Intelligent Bio Solutions Initiates Multi-Site Study for FDA Submission
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jun 02 2026
0mins
Intelligent Bio Solutions announced the initiation of a multi-site method comparison study to support its FDA 510 submission for U.S. market clearance of its Intelligent Fingerprinting Drug Screening System for the opiate codeine. The company has partnered with nationwide clinical research site network, CenExel Clinical Research, Inc., to perform the study, which will evaluate the accuracy of the Intelligent Fingerprinting Drug Screening System when operated by intended end-users across multiple clinical sites. A total of 135 donor participants will be enrolled and randomized into dosing groups, with demographics designed to reflect the diversity of the U.S. population. Fingerprint sweat specimens will be collected and analyzed by nine operator participants representing typical workplace drug screening personnel.
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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 Initiates Clinical Study for Drug Screening System
- Clinical Study Launch: Intelligent Bio Solutions Inc. has announced the initiation of a clinical study to support its 510(k) application for the Fingerprint Drug Screening system, with completion expected by mid-July 2026, aimed at enhancing the accuracy and efficiency of drug screening.
- Rapid Screening Mechanism: The system utilizes a hygienic fingerprint sweat screening mechanism that can deliver results for opiate drugs like codeine within 10 minutes, addressing workplace needs for quick drug testing and improving corporate safety management capabilities.
- Collaborative Research: The company has partnered with CenExel Clinical Research Inc. to conduct clinical and interference studies to validate the test's precision in identifying codeine residues, ensuring compliance with FDA's stringent interference testing requirements to reduce false positives.
- Data Submission Preparation: Results from the study will be included in the FDA 510(k) submission package, along with data from the cut-off study and method comparison study, further enhancing the product's market competitiveness and regulatory compliance.
See More
Intelligent Bio Solutions Initiates Interference Study for Drug Screening System
- Study Launch: Intelligent Bio Solutions Inc. has announced the initiation of an Interference Study aimed at validating the specificity of its Intelligent Fingerprinting Drug Screening System against common interfering substances in real-world settings, with completion expected by mid-July 2026.
- Clinical Collaboration: The study will be conducted in partnership with CenExel Clinical Research, enrolling 75 healthy adult participants to assess the accuracy of the test after exposure to potential interferents, thereby ensuring the system's reliability in practical applications.
- FDA Requirement: Interference testing is a critical FDA requirement that validates whether a diagnostic system can accurately distinguish the target analyte from other substances encountered in daily life, preventing false-positive or false-negative results that could significantly impact workplace drug screening programs.
- Comprehensive Clinical Package: This study runs concurrently with the Method Comparison Study and the clinical Cut-off Study, forming 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.
See More
Intelligent Bio Solutions to Participate in Planet MicroCap Conference
- Conference Participation: Intelligent Bio Solutions Inc. will participate in the Planet MicroCap Conference from June 16-18, 2026, at the Bellagio Hotel in Las Vegas, showcasing its innovative non-invasive testing solutions, which is expected to attract potential investor interest.
- Presentation Schedule: The management team is set to present on June 17 from 8:00 to 8:30 AM, aiming to highlight the advantages of its Intelligent Fingerprinting Drug Screening System, thereby enhancing market awareness and attracting investments.
- One-on-One Meetings: Throughout the event, INBS will arrange one-on-one meetings with investors, providing opportunities for in-depth business discussions, which aim to strengthen relationships with potential investors and drive future funding opportunities.
- Technological Advantage: The Intelligent Fingerprinting Drug Screening System enables rapid and hygienic drug testing through fingerprint sweat analysis, delivering results in under ten minutes, which is expected to provide a crucial tool for employers in safety-critical industries, enhancing industry safety standards.
See More
Initiation of Intelligent Fingerprinting Drug Screening System Study
- Study Launch: Intelligent Bio Solutions Inc. has announced the initiation of a multi-site Method Comparison Study to support its FDA 510(k) submission, expecting to complete participant enrollment and data collection by the end of July 2026, aimed at validating the accuracy of the Intelligent Fingerprinting Drug Screening System.
