support its FDA 510(k) submission for U.S. market clearance of its Intelligent Fingerprinting Drug Screening System for detection of the opiate codeine.

The Company has again partnered with CenExel Clinical Research, Inc. to complete the clinical study. The Interference Study will assess how potentially interfering substances may impact the Intelligent Fingerprinting Drug Screening System’s accuracy and reliability. The study will enroll 75 healthy adult participants who will be evaluated under both undosed and dosed conditions while handling substances that could potentially interfere with test results. This rigorous protocol aims to show the system maintains codeine specificity, even when subjects have handled everyday substances before testing.

Interference testing is a critical FDA requirement that validates whether a diagnostic system can distinguish the target analyte from other substances encountered in daily life or workplace environments. The study evaluates whether handling common interferents affects the system's ability to accurately detect codeine, preventing false-positive or false-negative results that could have serious consequences for workplace drug screening programs.

The study’s protocol includes multiple collection time points, with results confirmed via liquid chromatography-tandem mass spectrometry (“LC-MS/MS”) analysis. This comprehensive approach ensures accurate system performance in varied real-world scenarios.

"Interference testing is critical to delivering a specific, reliable drug screening solution," said Harry Simeonidis, President and CEO at Intelligent Bio Solutions. "By rigorously testing how everyday substances might affect our system, we address a fundamental workplace drug screening concern by delivering results employers and employees can trust. This study is an important step toward FDA clearance and reinforces the robustness of our drug testing technology."

The Interference Study will run concurrently with the Company's Method Comparison Study and follows the clinical Cut-off Study that commenced in January 2026. Together, these three complementary studies form a comprehensive clinical package designed to meet FDA 510(k) requirements and demonstrate the safety, accuracy, usability, and specificity of the Intelligent Fingerprinting Drug Screening System.

The study will follow FDA guidance and ICH GCP (International Council for Harmonisation Good Clinical Practice) Guidelines. The Company expects to finish the study by mid-July 2026. Results will be included in its FDA 510(k) submission package, along with data from the Cut-off Study and Method Comparison Study.

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, secure regulatory clearance or approvals, and timelines to enter the U.S. Market, 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 study did Intelligent Bio Solutions (INBS) start on June 16, 2026?

Intelligent Bio Solutions began an Interference Study for its Intelligent Fingerprinting Drug Screening System targeting codeine detection. According to Intelligent Bio Solutions, the study assesses how everyday interfering substances impact system specificity and accuracy, supporting an FDA 510(k) submission for planned U.S. market clearance.

How many participants are in the INBS interference study for codeine drug screening?

The Interference Study will enroll 75 healthy adult participants. According to Intelligent Bio Solutions, participants will be evaluated under undosed and dosed conditions while handling common potentially interfering substances, with multiple collection time points and LC-MS/MS confirmation to assess impact on codeine detection accuracy.

When will Intelligent Bio Solutions (INBS) complete its interference study supporting FDA 510(k) clearance?

Intelligent Bio Solutions expects to complete the Interference Study by mid-July 2026. According to Intelligent Bio Solutions, results will be included in an FDA 510(k) submission package, alongside data from a Cut-off Study and a concurrent Method Comparison Study for its codeine screening system.

How does the INBS interference study support FDA 510(k) submission for the codeine fingerprinting test?

The Interference Study is designed to validate test specificity in real-world conditions for FDA 510(k) support. According to Intelligent Bio Solutions, it examines whether handling common interferents affects codeine detection, aiming to reduce false positives or negatives in workplace drug screening programs.

What role does CenExel Clinical Research play in the Intelligent Bio Solutions (INBS) study?

CenExel Clinical Research is partnering with Intelligent Bio Solutions to conduct the Interference Study. According to Intelligent Bio Solutions, CenExel will help run the 75-participant protocol under FDA guidance and ICH GCP standards, including multiple sampling points and LC-MS/MS confirmation for codeine detection.

How do the INBS Cut-off, Method Comparison, and Interference studies work together for FDA clearance?

The three INBS studies form a combined clinical package for the Intelligent Fingerprinting codeine test. According to Intelligent Bio Solutions, the Cut-off, Method Comparison, and Interference Studies together are intended to demonstrate safety, accuracy, usability, and specificity for FDA 510(k) requirements.