PhenoMATRIX
Contact for pricing
Regulatory Status Disclosed
Overview
PhenoMATRIX by Copan Diagnostics is an FDA 510(k)-cleared artificial intelligence (AI) software designed for microbiology laboratories. It integrates with the WASPLab® digital workflow to analyze and sort digital images of culture media plates. The tool is intended for use by laboratory technologists in clinical microbiology settings.
- What it does: PhenoMATRIX uses AI, combined with patient information from the Laboratory Information System (LIS) and laboratory-defined expert rules, to automatically sort digital images of culture plates. It detects microbial growth, estimates semi-quantitative and qualitative colony counts, and differentiates isolates based on phenotypic characteristics. The software can also apply results to individual plates or combine interpretations from multiple plates belonging to the same sample.
- Who it is for: PhenoMATRIX is for microbiology laboratories, particularly those utilizing Copan’s WASPLab® system, to assist laboratory technologists in processing and interpreting culture results.
- How it fits a clinical or practice workflow: PhenoMATRIX streamlines the microbiology workflow by automatically sorting culture plate images based on laboratory-defined classification parameters. This allows technologists to prioritize plates requiring further evaluation and can suggest results for cultures, which technologists can then accept or modify. It can also facilitate reporting to the LIS. An optional feature, PhenoMATRIX® with Auto-Release PLUS, can automatically release negative plates directly to the LIS without manual review, flagging potential positives for technician validation.
- Notable capabilities: Key capabilities include automated detection of microbial growth, semi-quantitative and qualitative colony counting, and differentiation of isolates based on phenotypic characteristics. It integrates LIS data and laboratory-defined expert rules for customized sorting and interpretation. When combined with the Colibrí™ instrument, PhenoMATRIX® TAG functionality can analyze plate images, identify colonies of interest, and communicate coordinates for automated identification and susceptibility testing workflows. The system supports early reading of culture plates for certain pathogens.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- Detects microbial growth
- Estimates semi-quantitative and qualitative colony counts
- Differentiates isolates based on phenotypic colony characteristics
- Automatically sorts culture plate images according to laboratory-defined classification parameters
- Streamlines negative plate review
- Automatically assigns suggested results to culture plate images
- Supports integration with WASPLabu00ae digital workflow
- Analyzes high-resolution culture images and sorts them based on various criteria
- TAG* functionality for identifying colonies of interest for automated ID and AST workflows with Colibru00edu2122
- Auto-Release PLUS* functionality for automatically sorting and releasing negative plates directly to the LIS
Use Cases
- Automated interpretation of bacterial culture plates
- Streamlining negative and insignificant culture review
- Increasing efficiency and consistency in microbiology laboratory workflows
- Supporting automated ID and AST workflows
- Empowering laboratory staff by automating routine tasks
- Standardizing workflow while preserving technologist oversight
What Physicians Need to Know
LIS/LIMS Integration
PhenoMATRIXu00ae is FDA 510(k)-cleared software that integrates with Laboratory Information Systems (LIS) to combine AI-driven image analysis with patient information and laboratory-defined expert rules. This bidirectional communication allows for efficient exchange of patient demographics, clinical data, and other test results to support interpretation and streamline reporting. PhenoMATRIXu00ae PLUS can automatically release negative results directly to the LIS without manual review.
Supported Assay Types
PhenoMATRIXu00ae supports automated image assessment and sorting of various culture media plates, including blood-based, chocolate, MacConkey, and CHROMagar orientation media. It is used for urine cultures, antibiotic resistance screening (e.g., MRSA, VRE, ESBL, GBS), vaginal swabs, and respiratory tract infections. The system can detect microbial growth, estimate semi-quantitative and qualitative colony counts, and differentiate isolates based on phenotypic characteristics.
