Colibri™ Automated Specimen Workup Instrument by COPAN Receives FDA 510(k) Clearance for Use with MALDI-TOF Mass Spectrometry Analyzers

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Jan 05, 2022, 19:54 ET

MURRIETA, Calif., Jan. 5, 2022 /PRNewswire/ -- COPAN Diagnostics is proud to announce the FDA clearance of Colibri™, an automated processor that is a complementary part of WASPLab®, COPAN's full laboratory automation system. The COPAN Colibri™ System is an in vitro diagnostic device for use in conjunction with the bioMérieux VITEK® MS or Bruker MALDI Biotyper® CA mass spectrometry systems for automating rapid identification of isolated colonies of Gram-negative and Gram-positive bacteria grown on solid culture media. The Colibri™ system, paired with COPAN's revolutionary artificial intelligence (AI) software, PhenoMATRIX®, offers clinical Microbiology laboratories cutting-edge, intelligence driven solutions for specimen workup to help streamline workflow and address the most challenging demands in the laboratory.

Colibri™ Automated Specimen Workup Instrument by COPAN Receives FDA 510(k) Clearance for Use with MALDI-TOF Mass Spectrometry Analyzers

"Clinical Microbiology is facing tremendous challenges including labor shortages, dramatically increased workloads, pressure for on-demand testing and rapid turnaround times for results. The FDA clearance of COPAN's Colibri™ will provide time and labor savings by automating a crucial step in diagnostic Microbiology. When used with COPAN's advanced AI software, the laboratory has total traceability and precision when it comes to colony selection and transfer to MALDI-TOF target slides. A complex task that occurs in Microbiology laboratories tens or hundreds of thousands of times per day which requires great care and attention is now automated with unquestionable accuracy. With this critical process in laboratory workup automated and interfaced with downstream mass spectrometry instruments, experienced laboratory professionals may now use their scarce time to perform other complex tasks requiring their unique skill and expertise." said COPAN Diagnostics' CEO Norman Sharples.

About Colibri™:

COPAN's Colibri™ is unlike any other instrument in Microbiology. It automatically picks isolated colonies for further workup and investigations. Colonies are designated by the laboratory technologist or automatically by COPAN's advanced AI, PhenoMATRIX® TAG. Colibri™ works with both VITEK® MS MALDI-TOF and Bruker Biotyper® systems seeding either manufacturers' target plate formats, automatically applying matrix, and through a software interface, sending instructions and coordinates identifying each individual culture workup spot. The precision robotics of the full laboratory automation system WASPLab® combined with Colibri™ help to eliminate any potential transposition errors. Colibri™ can also seed colonies into various size tubes or bottles to prepare McFarland suspensions for antibiotic susceptibility testing (AST)* verifying opacity of suspensions using the onboard nephelometer. The system applies barcode labels to tubes and prepares purity check plates from these suspensions.

*AST capability currently IUO (Investigational Use Only) in the USA market. Always consult product inserts and instructions for use for the appropriate use of the products. Product clearance and availability restrictions may apply in some countries.

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 pre-assess and pre-sort culture plates and segregate bacterial cultures. PhenoMATRIX® allows laboratories to quickly view and discard the up to 80% of negative cultures which are processed in clinical Microbiology with the click of a button.

About PhenoMATRIX® TAG is the next evolution of COPAN's advanced AI, which automatically detects and "tags" the best colonies to be picked by Colibri™ for workup. The advanced AI can interpret growth based on each laboratory's custom rules, presumptively identify colonial morphology, and pre-select the best isolated colonies for workup. The PhenoMATRIX® TAG software highlights isolated colonies as well as aggregated colonies; colonies which are not fully isolated but determined by the software to be identical and thus pure. After defining the optimal colonies for selection, PhenoMATRIX® TAG communicates the colony coordinates to the Colibri™ 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 approved system for planting and streaking.

To learn more about Colibri™ and PhenoMATRIX® TAG, 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 in the world. COPAN's collaborative approach to pre-analytics has resulted in FLOQSwabs®, ESwab™, UTM Universal Transport Medium®, laboratory automation including WASP® and WASPLab®. For more information, visit www.copanusa.com

SOURCE COPAN Diagnostics, Inc.