The ISO recertification is a positive procedural step for FDA clearance but does not change the company's near-term financial outlook. Monitor for FDA submission updates or clearance decisions on the opiate codeine test, which would be the primary catalyst.
Price Chart
Executive Summary
Intelligent Bio Solutions announced its Intelligent Fingerprinting Drug Screening business has been recertified to ISO 13485:2016 and ISO 9001:2015, aligning with the FDA's updated Quality Management System Regulation (QMSR). This supports the company's ongoing application for FDA clearance of its drug screening system for opiate codeine detection.
Key Facts
- Intelligent Fingerprinting Drug Screening business recertified to ISO 13485:2016, effective October 14, 2026, valid for three years.
- Also recertified to ISO 9001:2015.
- Certification aligns with FDA's QMSR, which incorporated ISO 13485:2016 effective February 2, 2026.
- Company is actively progressing its application for FDA clearance of the Intelligent Fingerprinting Drug Screening System for opiate codeine detection.
- Certification supports continued operations in the U.S., Canada, Europe, and Asia Pacific.
- Company has a market cap of approximately $7M and is an early-stage medical technology company with no disclosed revenue from the system.
Financial Impact
No financial figures disclosed. The certification is a regulatory milestone with no immediate revenue or cost impact stated.
Risk Factors
- FDA clearance for the opiate codeine test is not guaranteed and may be delayed or denied.
- Company has a very small market cap (~$7M) and no disclosed revenue from the fingerprinting system, making it highly speculative.
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 1 press release from GlobeNewswire.
| Document | Accession Number |
|---|---|
| PRESS-RELEASE Data (Synthetic) | press-3346081 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Oct 21, 2026 6d ago | 10-K/A | $1.69 | awaiting T+20 | — | $1.72 (+2.08%) |
Oct 13, 2026 14d ago | 8-K | $1.45 | awaiting T+20 | — | $1.72 (+18.62%) |
Sep 24, 2026 4w ago | EFFECT | $1.71 $1.69 | ▲ +1.46% | ▲ +1.04% | $1.72 (−0.58%) |
Sep 15, 2026 6w ago | S-3 | $1.97 $1.48 | ▼ −24.87% | ▼ −28.05% | $1.72 (−12.69%) |
Sep 11, 2026 6w ago | 8-K | $2.07 $1.51 | ▼ −27.05% | ▼ −29.32% | $1.72 (−16.91%) |
Sep 9, 2026 6w ago | 8-K | $2.24 $1.59 | ▼ −29.02% | ▼ −30.96% | $1.72 (−23.21%) |
Sep 2, 2026 7w ago | 8-K | $2.30 $1.66 | ▲ +27.83% | ▲ +26.64% | $1.72 (+25.22%) |
Aug 19, 2026 9w ago | 8-K | $2.67 $2.05 | ▼ −23.22% | ▼ −21.70% | $1.72 (−35.58%) |
Aug 19, 2026 9w ago | Press Release | $2.67 $2.05 | ▲ +23.22% | ▲ +21.70% | $1.72 (+35.58%) |
Aug 17, 2026 10w ago | Press Release | $3.37 $2.05 | ▼ −39.17% | ▼ −37.19% | $1.72 (−48.96%) |
US Market Status
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