Copan Colibrítm Receives Third FDA Clearance, Further Expanding Automated ID/AST Workup Capabilities

MURRIETA, Calif., Jan. 29, 2024 /PRNewswire/ -- Copan Diagnostics, a leader in Clinical Microbiology automation solutions, has announced the third FDA clearance for its innovative pre-analytical processor, Colibrítm. The automated ID/AST preparation instrument is a key component in Copan's full laboratory automation line that revolutionizes the workflow and efficiency of microbiology labs.

The Colibrítm system is a fully automated specimen preparation platform designed to prepare MALDI-TOF ID targets and create bacterial suspensions for Antibiotic Susceptibility Testing (AST). The system comprises of Colibrítm Vision System and Colibrítm Preparation Station.

The latest FDA clearance recognizes the ability of the Colibrítm instrument to seamlessly integrate with the Beckman Coulter MicroScan Walkaway Instruments & Panels for ID/AST.  The Colibrítm  system automates the preparation of microbial suspensions at a known concentration for the MicroScan system, widely used in clinical laboratories for AST analyses.  Colibritm is notably the first instrument in its class to receive 510(k) clearance for the simultaneous preparation of MALDI-TOF slides and AST suspensions. Beckman Coulter is a trusted partner in the distribution of Copan's line of laboratory automation and artificial intelligence (AI). "The integration of the Colibrítm system with our Beckman Coulter MicroScan product is a testament to the strong partnership we have with Copan Diagnostics. We believe that by streamlining workflow through integration, we are one step closer to our goal of ensuring that all patients receive the right antibiotics, at the right time" says Jenn Mason, Senior Director of the Global Marketing and Program Management Office at Beckman Coulter.

In 2022, Copan Announced FDA 510(k) Clearance for Use with MALDI-TOF Mass Spectrometry Analyzers.  Later that year the Colibritm system received FDA 510(k) clearance for use with bioMérieux VITEK^® 2 Antimicrobial Susceptibility Testing System.

The Colibritm system, combined with Copan's cutting-edge AI software, PhenoMATRIX^®, empowers clinical microbiology laboratories with artificial intelligence-driven solutions for specimen workup. This integration streamlines workflow processes and addresses the most demanding laboratory requirements.

"At Copan, we are unwavering in our commitment to support clinical microbiology laboratory professionals. They face unprecedented challenges today, including labor shortages, skyrocketing workloads, and the demand for rapid testing and result delivery," said Fabrizio Mazzocchi, Chief Executive Officer for Copan Diagnostics "This third FDA clearance for Copan's Colibritm opens the door to automated AST workup with another leading system, offering significant time and labor savings by automating a vital step in diagnostic Microbiology.  With this crucial process in laboratory workup automated and integrated with downstream instruments like MicroScan, experienced laboratory professionals can redirect their valuable time towards more complex tasks that require their unique skill and expertise."

About Colibrítm:

Copan's Colibrítm automatically picks isolated colonies for further workup and investigations. Colonies are selected by the laboratory technologist or automatically by Copan's advanced AI, PhenoMATRIX^® TAG. The precision robotics of the full laboratory automation system WASPLab^® combined with Colibrítm help to eliminate transposition errors.

Colibrítm works with both bioMérieux VITEK^® MS and Bruker MALDI Biotyper^® systems, seeding either manufacturers' target plate formats, automatically applying matrix, and automatically sending instructions and coordinates identifying each colony workup spot.

Colibrítm seeds colonies into various-size tubes to prepare McFarland suspensions for AST. The system is now FDA cleared for the preparation of microbial suspensions for AST with Beckman Coulter MicroScan and bioMérieux VITEK 2.

About PhenoMATRIX^®

PhenoMATRIX^® is an unparalleled AI-powered software which uses an advanced selection of highly sophisticated algorithms giving users of Copan's WASPLab^® the power to automatically assess and sort bacterial cultures. PhenoMATRIX^® allows laboratories to quickly view and discard negative and insignificant cultures with the click of a button. 

PhenoMATRIX^® TAG is the next evolution of COPAN's advanced AI, which automatically detects and "tags" the best colonies to be picked by Colibritm for workup.  The advanced AI can interpret growth based on each laboratory's rules, and presumptively identify colonial morphology, pre-selecting the best colonies for workup.  After defining the optimal colonies for selection, PhenoMATRIX^® TAG communicates the colony coordinates to the Colibritm for reliable and accurate picking. 

About Copan Full Laboratory Automation WASPLab^®:

WASPLab^® is a highly efficient, modular, scalable, and customizable specimen processing and culture workup system for Clinical Microbiology. Samples move from front-end processing to smart incubation, digital Microbiology, and artificial intelligence for plate reading. The system accepts any manufacturer's plated media and utilizes the gold standard, CLSI guidelines for planting and streaking.

To learn more about Colibritm visit www.copanusa.com/colibri. 

About Copan Diagnostics, Inc.

Copan Diagnostics is part of Copan Group, a leading manufacturer of collection and transport systems and full laboratory automation.  Copan's collaborative approach to pre-analytics has resulted in FLOQSwabs^®, ESwab^®, UTM^® Universal Transport Mediumtm and full laboratory automation and artificial intelligence.  For more information, visit www.copanusa.com.

SOURCE COPAN Diagnostics, Inc.