Intelligent Bio drug test hits 98.2% accuracy
Company says the new study data complete the clinical part of its FDA 510(k) package and expects a September 2026 510(k) submission.
Rhea-AI Filing Summary
Intelligent Bio Solutions Inc. (INBS) reported new clinical performance data for its Intelligent Fingerprinting Drug Screening System to detect the opiate codeine. In a multi-site U.S. Method Comparison Study, the System achieved overall 98.2% accuracy, 94.6% sensitivity, and 100% specificity across pre-employment and workplace screening settings.
The results, measured against a validated LC-MS/MS reference method, reflect an increase from a prior study that showed approximately 94% accuracy and 82% sensitivity, while maintaining 100% specificity. The company states these data complete the clinical component of its FDA 510(k) package and expects to submit its 510(k) application for the System in September 2026 as part of its planned entry into the U.S. market following FDA clearance.
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8-K Event Classification
2 items: 7.01, 9.01
2 items
Item 7.01
Regulation FD Disclosure
Disclosure
Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.
Item 9.01
Financial Statements and Exhibits
Exhibits
Financial statements, pro forma financial information, or exhibit attachments filed with this report.
Key Figures
Overall accuracy: 98.2%
Overall sensitivity: 94.6%
Specificity: 100%
+5 more
8 metrics
Overall accuracy
98.2%
Total accuracy for Intelligent Fingerprinting Drug Screening System across three sites
Overall sensitivity
94.6%
Total sensitivity for codeine detection in the Method Comparison Study
Specificity
100%
Specificity for codeine detection at each site and in total
True negatives
144
Total true negative samples across all three clinical sites
True positives
70
Total true positive samples across all three clinical sites
False negatives
4
Total false negative samples across all three clinical sites
Prior study accuracy
approximately 94%
Accuracy reported in the company’s previous Method Comparison Study
Prior study sensitivity
approximately 82%
Sensitivity reported in the company’s previous Method Comparison Study
Key Terms
Method Comparison Study, sensitivity, specificity, FDA 510(k) submission, +1 more
5 terms
Method Comparison Study medical
"the results of its latest Method Comparison Study for its Intelligent"
sensitivity medical
"evaluated the sensitivity, specificity, and accuracy of the Intelligent"
specificity medical
"The System’s 100% specificity, unchanged from the prior study, continues"
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.
FDA 510(k) submission regulatory
"supporting Planned 2026 FDA 510(k) Submission Multi-site clinical study"
An FDA 510(k) submission is a regulatory filing to show a new medical device is sufficiently similar to an already-approved device so it can be marketed in the U.S. without undergoing the most extensive premarket review. For investors, 510(k) clearance is a key milestone that reduces regulatory uncertainty and shortens time to sales—think of it as proving a new product is close enough to an established model to be sold without rebuilding trust from scratch.
liquid chromatography-tandem mass spectrometry (LC-MS/MS) technical
"Results were measured against a validated liquid chromatography-tandem mass"
Liquid chromatography-tandem mass spectrometry (LC-MS/MS) is an advanced laboratory technique used to identify and measure small molecules and chemicals in complex samples with high precision. Think of it as a highly sensitive sorting and detection system that separates substances and then precisely analyzes their composition. This method is important to investors because it helps ensure the safety, quality, and authenticity of products like medicines and food, which can impact company performance and market trust.
FAQ
What did INBS announce in its September 1, 2026 Form 8-K?
INBS announced results from a multi-site U.S. Method Comparison Study of its Intelligent Fingerprinting Drug Screening System for codeine detection, reporting 98.2% accuracy, 94.6% sensitivity, and 100% specificity, and indicated these data support its planned FDA 510(k) submission.
How accurate is Intelligent Bio Solutions’ drug screening system according to the new study?
The study reports overall 98.2% accuracy for INBS’s Intelligent Fingerprinting Drug Screening System in detecting the opiate codeine, with 94.6% sensitivity and 100% specificity, based on testing across three independent U.S. clinical sites in workplace and pre-employment settings.
How do the new INBS study results compare with the prior 2024 study?
The new study shows accuracy above 98% versus approximately 94% previously, and sensitivity above 94% versus approximately 82% in the prior study, while maintaining 100% specificity in both studies for codeine detection.
When does INBS expect to submit its FDA 510(k) for the fingerprint drug screening system?
INBS states that, with data collection complete and the new Method Comparison Study results available, it has accelerated its timeline and expects to submit its FDA 510(k) application in September 2026 for the Intelligent Fingerprinting Drug Screening System.
What reference method was used in the INBS codeine detection study?
Performance of the Intelligent Fingerprinting Drug Screening System was measured against a validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) reference method, which served as the comparator for determining true positive, true negative, false positive, and false negative results.
How many clinical sites participated in INBS’s Method Comparison Study?
The Method Comparison Study for INBS’s Intelligent Fingerprinting Drug Screening System was conducted across three independent U.S. clinical sites, which together generated the combined performance metrics reported for codeine detection.
AI-generated analysis. How Rhea-AI works. Not financial advice.
