Intelligent Bio Solutions Advances with Promising Test Results
Intelligent Bio Solutions Achieves Key Milestones in Testing
Intelligent Bio Solutions Inc. (Nasdaq: INBS), a pioneer in medical technology, has made significant strides in advancing its innovative testing solutions. The completion of in-clinic testing marks a crucial step in the company's journey toward obtaining FDA 510(k) clearance for its non-invasive drug testing methods. The recent testing was designed to validate the company's unique approach, which leverages fingerprint sweat analysis to deliver reliable results quickly.
Insights from Recent Clinical Studies
The clinical studies included a comprehensive pharmacokinetic (PK) study. This study sought to determine whether drugs detected in fingerprint sweat provided results that were comparable or even superior to traditional methods such as blood, saliva, and urine. To ensure robust validation, the company conducted a method comparison and usability study, ensuring that users could effectively operate the drug screening system with confidence.
Collaboration and Results
The completion of the clinical phase was a collaborative effort that highlighted the dedication of Intelligent Bio Solutions and their CRO partners, CenExel and Cliantha. Data from the studies, which included 135 subjects administered codeine and tested through the innovative system, is currently being analyzed. The primary objective was to compare the accuracy of the drug screening system against a traceable laboratory reference method.
Future Steps Toward FDA Submission
Having successfully concluded the in-clinic testing phase, Intelligent Bio Solutions is gearing up for the next steps in the FDA submission process. The company aims to finalize clinical data analysis soon and anticipates submitting its 510(k) package shortly thereafter. Achieving FDA clearance could prove transformative, allowing the launch of their clinically validated product in the market, which holds great promise for various sectors.
Potential Impact on Drug Testing
The initial feedback from these studies has been encouraging, indicating that fingerprint-based testing could become a non-invasive and reliable alternative to conventional drug testing techniques. This innovation is expected to cater to various sectors, including workplaces and government agencies, where drug testing is essential.
About Intelligent Bio Solutions Inc.
Intelligent Bio Solutions Inc. (NASDAQ: INBS) is redefining medical testing with its rapid, non-invasive drug testing solutions. The company’s Intelligent Fingerprinting Drug Screening System is designed to analyze fingerprint sweat, providing accurate and timely results. This hygienic and cost-effective system tests for commonly used drugs, making it an invaluable resource for safety-sensitive industries.
Expanding Potential Applications
With sample collection taking mere seconds and results available in under ten minutes, this technology is not only a boon for employers in safety-critical fields but also presents opportunities to extend its applications across various domains. The company is actively exploring potential markets, aiming to establish a solid customer base beyond the US, focusing on sectors such as construction, manufacturing, transport, and drug treatment organizations.
Frequently Asked Questions
1. What is the significance of the in-clinic testing completion?
The completion of in-clinic testing is vital as it brings Intelligent Bio Solutions closer to obtaining FDA 510(k) clearance, enabling them to market their innovative testing solutions.
2. How does the fingerprint sweat testing work?
The fingerprint sweat testing measures drug concentrations in sweat, aiming to provide results that are comparable or superior to traditional testing methods like blood or urine analysis.
3. What sectors could benefit from this technology?
Various sectors, including workplaces, government agencies, and drug treatment organizations, stand to benefit from this fast and non-invasive testing method.
4. When does Intelligent Bio Solutions expect to submit its FDA 510(k) application?
The company expects to complete its clinical data analysis and submit the 510(k) package by the end of the fourth calendar quarter.
5. What makes the Intelligent Fingerprinting Drug Screening System hygienic?
This system involves non-invasive sample collection, making it a hygienic alternative to traditional drug testing methods, which often require invasive procedures.
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