Intelligent Bio Solutions Achieves Above 98% Accuracy in Method Comparison Study, Supporting Planned 2026 FDA 510(k) Submission

Rhea-AI Summary

Intelligent Bio Solutions (Nasdaq: INBS) reported results from a multi-site U.S. Method Comparison Study of its Intelligent Fingerprinting Drug Screening System for detecting the opiate codeine. Conducted at three independent clinical sites in pre-employment and workplace settings, the study assessed sensitivity, specificity and accuracy against an LC-MS/MS reference method.

The System achieved total accuracy of 98.2%, sensitivity of 94.6%, and specificity of 100% across 214 samples (144 true negatives, 70 true positives, 4 false negatives, 0 false positives). Accuracy and sensitivity improved versus a prior 2024 study, which showed approximately 94% accuracy and 82% sensitivity, while specificity remained at 100%. The data complete the company’s FDA 510(k) clinical package, and Intelligent Bio Solutions now expects to submit its 510(k) application for the System in September 2026, supporting a planned U.S. market entry following potential FDA clearance.

Positive

• Accuracy 98.2%, sensitivity 94.6%, specificity 100% for codeine across three sites
• Improved vs prior study: accuracy up from ~94%, sensitivity from ~82% to above 94%
• Zero false positives reported; 144 true negatives and 70 true positives vs 4 false negatives
• All 510(k) clinical data complete, enabling targeted 510(k) submission in September 2026

Negative

• None.

Market Reaction – INBS

+1.21% $2.43 2280.4x vol

15m delay

+1.21% Vs previous close

+28.7% Peak Tracked

-10.6% Trough Tracked

$2.43 Last Price

$2.42 $3.27 Day Range

$7.35M Market Cap

2280.4x Rel. Volume

Following this news, INBS has gained 1.21%, reflecting a mild positive market reaction. Argus tracked a peak move of +28.7% during the session. Argus tracked a trough of -10.6% from its starting point during tracking. Our momentum scanner has triggered 32 alerts so far, indicating elevated trading interest and price volatility. The stock is currently trading at $2.43. Trading volume is exceptionally heavy at 2280.4x the average, suggesting very strong buying interest.

Data tracked by StockTitan Argus (15 min delayed). Upgrade to Gold for real-time data.

Market Context

The stock is surging +12.1% following this news. A prior ISO recertification announcement coincided ...

Analysis

The stock is surging +12.1% following this news. A prior ISO recertification announcement coincided with a 21.66% 24-hour gain, providing a platform precedent for positive regulatory-readiness news. The active S-3 is a resale registration, and the company receives no resale proceeds.

Key Figures

Total Accuracy: 98.2% Total Sensitivity: 94.6% Specificity: 100% +5 more

8 metrics

Total Accuracy 98.2% Method Comparison Study across three sites

Total Sensitivity 94.6% Opiate codeine detection

Specificity 100% Opiate codeine detection

Prior Accuracy approximately 94% Company's November 2024 study

Prior Sensitivity 82% Company's November 2024 study

Clinical Sites three Independent U.S. clinical sites

Planned Submission September 2026 FDA 510(k) application

False Positives 0 Total study results

Historical Context

5 past events · Latest: Aug 19 (Positive)

Pattern 5 events

Date	Event	Sentiment	24h Move	Catalyst
Aug 19	Fiscal earnings report	Positive	-15.7%	Revenue growth and margin expansion accompanied by a wider net loss.
Aug 17	ISO recertification	Positive	+21.7%	ISO 13485:2016 recertification supported the ongoing FDA clearance application.
Aug 11	Clinical study completion	Positive	+4.6%	Multi-site method comparison study completed for the FDA 510(k) program.
Aug 05	Usability study completion	Positive	-1.1%	Non-specialist operators completed usability testing supporting FDA submission preparation.
Aug 03	Interference study completion	Positive	+0.6%	Interference testing addressed everyday substances affecting system accuracy.

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

Pattern Detected

Recent positive operational and regulatory announcements produced mostly positive reactions, while the earnings release and usability update diverged negatively.

Key Terms

510(k), lc-ms/ms, specificity

3 terms

510(k) regulatory

"supporting its planned 2026 FDA 510(k) Submission"

A 510(k) is a U.S. regulatory submission that a medical device maker uses to show a new device is as safe and effective as an already-approved device, allowing the regulator to clear it for sale rather than requiring the longer, more stringent approval process. For investors, a cleared 510(k) usually means lower regulatory risk and a faster path to market, which can speed revenue generation and reduce uncertainty—similar to proving a new appliance works like a trusted existing model.

lc-ms/ms technical

"a validated liquid chromatography-tandem mass spectrometry"

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.

specificity medical

"evaluated the sensitivity, specificity, and accuracy"

Specificity measures how well a diagnostic test or screening correctly identifies people who do not have a condition — the percentage of healthy cases the test labels as negative. Think of it as a smoke alarm that stays quiet when there’s no fire; high specificity means fewer false alarms. For investors, specificity affects regulatory approval, clinical adoption, follow-up costs, and the perceived reliability and market potential of medical products.

