Intelligent Bio Solutions Completes Clinical Study Supporting FDA Submission
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Apr 02 2026
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Should l Buy INBS?
Intelligent Bio Solutions 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. 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 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. 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.
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Analyst Views on INBS
About INBS
Intelligent Bio Solutions Inc. is a medical technology company focused on delivering intelligent, rapid, non-invasive testing solutions. The Company’s active product is the Intelligent Fingerprinting Platform, which consists of a portable platform that analyzes fingerprint sweat using a one-time cartridge and portable handheld reader. Its Intelligent Fingerprinting Drug Screening System (the IFP System) is a two-part system that consists of non-invasive, fingerprint sweat-based diagnostic testing products designed to detect drugs of abuse, including opiates, cocaine, methamphetamines, benzodiazepines, cannabis, methadone, and buprenorphine. The IFP System comprises a single-use tamper-evident drug screening cartridge for sample collection and the Intelligent Fingerprinting DSR-Plus portable analysis unit onto which ten fingerprint sweat samples are collected in under a minute before the portable analysis unit provides an on-screen result in under ten minutes.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Intelligent Bio Solutions Launches Rapid Drug Testing Validation Study
- Significant Market Potential: The U.S. roadside drug testing market is projected to reach $1.62 billion by 2030, growing at a CAGR of 4.71%, providing INBS with substantial market opportunities amid rising drug-related accidents and fatalities.
- Analysis Time Reduction: The validation study aims to cut the analysis time of INBS's drug screening system from ten minutes to under three minutes, significantly enhancing law enforcement efficiency and improving road safety.
- Clear Technological Advantage: By providing rapid results, INBS's system not only meets the urgent needs of law enforcement for quick testing but also strengthens its market position as states expand drug testing programs following marijuana legalization.
- Diversified Market Expansion: Accelerated testing times will enable INBS to penetrate additional high-value sectors, such as drug treatment and consumer health markets, further enhancing its competitiveness in the global drug screening products market.
See More
Intelligent Bio Solutions Completes Penetration Testing for FDA Submission
- Successful Penetration Testing: Intelligent Bio Solutions Inc. has successfully completed penetration testing, identifying no major security vulnerabilities, which validates the robustness of its existing security infrastructure and strengthens its upcoming FDA 510(k) submission compliance.
- Security Upgrades Implemented: The company has implemented additional security upgrades in its drug testing technology, including enhanced encrypted identification tags and improved firmware safeguards, ensuring test integrity and protecting against cyber threats, thereby enhancing its commitment to data protection.
- Market Opportunity Expansion: By addressing security requirements early in the FDA 510(k) submission process, INBS positions its technology to meet evolving FDA guidance on medical device cybersecurity, and obtaining FDA clearance could open new revenue and expansion opportunities in the multi-billion-dollar U.S. drug screening market.
- Innovation Potential: INBS's Intelligent Fingerprinting Drug Screening System aims to revolutionize portable testing through fingerprint sweat analysis, providing results in under ten minutes, which is expected to become a valuable tool for employers in safety-critical industries, further driving the company's growth in global markets.
See More
Intelligent Bio Solutions Completes Initial Clinical Study for FDA Approval
- Clinical Study Completion: Intelligent Bio Solutions (INBS) announced the successful completion of its initial clinical study, which is essential for seeking FDA approval for its fingerprint-based drug testing system, yet this positive update did not prevent shares from plummeting nearly 20% in pre-market trading.
- Detection Capability Validation: The study evaluated the device's ability to detect codeine in 40 adults and confirmed its accuracy using standard laboratory testing methods, providing a scientific basis for future market applications despite the stock's poor performance.
- Project Advancement: INBS has commenced the second phase of its program, expected to be completed by June 2026, indicating the company's ongoing commitment to product development, even as market reactions remain unfavorable.
- Stock Price Volatility: Following a 7% decline in the previous trading session, INBS's stock fell sharply again after this announcement, reflecting investor concerns about the company's future prospects, which could impact its financing and market confidence.
See More
Intelligent Bio Solutions Advances FDA Submission for Drug Screening System
- Clinical Study Success: Intelligent Bio Solutions has completed a clinical Cut-off study involving 40 adults, validating the effectiveness of its Intelligent Fingerprinting Drug Screening System for codeine detection, providing robust data support for its FDA 510(k) submission and potentially accelerating its U.S. market entry.
