Interference study backs Intelligent Bio (NASDAQ: INBS) U.S. codeine test

Filing Impact

(Moderate)

Filing Sentiment

(Neutral)

Form Type

8-K

Rhea-AI Filing Summary

Intelligent Bio Solutions Inc. filed a current report describing a new Interference Study to support its FDA 510(k) submission for U.S. clearance of its Intelligent Fingerprinting Drug Screening System for detecting the opiate codeine. The company has partnered with CenExel Clinical Research to run the study with 75 healthy adult participants under undosed and dosed conditions while handling common substances that might affect results.

The study is designed to show the system maintains specificity for codeine and avoids false positives or negatives, with samples confirmed by LC‑MS/MS analysis. It will run alongside a Method Comparison Study and follows a Cut-off Study that began in January 2026. Intelligent Bio Solutions expects to finish the Interference Study by mid‑July 2026 and include the data in its FDA 510(k) submission package.

8-K Event Classification

2 items: 7.01, 9.01

2 items

Item 7.01 Regulation FD Disclosure Disclosure

Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.

Item 9.01 Financial Statements and Exhibits Exhibits

Financial statements, pro forma financial information, and exhibit attachments filed with this report.

Key Figures

Interference Study enrollment: 75 participants Planned study completion: mid-July 2026 Fingerprint test turnaround: under ten minutes

3 metrics

Interference Study enrollment 75 participants Healthy adult participants in codeine Interference Study

Planned study completion mid-July 2026 Expected completion date for Interference Study

Fingerprint test turnaround under ten minutes Time to obtain results from drug screening system

Key Terms

FDA 510(k), Interference Study, LC-MS/MS, ICH GCP, +1 more

5 terms

FDA 510(k) regulatory

"to support its 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.

Interference Study technical

"announced the initiation of an Interference Study to support its FDA 510(k)"

An interference study tests whether other substances or conditions prevent a medical test, drug measurement, or diagnostic device from working properly, like checking if a smartphone case blocks charging. Investors should care because interference problems can limit a product’s accuracy, regulatory approval, market acceptance, or lead to costly redesigns and lost sales, so clear results reduce risk and support commercial reliability.

LC-MS/MS technical

"results confirmed via 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.

ICH GCP regulatory

"The study will follow FDA guidance and ICH GCP Guidelines"

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.

Method Comparison Study technical

"will run concurrently with the Company’s Method Comparison Study"

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Understanding 8-K Material Events →

06/16/2026 - 04:30 PM

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of

the Securities Exchange Act of 1934

Date of Report (Date of Earliest Event Reported): June 16, 2026

INTELLIGENT BIO SOLUTIONS INC.

(Exact name of registrant as specified in its charter)

Delaware

001-39825

82-1512711

(State of

Incorporation)

(Commission

File Number)

(IRS employer

identification no.)

135 West, 41st Street, 5th Floor

New York, NY 10036

(Address of principal executive offices, including zip code)

Registrant’s telephone number, including area code: (646) 790-5756

N/A

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common Stock, $0.01 par value		INBS		The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2). Emerging growth company ☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 7.01 Regulation FD Disclosure.

On June 16, 2026, Intelligent Bio Solutions Inc. (the “Company”), issued a press release (the “Press Release”) announcing 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. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K. The foregoing disclosure is qualified in its entirety by the full text of the Press Release.

The information contained in Item 7.01 of this Current Report on Form 8-K, including Exhibit 99.1, is being furnished and shall not be deemed to be “filed” for the purpose of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), nor shall it be deemed incorporated by reference in any filing under the Exchange Act or the Securities Act of 1933, as amended, unless specifically identified therein as being incorporated by reference.

Item 9.01 Financial Statements and Exhibits.

No.		Description
99.1		Press release dated June 16, 2026
104		Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Date: June 16, 2026

	INTELLIGENT BIO SOLUTIONS INC.

	By:	/s/ Spiro Sakiris
	Name:	Spiro Sakiris
	Title:	Chief Financial Officer

Exhibit 99.1

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

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 – 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

Source: View Original Filing on SEC EDGAR

FAQ

What did Intelligent Bio Solutions (INBS) announce in this 8-K filing?

Intelligent Bio Solutions announced it has started an Interference Study to support its FDA 510(k) submission for U.S. clearance of its Intelligent Fingerprinting Drug Screening System targeting codeine detection, adding to its broader clinical evidence package.

How many participants are in Intelligent Bio Solutions’ Interference Study for codeine?

The Interference Study will enroll 75 healthy adult participants. They will be evaluated under both undosed and dosed conditions while handling everyday substances, helping assess whether these interferents affect the system’s codeine detection accuracy and reliability in real-world scenarios.

When does Intelligent Bio Solutions expect to complete the Interference Study?

The company expects to complete the Interference Study by mid-July 2026. Results are planned for inclusion in its FDA 510(k) submission package, alongside data from the concurrent Method Comparison Study and the earlier Cut-off Study that began in January 2026.

What is the purpose of the Interference Study for Intelligent Bio Solutions’ drug screening system?

The Interference Study is designed to show the system’s specificity for codeine in the presence of potentially interfering substances. It aims to confirm that handling everyday materials does not cause false-positive or false-negative results, a key FDA requirement for workplace drug screening reliability.

Which technologies and standards are used in Intelligent Bio Solutions’ new study?

The study confirms results using LC-MS/MS, a highly sensitive analytical method. It follows FDA guidance and ICH GCP (International Council for Harmonisation Good Clinical Practice) Guidelines, forming part of a comprehensive clinical package supporting the Intelligent Fingerprinting Drug Screening System.

What drugs can Intelligent Bio Solutions’ fingerprinting system screen for?

The Intelligent Fingerprinting Drug Screening System screens for recent use of drugs commonly found in workplaces, including opiates, cocaine, methamphetamine, and cannabis. It uses fingerprint sweat analysis to provide rapid, non-invasive results, with sample collection in seconds and results in under ten minutes.

Filing Exhibits & Attachments

4 documents

Press Releases

EX-99.1 EX-99.1 14.8 KB