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

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Multi-site clinical study delivers strong performance data for Intelligent Fingerprinting Drug Screening System

NEW YORK, Sept. 01, 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 results of its latest Method Comparison Study for its Intelligent Fingerprinting Drug Screening System (the “System”) to detect the opiate codeine. Conducted across three independent U.S. clinical sites, the study represents the most comprehensive evaluation of the System in the Company's FDA 510(k) clinical study program. The study results show substantially improved performance compared to the Company's prior Method Comparison Study, announced in November of 2024.

The purpose of the study was to evaluate the System's consistency and reliability across diverse clinical environments. The study followed established clinical research guidelines and evaluated the sensitivity, specificity, and accuracy of the Intelligent Fingerprinting Drug Screening System in pre-employment and workplace screening environments.

Method Comparison Study Results

Parameter	Site 1	Site 2	Site 3	Total
True Negative	48	45	51	144
False Negative	1	2	1	4
True Positive	27	27	16	70
False Positive	0	0	0	0
Sensitivity	96.4%	93.1%	94.1%	94.6%
Specificity	100%	100%	100%	100%
Accuracy	98.7%	97.3%	98.5%	98.2%

The System demonstrated accuracy above 98%, sensitivity above 94%, and specificity of 100% for the opiate codeine. These figures represent a notable increase from the Company's previous study, which reported approximately 94% accuracy and 82% sensitivity. The System's 100% specificity, unchanged from the prior study, continues to confirm its ability to correctly identify samples that do not contain the target drug, a critical requirement for workplace drug testing applications where false positives can carry significant consequences. Results were measured against a validated liquid chromatography-tandem mass spectrometry (“LC-MS/MS”) reference method.

"These results have been a long time in the making," said Harry Simeonidis, President and CEO of Intelligent Bio Solutions. "Our System was already delivering 100% specificity, but we knew we needed to close the gap on sensitivity. Moving from approximately 82% sensitivity to above 94%, and in doing so lifting our overall accuracy to above 98%, is the outcome we were working toward. With this study complete, we now have everything we need for our 510(k) submission, which remains on track for submittal in calendar 2026."

The results form a critical component of the Company's 510(k) submission package. With all data collection now complete, the Company has accelerated its filing timeline and expects to submit its 510(k) application in September 2026, supporting its planned entry into the U.S. market following FDA clearance.

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

What accuracy did Intelligent Bio Solutions’ INBS fingerprinting drug screening system achieve in the 2026 study?

The System achieved 98.2% overall accuracy for detecting codeine. According to Intelligent Bio Solutions, this was based on results from three independent U.S. clinical sites, totaling 214 samples, and reflects an improvement over its previous Method Comparison Study reported in November 2024.

How did sensitivity and specificity for INBS’s drug screening system change compared with the 2024 study?

Sensitivity increased to 94.6% while specificity remained at 100%. According to Intelligent Bio Solutions, this represents a rise in sensitivity from approximately 82% and an improvement in accuracy from around 94%, with specificity consistently confirming correct identification of samples without the target drug.

When does Intelligent Bio Solutions (NASDAQ: INBS) plan to submit its FDA 510(k) application?

Intelligent Bio Solutions expects to submit its 510(k) application in September 2026. According to the company, all clinical data collection for the Intelligent Fingerprinting Drug Screening System is now complete, allowing an accelerated filing timeline as part of its broader U.S. market entry plans.

How many clinical sites and samples were included in Intelligent Bio Solutions’ 2026 Method Comparison Study?

The study included three independent U.S. clinical sites and 214 total samples. According to Intelligent Bio Solutions, the dataset comprised 144 true negatives, 70 true positives, four false negatives and no false positives, forming a key component of its FDA 510(k) submission package.

What do zero false positives mean for INBS’s Intelligent Fingerprinting Drug Screening System?

Zero false positives indicate the System showed 100% specificity in this study. According to Intelligent Bio Solutions, this supports its ability to correctly identify samples without codeine, an important factor for workplace drug testing where incorrect positive results can have serious consequences.

Which drug did Intelligent Bio Solutions’ 2026 Method Comparison Study focus on for the INBS system?

The study focused on detecting the opiate codeine using the System. According to Intelligent Bio Solutions, performance for codeine was measured against a validated LC-MS/MS reference method in pre-employment and workplace screening environments across three independent clinical sites in the United States.