- Multi-Site Study Initiation: The company has initiated the second phase of its clinical study program, which includes a multi-site Method Comparison and Usability Study aimed at validating the system's accuracy and user-friendliness, expected to be completed by the end of June 2026, thereby enhancing market confidence.
- Interference Study in Parallel: Alongside the Method Comparison study, the company will conduct an Interference Study to test the device against potentially interfering substances in real-world settings, anticipated to be completed by the end of July 2026, providing comprehensive assurance for market application.
- Significant Market Potential: The U.S. drug screening market represents a multi-billion-dollar annual opportunity, encompassing workplace testing, criminal justice, and substance abuse treatment, with the company's non-invasive fingerprint technology offering rapid and convenient advantages over traditional methods, likely leading to substantial commercial opportunities.
See More
Intelligent Bio Solutions Secures Eighth European Patent
- Patent Grant Progress: Intelligent Bio Solutions has secured its eighth European patent, EP3752831, which relates to contextualizing fingerprint chemical analysis with fingerprint deposition volume, further enhancing its intellectual property protection around fingerprint sweat drug testing technology.
- Innovation Enhancement: The new patent protects a key advancement in analyzing substances in fingerprint sweat by correlating chemical findings with the volume of fingerprint residue during sample collection, thereby improving the robustness and interpretative capacity of the testing process.
- Strengthened Market Position: CEO Harry Simeonidis noted that each patent reinforces the company's market position and protects scientific breakthroughs, making its non-invasive testing approach a compelling alternative to traditional drug screening methods.
- Expanded Application Areas: The company's Intelligent Fingerprinting Drug Testing Solution offers a faster, more dignified alternative for safety-critical sectors, enabling sample collection in seconds and results in under ten minutes, which is expected to positively impact industries such as construction, manufacturing, and transport.
See More
Intelligent Bio Solutions Shares Rise 11% on Manufacturing Partnership Announcement
- Stock Surge: Intelligent Bio Solutions Inc. (INBS) shares rose 11% in pre-market trading following the announcement of a new manufacturing partnership with Syrma Johari MedTech, reflecting strong market confidence in its new product rollout.
- Capacity Expansion: The company reported that its manufacturing capacity has increased to four times its previous level, which is expected to reduce annual production costs by over 40%, thereby enhancing gross margins by approximately 20 percentage points each year, significantly boosting profitability.
- Market Deployment: The newly launched Intelligent Fingerprinting Drug Screening Readers are being deployed across various sectors including construction, transportation, logistics, and manufacturing in the U.K. and Europe, indicating an increasing market penetration in these critical areas.
- Future Outlook: Intelligent Bio Solutions has also doubled its in-house production capacity for test strips and anticipates additional shipments in 2026 as it prepares for entry into the U.S. market, further expanding its market share.
See More
Intelligent Bio Solutions Launches Rapid Drug Testing Validation Study
- Significant Market Potential: The U.S. roadside drug testing market is projected to reach $1.62 billion by 2030, growing at a CAGR of 4.71%, providing INBS with substantial market opportunities amid rising drug-related accidents and fatalities.
- Analysis Time Reduction: The validation study aims to cut the analysis time of INBS's drug screening system from ten minutes to under three minutes, significantly enhancing law enforcement efficiency and improving road safety.
- Clear Technological Advantage: By providing rapid results, INBS's system not only meets the urgent needs of law enforcement for quick testing but also strengthens its market position as states expand drug testing programs following marijuana legalization.
- Diversified Market Expansion: Accelerated testing times will enable INBS to penetrate additional high-value sectors, such as drug treatment and consumer health markets, further enhancing its competitiveness in the global drug screening products market.
See More
Intelligent Bio Solutions Completes Penetration Testing for FDA Submission
- Successful Penetration Testing: Intelligent Bio Solutions Inc. has successfully completed penetration testing, identifying no major security vulnerabilities, which validates the robustness of its existing security infrastructure and strengthens its upcoming FDA 510(k) submission compliance.
- Security Upgrades Implemented: The company has implemented additional security upgrades in its drug testing technology, including enhanced encrypted identification tags and improved firmware safeguards, ensuring test integrity and protecting against cyber threats, thereby enhancing its commitment to data protection.
- Market Opportunity Expansion: By addressing security requirements early in the FDA 510(k) submission process, INBS positions its technology to meet evolving FDA guidance on medical device cybersecurity, and obtaining FDA clearance could open new revenue and expansion opportunities in the multi-billion-dollar U.S. drug screening market.