- Participant Recruitment: The study will enroll 135 donor participants randomized into dosing groups, with demographics designed to reflect the diversity of the U.S. population, ensuring the broad applicability and effectiveness of the study results.
- User Performance Evaluation: The study will assess key performance metrics including the system's sensitivity, specificity, and overall accuracy, with results independently confirmed via liquid chromatography-tandem mass spectrometry (LC-MS/MS), ensuring the reliability and validity of the data.
- Market Competitive Advantage: The CEO stated that demonstrating typical workplace personnel can accurately operate the system will validate a core competitive advantage, enhancing its market position in workplace drug screening, particularly in the potential for U.S. market expansion.
See More
Intelligent Bio Solutions Reports Q3 Financial Results
- Financial Highlights: Intelligent Bio Solutions reported a Q3 GAAP EPS of -$1.80, indicating a loss; however, the company showed resilience with improvements in revenue and gross margin.
- Revenue Growth: The Q3 revenue reached $1.06 million with a gross profit margin of 50.5%, up from 46.8% in the same period last year, reflecting positive progress in cost management and sales strategies.
- Sales Performance: For the nine months ended March 31, 2026, cartridge sales totaled $1.86 million, a 46% year-over-year increase, representing 61% of total revenue, indicating strong product demand.
- Cash Position: As of March 31, 2026, the company had cash and cash equivalents of $6.86 million, significantly up from $740,371 at December 31, 2025, enhancing financial stability and future investment capacity.
See More
Intelligent Bio Solutions Reports Strong Q3 Revenue Growth and Margin Expansion
- Significant Revenue Growth: Q3 cartridge revenue surged 59% year-over-year to $703,538, representing 66% of total quarterly sales, indicating strong performance under the recurring revenue model and expected to drive future market expansion.
- Robust Nine-Month Performance: Total revenue for the nine months ended March 31, 2026, reached $3.07 million, up 39% year-over-year, building on a $2.01 million first-half milestone, demonstrating sustained commercial momentum.
- Margin Expansion: The gross margin for Q3 hit 50.5%, up approximately 800 basis points from 46.8% in the prior year, reflecting successful operational efficiencies and increased sales volumes, enhancing unit economics.
- Market Investment Returns: The company's $1.77 million marketing investment over the past nine months directly contributed to 39% revenue growth, while Q3 marketing spend decreased by 42% year-over-year, indicating improved brand awareness and market presence.
See More
Intelligent Bio Solutions Initiates Clinical Study for Drug Screening System
- Clinical Study Launch: Intelligent Bio Solutions Inc. has announced the initiation of a clinical study to support its 510(k) application for the Fingerprint Drug Screening system, with completion expected by mid-July 2026, aimed at enhancing the accuracy and efficiency of drug screening.
- Rapid Screening Mechanism: The system utilizes a hygienic fingerprint sweat screening mechanism that can deliver results for opiate drugs like codeine within 10 minutes, addressing workplace needs for quick drug testing and improving corporate safety management capabilities.
- Collaborative Research: The company has partnered with CenExel Clinical Research Inc. to conduct clinical and interference studies to validate the test's precision in identifying codeine residues, ensuring compliance with FDA's stringent interference testing requirements to reduce false positives.
- Data Submission Preparation: Results from the study will be included in the FDA 510(k) submission package, along with data from the cut-off study and method comparison study, further enhancing the product's market competitiveness and regulatory compliance.
See More
Intelligent Bio Solutions Initiates Interference Study for Drug Screening System
- Study Launch: Intelligent Bio Solutions Inc. has announced the initiation of an Interference Study aimed at validating the specificity of its Intelligent Fingerprinting Drug Screening System against common interfering substances in real-world settings, with completion expected by mid-July 2026.
- Clinical Collaboration: The study will be conducted in partnership with CenExel Clinical Research, enrolling 75 healthy adult participants to assess the accuracy of the test after exposure to potential interferents, thereby ensuring the system's reliability in practical applications.