QC/QA Features
PhenoMATRIXu00ae applies laboratory-defined expert rules and image analysis results to organize plates for efficient technologist review, ensuring consistency and reproducibility. The software's rigorous application of interpretation rules and thresholds leads to more objective and reproducible results compared to manual interpretation. PhenoMATRIXu00ae TAG uses advanced algorithms to ensure the selection of optimal and isolated colonies for downstream identification and susceptibility testing, reducing errors and standardizing the process.
Result Interpretation AI
PhenoMATRIXu00ae utilizes artificial intelligence and deep learning techniques to automatically sort digital images of culture media plates. It detects microbial growth, estimates colony counts, and differentiates isolates based on phenotypic colony characteristics such as color, morphology, and hemolysis patterns. The AI combines image analysis with LIS data and custom expert rules to suggest final assessments and prioritize plates for technologist review.
Critical Value Alerts
While not explicitly stated as 'critical value alerts' in the traditional sense, PhenoMATRIXu00ae's ability to automatically sort and flag plates with potential positives for technician validation, while routing insignificant or negative results for automated release, effectively prioritizes critical samples for immediate attention. The system's integration with LIS data and custom rules allows for patient-oriented decisions, which can indirectly support the identification of critical cases.
Instrument Interfaces
PhenoMATRIXu00ae is an optional software addition to the WASPLabu00ae digital microbiology workflow. When combined with PhenoMATRIXu00ae TAG functionality, it communicates colony coordinate information to the Colibru00edu2122 instrument to support automated ID and AST workflows.
Reference Range Intelligence
PhenoMATRIXu00ae incorporates laboratory-defined expert rules and thresholds for interpreting microbial growth, including semi-quantitative assessment of microbial load and determination of culture purity. For urine cultures, it can segregate results based on colony counts (e.g., No Growth, 10 cfu) and classify cultures into Normal Genitourinary Flora or Significant Positive Cultures. This allows for customized interpretation based on laboratory standards.
Turnaround Time Impact
PhenoMATRIXu00ae significantly reduces turnaround time (TAT) by automating the sorting and preliminary interpretation of culture plates. Studies have shown reductions in time to final culture reporting for urine samples, with decreases of approximately 1.5 to 3.9 hours, and up to 14 hours reduction from manual to fully automated workflow, with 8 hours attributed to image analysis. PhenoMATRIXu00ae PLUS further improves TAT by automatically releasing negative plates directly to the LIS, eliminating manual review.
Microbiology ID Support
PhenoMATRIXu00ae supports microbiology identification by detecting microbial growth, estimating colony counts, and differentiating isolates based on phenotypic characteristics. PhenoMATRIXu00ae TAG automatically selects and 'tags' the best colonies for picking by the Colibru00edu2122 instrument for subsequent MALDI-TOF ID and Antimicrobial Susceptibility Testing (AST).
Physician Tip
PhenoMATRIXu00ae streamlines microbiology diagnostics by providing rapid, AI-assisted interpretation of culture plates, leading to faster turnaround times for results, especially for negative cultures. This allows clinicians to receive actionable information sooner, potentially impacting treatment decisions and patient outcomes. The system's ability to integrate with LIS data and apply custom rules ensures that interpretations are tailored to specific clinical contexts and laboratory protocols. For positive cultures, the automated tagging for ID/AST can expedite further workup, leading to quicker identification of pathogens and determination of antimicrobial susceptibility.
PhenoMATRIXu00ae is designed to integrate seamlessly within the COPAN WASPLabu00ae full laboratory automation ecosystem. It offers robust bidirectional LIS integration for comprehensive data exchange, including patient demographics and clinical history. The PhenoMATRIXu00ae TAG functionality directly interfaces with the Colibru00edu2122 automated colony picking instrument for streamlined ID and AST workflows. It is also optimized for use with CHROMIDu00ae chromogenic plated media, enhancing its detection capabilities for various organisms.
