Monday, December 23, 2024

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

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Copan Diagnostics, a leader in Clinical Microbiology automation solutions, has announced the third FDA clearance for its innovative pre-analytical processor, Colibrí™. 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 Colibrí™ 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 Colibrí™ Vision System and Colibrí™ Preparation Station.

The latest FDA clearance recognizes the ability of the Colibrí™ instrument to seamlessly integrate with the Beckman Coulter MicroScan Walkaway Instruments & Panels for ID/AST.  The Colibrí™  system automates the preparation of microbial suspensions at a known concentration for the MicroScan system, widely used in clinical laboratories for AST analyses.  Colibri™ 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 Colibrí™ 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.

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

The Colibri™ 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 Colibri™ 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.”

SOURCE: PRNewswire

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