- FDA Requirement: Interference testing is a critical FDA requirement that validates whether a diagnostic system can accurately distinguish the target analyte from other substances encountered in daily life, preventing false-positive or false-negative results that could significantly impact workplace drug screening programs.
- Comprehensive Clinical Package: This study runs concurrently with the Method Comparison Study and the clinical Cut-off Study, forming 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.
See More
Intelligent Bio Solutions to Participate in Planet MicroCap Conference
- Conference Participation: Intelligent Bio Solutions Inc. will participate in the Planet MicroCap Conference from June 16-18, 2026, at the Bellagio Hotel in Las Vegas, showcasing its innovative non-invasive testing solutions, which is expected to attract potential investor interest.
- Presentation Schedule: The management team is set to present on June 17 from 8:00 to 8:30 AM, aiming to highlight the advantages of its Intelligent Fingerprinting Drug Screening System, thereby enhancing market awareness and attracting investments.
- One-on-One Meetings: Throughout the event, INBS will arrange one-on-one meetings with investors, providing opportunities for in-depth business discussions, which aim to strengthen relationships with potential investors and drive future funding opportunities.
- Technological Advantage: The Intelligent Fingerprinting Drug Screening System enables rapid and hygienic drug testing through fingerprint sweat analysis, delivering results in under ten minutes, which is expected to provide a crucial tool for employers in safety-critical industries, enhancing industry safety standards.
See More
Initiation of Intelligent Fingerprinting Drug Screening System Study
- Study Launch: Intelligent Bio Solutions Inc. has announced the initiation of a multi-site Method Comparison Study to support its FDA 510(k) submission, expecting to complete participant enrollment and data collection by the end of July 2026, aimed at validating the accuracy of the Intelligent Fingerprinting Drug Screening System.
- Participant Recruitment: The study will enroll 135 donor participants randomized into dosing groups, with demographics designed to reflect the diversity of the U.S. population, ensuring the broad applicability and effectiveness of the study results.
- User Performance Evaluation: The study will assess key performance metrics including the system's sensitivity, specificity, and overall accuracy, with results independently confirmed via liquid chromatography-tandem mass spectrometry (LC-MS/MS), ensuring the reliability and validity of the data.
- Market Competitive Advantage: The CEO stated that demonstrating typical workplace personnel can accurately operate the system will validate a core competitive advantage, enhancing its market position in workplace drug screening, particularly in the potential for U.S. market expansion.
See More
Intelligent Bio Solutions Reports Q3 Financial Results
- Financial Highlights: Intelligent Bio Solutions reported a Q3 GAAP EPS of -$1.80, indicating a loss; however, the company showed resilience with improvements in revenue and gross margin.
- Revenue Growth: The Q3 revenue reached $1.06 million with a gross profit margin of 50.5%, up from 46.8% in the same period last year, reflecting positive progress in cost management and sales strategies.
- Sales Performance: For the nine months ended March 31, 2026, cartridge sales totaled $1.86 million, a 46% year-over-year increase, representing 61% of total revenue, indicating strong product demand.
- Cash Position: As of March 31, 2026, the company had cash and cash equivalents of $6.86 million, significantly up from $740,371 at December 31, 2025, enhancing financial stability and future investment capacity.
See More
Intelligent Bio Solutions Reports Strong Q3 Revenue Growth and Margin Expansion
- Significant Revenue Growth: Q3 cartridge revenue surged 59% year-over-year to $703,538, representing 66% of total quarterly sales, indicating strong performance under the recurring revenue model and expected to drive future market expansion.
- Robust Nine-Month Performance: Total revenue for the nine months ended March 31, 2026, reached $3.07 million, up 39% year-over-year, building on a $2.01 million first-half milestone, demonstrating sustained commercial momentum.
- Margin Expansion: The gross margin for Q3 hit 50.5%, up approximately 800 basis points from 46.8% in the prior year, reflecting successful operational efficiencies and increased sales volumes, enhancing unit economics.
- Market Investment Returns: The company's $1.77 million marketing investment over the past nine months directly contributed to 39% revenue growth, while Q3 marketing spend decreased by 42% year-over-year, indicating improved brand awareness and market presence.
See More