Details
| Category | Lab & Diagnostics, Pathology AI |
| Pricing | Contact for pricing |
| Deployment | On-premise (integrated with WASPLab®) |
| Compliance | |
| BAA Available | Unknown AI-estimated |
| HIPAA Compliant | Unknown AI-estimated |
| FDA Status |
1 AI-estimated PhenoMATRIX® is FDA 510(k) cleared (K251511) as a Class II Device for its intended use, marking a significant milestone in digital microbiology innovation. Certain additional configurations are labeled Research Use Only (RUO) in the United States. |
| Integrations | |
| EHR | Not specified |
| Specialties | Infectious Disease, Laboratory Medicine |
What the Web Says
PhenoMATRIX is an AI-powered software suite designed for clinical microbiology laboratories, primarily integrating with Copan's WASPLab automation system. It automates the reading, interpretation, and segregation of bacterial cultures from digital images, aiming to improve efficiency, reduce workload, and enhance accuracy in diagnostics. The system uses advanced algorithms and laboratory-defined expert rules to sort plates, identify growth, and even suggest pathogen types, allowing microbiologists to focus on more complex cases.
Overall: PositiveStrengths
- Significantly reduces manual workload for laboratory technologists, especially for negative cultures.
- Improves turnaround time (TAT) for patient results, leading to earlier treatment decisions.
- Enhances accuracy and reproducibility of culture interpretation by overcoming human subjectivity and rigorously applying expert rules.
- Automates colony selection for further identification and susceptibility testing (with PhenoMATRIX TAG and Colibru00ed integration).
- Can detect more true positive cultures than manual review in some cases, and has high sensitivity and specificity for various pathogens.
- Offers customizable expert rules to align with specific laboratory protocols and standards.
Limitations
- Interpretation of some samples still lacks strict quantitative criteria, requiring microbiologist expertise.
- The system still requires trained laboratory personnel for final assessment and result definition, as it supports rather than replaces microbiologists.
- Potential for false positives in some screenings, which still require manual review for confirmation.
- The definition of analytical and clinical performance can be complicated by the lack of a gold standard for microbial growth interpretation.
- No specific negative reviews from physicians, healthcare IT, tech reviewers, Reddit, G2, or Capterra were found for PhenoMATRIX itself in the search results. However, general concerns about AI automation in other contexts include implementation challenges and the need for thoroughness in automated tasks.
Based on reviews from: Copan Group, Copan Diagnostics, Clinical Lab Products, Frontiers, BioSpace, PubMed, YouTube
Last updated: 2026-10-05
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Press & Coverage
Copan Diagnostics
PhenoMATRIXu00ae Receives FDA 510(k) Clearance: Advancing Digital Microbiology with Confidence
Copan announced that its PhenoMATRIXu00ae system received FDA 510(k) clearance as a Class II medical device, confirming its use as a Microbial Colony Image Assessment System and an optional module of the WASPLabu00ae automation platform. This clearance supports laboratories in automatically sorting digital images of culture media plates using advanced image analysis and laboratory-defined expert rules.
2026-02
BioSpace
FDA 510(k) Clearance Establishes Broad Intended Use for Copan's PhenoMATRIXu00ae, Expanding Clinical Microbiology Capabilities
Copan Group announced FDA 510(k) clearance for PhenoMATRIXu00ae, an automated image assessment software used with WASPLabu00ae full laboratory automation. This clearance establishes its intended use in the U.S. as a Class II device, integrating image analysis with laboratory-defined rules to support digital microbiology review.
2026-02
BioSpace
COPAN Diagnostics Announces Another Giant Step in the Evolution of Artificial Intelligence in Clinical Microbiology
Copan announced the North American launch of PhenoMATRIXu00ae TAG, a colony selection software that automatically chooses isolated colonies on plated media for picking. This enhances PhenoMATRIXu00ae AI software, allowing WASPLabu00ae users to automatically pre-assess and pre-sort culture plates.
