Sunday, April 14, 2024

FDA Clears Beckman Coulter DxFLEX Movement Cytometer


Revolutionary APD Detector Know-how Permits Bigger Antibody Panels And Simplifies Compensation

FDA Clears Beckman Coulter Life Sciences DxFLEX Flow Cytometer

Picture Credit score: Beckman Coulter Life Sciences

INDIANAPOLIS – (March 5, 2024) – Beckman Coulter Life Sciences, a worldwide chief in laboratory automation and innovation, has acquired 510(okay) clearance from the Meals and Drug Administration (FDA) to distribute its DxFLEX Scientific Movement Cytometer in the US. Launched regionally in 2020, this development brings the favored benchtop IVD movement cytometry system to American labs whereas increasing testing capabilities. Providing as much as 13-colors,* extra detectors could be activated as laboratory wants evolve with out the necessity to buy extra {hardware}.

“This pioneering development places high-complexity movement cytometry testing inside attain to extra laboratories with out added expense,” mentioned Carsten Lange, Product Supervisor. “The DxFLEX Scientific Movement Cytometer provides extra colours with out including extra considerations, and permits laboratory employees to have larger confidence in outcomes, whereas streamlining workflows and decreasing handbook steps. With extra fluorescence parameters, laboratories can get extra out of specimens and keep away from a tedious compensation course of and the burden that locations on lab employees.”

Praised for its superior sensitivity and determination, the compact DxFLEX Movement Cytometer makes multicolor movement cytometry much less complicated through the use of avalanche photodiode (APD) detector know-how as a substitute of conventional photomultiplier tube (PMT) know-how. The usage of APD know-how simplifies compensation procedures and delivers richer content material evaluation with greater sensitivity to search out dim populations. By comparability, working compensation on a traditional PMT movement cytometer entails important hands-on time, even when options like auto-compensation setup can be found within the software program.

DxFLEX Flow Cytometer

DxFLEX Movement Cytometer. Picture Credit score: Beckman Coulter Life Sciences

The dynamic compensation library simplifies compensation setup, whereas easy-to-learn CytExpert software program lowers labor time and permits work to start proper out of the field for novice customers. The compact DxFLEX Movement Cytometer is obtainable in two configurations, from a three-laser/10-color system to a three-laser/13-color* configuration.

The DxFLEX Movement Cytometer is validated as an in vitro diagnostic gadget for 10-color immunophenotyping with the ClearLLab 10C Reagent System and delivers the one FDA cleared and CE marked built-in leukemia and lymphoma** resolution, which affords all parts wanted, from qc, pattern preparation and antibody panels to evaluation software program and coaching materials. This allows workflows for illnesses corresponding to power leukemia, myeloma, acute leukemia, non-Hodgkin lymphoma, myeloproliferative neoplasm, and myelodysplastic syndrome.

Along with the US, the DxFLEX Movement Cytometer is obtainable in nations that settle for the CE mark as the idea for his or her country-specific registration, together with Europe, China, India and Japan. Study extra concerning the DxFLEX Movement Cytometer, together with the choice to request an in-lab or digital demonstration, by clicking right here.

* DxFLEX is CE marked for 13-color in-vitro diagnostic use. In U.S., DxFLEX is meant to be used as an in-vitro diagnostic gadget for 10-color immunophenotyping with ClearLLab 10C Reagent system. Fluorescence channels FL11 – FL13 and all different makes use of are for analysis use solely.
** Non-Hodgkin Lymphoma solely

About Beckman Coulter Life Sciences

With a relentless mission to empower these searching for solutions to life’s essential scientific questions, Beckman Coulter Life Sciences is a most well-liked laboratory accomplice offering automation and innovation options for Centrifugation, Movement Cytometry, Genomics, Particle Evaluation, and Liquid Dealing with workflows.

With a legacy courting again to 1935, our applied sciences cut back handbook laboratory processes and might present larger pace, accuracy, and superior analytics to speed up solutions with a guiding focus to enhance affected person care and allow pioneering discoveries. Beckman Coulter Life Sciences is headquartered in Indianapolis, Indiana with 11 operational hubs world wide and employs greater than 3,300 associates with greater than 300,000 techniques put in globally. Study extra at beckman.com and by following us on LinkedIn.

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