- Innovation Potential: INBS's Intelligent Fingerprinting Drug Screening System aims to revolutionize portable testing through fingerprint sweat analysis, providing results in under ten minutes, which is expected to become a valuable tool for employers in safety-critical industries, further driving the company's growth in global markets.
See More
Intelligent Bio Solutions Completes Initial Clinical Study for FDA Approval
- Clinical Study Completion: Intelligent Bio Solutions (INBS) announced the successful completion of its initial clinical study, which is essential for seeking FDA approval for its fingerprint-based drug testing system, yet this positive update did not prevent shares from plummeting nearly 20% in pre-market trading.
- Detection Capability Validation: The study evaluated the device's ability to detect codeine in 40 adults and confirmed its accuracy using standard laboratory testing methods, providing a scientific basis for future market applications despite the stock's poor performance.
- Project Advancement: INBS has commenced the second phase of its program, expected to be completed by June 2026, indicating the company's ongoing commitment to product development, even as market reactions remain unfavorable.
- Stock Price Volatility: Following a 7% decline in the previous trading session, INBS's stock fell sharply again after this announcement, reflecting investor concerns about the company's future prospects, which could impact its financing and market confidence.
See More
Intelligent Bio Solutions Advances FDA Submission for Drug Screening System
- Clinical Study Success: Intelligent Bio Solutions has completed a clinical Cut-off study involving 40 adults, validating the effectiveness of its Intelligent Fingerprinting Drug Screening System for codeine detection, providing robust data support for its FDA 510(k) submission and potentially accelerating its U.S. market entry.
- Multi-Site Study Initiation: The company has initiated the second phase of its clinical study program, which includes a multi-site Method Comparison and Usability Study aimed at validating the system's accuracy and user-friendliness, expected to be completed by the end of June 2026, thereby enhancing market confidence.
- Interference Study in Parallel: Alongside the Method Comparison study, the company will conduct an Interference Study to test the device against potentially interfering substances in real-world settings, anticipated to be completed by the end of July 2026, providing comprehensive assurance for market application.
- Significant Market Potential: The U.S. drug screening market represents a multi-billion-dollar annual opportunity, encompassing workplace testing, criminal justice, and substance abuse treatment, with the company's non-invasive fingerprint technology offering rapid and convenient advantages over traditional methods, likely leading to substantial commercial opportunities.
See More
Intelligent Bio Solutions Secures Eighth European Patent
- Patent Grant Progress: Intelligent Bio Solutions has secured its eighth European patent, EP3752831, which relates to contextualizing fingerprint chemical analysis with fingerprint deposition volume, further enhancing its intellectual property protection around fingerprint sweat drug testing technology.
- Innovation Enhancement: The new patent protects a key advancement in analyzing substances in fingerprint sweat by correlating chemical findings with the volume of fingerprint residue during sample collection, thereby improving the robustness and interpretative capacity of the testing process.
- Strengthened Market Position: CEO Harry Simeonidis noted that each patent reinforces the company's market position and protects scientific breakthroughs, making its non-invasive testing approach a compelling alternative to traditional drug screening methods.
- Expanded Application Areas: The company's Intelligent Fingerprinting Drug Testing Solution offers a faster, more dignified alternative for safety-critical sectors, enabling sample collection in seconds and results in under ten minutes, which is expected to positively impact industries such as construction, manufacturing, and transport.
See More
Intelligent Bio Solutions Shares Rise 11% on Manufacturing Partnership Announcement
- Stock Surge: Intelligent Bio Solutions Inc. (INBS) shares rose 11% in pre-market trading following the announcement of a new manufacturing partnership with Syrma Johari MedTech, reflecting strong market confidence in its new product rollout.
- Capacity Expansion: The company reported that its manufacturing capacity has increased to four times its previous level, which is expected to reduce annual production costs by over 40%, thereby enhancing gross margins by approximately 20 percentage points each year, significantly boosting profitability.
- Market Deployment: The newly launched Intelligent Fingerprinting Drug Screening Readers are being deployed across various sectors including construction, transportation, logistics, and manufacturing in the U.K. and Europe, indicating an increasing market penetration in these critical areas.
- Future Outlook: Intelligent Bio Solutions has also doubled its in-house production capacity for test strips and anticipates additional shipments in 2026 as it prepares for entry into the U.S. market, further expanding its market share.
See More
