Intelligent Bio Solutions Completes Clinical Cut-off Study, Advances FDA 510(k) Clinical Program Targeting Multi-Billion-Dollar U.S. Drug Screening Market
MWN-AI** Summary
Intelligent Bio Solutions Inc. (Nasdaq: INBS) has announced the successful completion of its initial clinical Cut-off Study, which demonstrates its Intelligent Fingerprinting Drug Screening System’s capability to detect codeine. This milestone supports the company's FDA 510(k) submission for market clearance in the U.S. The study involved 40 adults and confirmed the research findings through comparisons with an FDA-cleared device and liquid chromatography-tandem mass spectrometry (LC-MS/MS).
Following this achievement, INBS is advancing into the second phase of its clinical program. This new phase includes a multi-site Method Comparison and Usability Study, aimed at validating the fingerprinting system’s accuracy and performance in real-world environments. The company expects to complete this study by the end of June 2026, alongside an Interference Study, assessing how accurately the device functions amid various potentially interfering substances. Results from this study are anticipated by the end of July 2026.
Harry Simeonidis, President and CEO of INBS, emphasized the significance of the U.S. drug screening market, highlighting its multi-billion-dollar potential in sectors such as workplace testing, criminal justice, pain management, and substance abuse treatment. The Intelligent Fingerprinting Drug Screening System offers notable advantages over traditional testing methods, including rapid, non-invasive results that can identify current impairment.
The system's efficiency allows for swift sample collection and result delivery, promising to be a valuable resource for employers in safety-sensitive industries. As INBS moves forward, its innovative technology could drastically transform portable testing standards through fingerprint sweat analysis, paving the way for broader applications in the future.
For additional information, please visit their website at https://ibs.inc/.
MWN-AI** Analysis
Intelligent Bio Solutions Inc. (Nasdaq: INBS) has recently achieved a significant milestone by successfully completing its clinical cut-off study for the Intelligent Fingerprinting Drug Screening System, which targets the lucrative U.S. drug screening market. This development, alongside ongoing efforts to finalize FDA 510(k) submissions, positions INBS favorably for anticipated market entry.
As the company continues its second phase of clinical trials focused on method comparison, usability, and interference testing, investors should note the potential implications of these advancements. The completion of the cut-off study not only validates INBS's clinical methodology but also strengthens its credibility with regulatory bodies, paving the way for FDA clearance. This is crucial, as the U.S. drug screening market is a multi-billion-dollar sector with diverse applications, including workplace safety, criminal justice, and pain management.
The distinct advantages of the Intelligent Fingerprinting Drug Screening System—such as non-invasive testing through fingerprint analysis, rapid results, and a focused detection window for current impairment—give INBS a competitive edge over traditional testing methods. As industries increasingly prioritize immediate and accurate testing solutions, INBS appears well-positioned to capture a share of this growing market.
However, potential investors should remain cautious. Despite the promising results and market potential, all forward-looking statements carry inherent risks. The company's success heavily relies on regulatory outcomes, rapid adoption in the marketplace, and effective execution of its clinical programs.
In conclusion, while Intelligent Bio Solutions shows significant promise with its innovative drug screening technology and favorable clinical advancements, investors should adopt a prudent approach, weighing the potential for growth against the uncertainties traditional in health tech investments. Monitoring the company's upcoming clinical trial results and FDA progress will be key to making informed decisions.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
Study results finalized on schedule support FDA clearance and planned U.S. commercial launch
Company advances second phase of clinical program for 510(k) submission with method comparison, usability, and interference testing
NEW YORK, April 02, 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 successful completion of its initial clinical Cut-off Study supporting the Company's FDA 510(k) submission for U.S. market clearance of its Intelligent Fingerprinting Drug Screening System for detection of the opiate codeine.
The clinical Cut-off Study evaluated codeine detection cut-off levels in 40 adults, with full data analysis completed as planned by the end of March 2026. The study used the Intelligent Fingerprinting Drug Screening Cartridge with the DSR-Plus fluorescence reader, compared results with an FDA-cleared predicate device, and confirmed findings through liquid chromatography-tandem mass spectrometry (“LC-MS/MS”) analysis.
INBS has now initiated the second phase of its clinical study program. This includes a multi-site Method Comparison and Usability Study. This study is designed to validate the system’s accuracy, usability, and workplace performance when operated by intended end users at several clinical sites. The Company expects to complete the Method Comparison and Usability Study by the end of June 2026. In parallel with the Method Comparison and Usability Study, the Company will be commencing an Interference Study, which will test the device in the presence of potentially interfering substances found in real-world settings. Completion of the Interference Study is anticipated by the end of July 2026.
"The U.S. drug screening market is a significant commercial opportunity for Intelligent Bio Solutions," said Harry Simeonidis, President and CEO at INBS, "The on-schedule completion of our Cut-off Study validates our clinical approach and keeps us firmly on track toward our FDA 510(k) submission and planned commercial launch."
The U.S. drug screening market represents a multi-billion-dollar annual opportunity. Major segments include workplace testing, criminal justice, pain management, and substance abuse treatment. The Company’s non-invasive fingerprint technology offers several advantages over traditional urine, oral fluid, and blood testing methods. Benefits include a detection window designed to identify current impairment rather than past use, rapid results, and the ability to conduct screening at any time and location.
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**
What specific outcomes from the initial clinical Cut-off Study conducted by Intelligent Bio Solutions Inc. (INBS) have contributed to the FDA 510(k) submission for the Intelligent Fingerprinting Drug Screening System?
How does Intelligent Bio Solutions Inc. (INBS) plan to leverage the findings from the upcoming Method Comparison and Usability Study to ensure successful U.S. market clearance and commercial launch of its drug screening technology?
What potential challenges does Intelligent Bio Solutions Inc. (INBS) foresee in conducting the Interference Study, and how might these challenges affect their timeline for FDA approval?
In which key sectors does Intelligent Bio Solutions Inc. (INBS) see the greatest market opportunity for its non-invasive drug screening technology, especially within the multi-billion-dollar U.S. drug screening market?
**MWN-AI FAQ is based on asking OpenAI questions about Intelligent Bio Solutions Inc. (NASDAQ: INBS).
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