2022-01
accessdata.fda.gov
Class 2 Device Recall PhenoMATRIX
A Class 2 Device Recall was initiated for PhenoMATRIX due to the AI-powered bacterial culture plate interpretation and workup software not having Premarket Approval or pre-market notification (510(k)/de novo), posing a potential risk of inaccurate colony count and/or morphology information.
2025-05
Journal of Clinical Microbiology
Evaluation of PhenoMATRIX and PhenoMATRIX PLUS for the screening of MRSA from nasal and inguinal/perineal swabs using chromogenic media
This study evaluated PhenoMATRIX and PhenoMATRIX PLUS for MRSA screening, demonstrating high sensitivity and specificity for both systems in detecting MRSA from nasal and inguinal/perineal swabs using chromogenic media.
2023-12
Copan Diagnostics
WASPLABu00ae AND PHENOMATRIXu00ae AI ARE MAKING WAVES IN CANADA
Copan's WASPLabu00ae and PhenoMATRIXu00ae solutions were implemented at St. Paul's Hospital in Vancouver, marking the first such installation in Western Canada. This automated workflow is significantly improving efficiency and reducing turnaround times for microbiology specimens.
2024-02
Clinical Laboratory News (CLN)
Understanding Laboratory Automation in Clinical Microbiology
This article discusses the increasing adoption of automation in clinical microbiology, highlighting PhenoMATRIX by Copan as an AI-powered system that uses algorithms to detect organisms of interest and segregate urine cultures.
2023-06
ASM Journals
Improving turnaround times with artificial intelligence in microbiology
A dual-center study evaluated the impact of PhenoMATRIX (PM) AI software on urine culture turnaround times in Canadian diagnostic laboratories, showing that PM enabled earlier availability of interpretable results and reduced time to result reporting.
2026-08
Videos
Product demos, reviews, and walkthroughs for PhenoMATRIX.
Copan - PhenoMATRIXu2122
Copan Group
Frequently Asked Questions
PhenoMATRIX is an FDA 510(k)-cleared software that uses artificial intelligence, patient information from the Laboratory Information System (LIS), and laboratory-defined rules to automatically sort digital images of culture media plates. It helps microbiologists by detecting microbial growth, estimating colony counts, and differentiating isolates based on phenotypic characteristics, thereby streamlining the review process and allowing staff to focus on more complex cultures.
PhenoMATRIX has received FDA 510(k) clearance as a Class II medical device, confirming its intended use as a Microbial Colony Image Assessment System and an optional module of the WASPLabu00ae automation platform. This clearance supports laboratories in the automatic sorting of digital images of culture media plates using advanced image analysis and laboratory-defined expert rules.
PhenoMATRIX integrates with the WASPLabu00ae automation platform and the LIS, applying laboratory-defined expert rules and image analysis results to organize plates for efficient technologist review. While the system provides automated sorting and presumptive identification, all images are ultimately evaluated by trained laboratory personnel for final assessment and result definition, ensuring critical human expertise is maintained.
While PhenoMATRIX offers significant efficiency gains, some functionalities may not be FDA-cleared for use in the United States, and product availability can vary by region. Additionally, the definition of its analytical and clinical performance can be complex due to the lack of a universal gold standard for interpreting microbial growth on culture plates.
Yes, PhenoMATRIX offers different bundles, including PhenoMATRIX Essentials for urine cultures, PhenoMATRIX Select with expanded detection for specific organisms like MRSA and VRE, and PhenoMATRIX Elite with TAG for automatic colony selection for identification and susceptibility testing. PhenoMATRIX PLUS also allows for automatic release of negative urine samples to the LIS without manual review.
PhenoMATRIX significantly reduces the time spent on manual plate review, especially for negative cultures, allowing microbiologists to quickly release negative results and focus on complex cases. This can lead to decreased turnaround times for results, potentially enabling clinicians to make faster differential diagnoses and initiate patient treatment sooner.
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| Last Verified: 2026-07-07 | First Added: 2026-07-07