FDA Clears Beckman Coulter Life Sciences DxFLEX Flow Cytometer

Revolutionary APD Detector Technology Enables Larger Antibody Panels And Simplifies Compensation

Image Credit: Beckman Coulter Life Sciences

INDIANAPOLIS – (March 5, 2024) – Beckman Coulter Life Sciences, a global leader in laboratory automation and innovation, has received 510(k) clearance from the Food and Drug Administration (FDA) to distribute its DxFLEX Clinical Flow Cytometer in the United States. Launched regionally in 2020, this advancement brings the popular benchtop IVD flow cytometry system to American labs while expanding testing capabilities. Offering up to 13-colors,* additional detectors can be activated as laboratory needs evolve without the need to purchase additional hardware.

“This pioneering advancement puts high-complexity flow cytometry testing within reach to more laboratories without added expense,” said Carsten Lange, Product Manager. “The DxFLEX Clinical Flow Cytometer adds more colors without adding more concerns, and enables laboratory staff to have greater confidence in results, while streamlining workflows and reducing manual steps. With more fluorescence parameters, laboratories can get more out of specimens and avoid a tedious compensation process and the burden that places on lab staff.”

Praised for its superior sensitivity and resolution, the compact DxFLEX Flow Cytometer makes multicolor flow cytometry less complex by using avalanche photodiode (APD) detector technology instead of traditional photomultiplier tube (PMT) technology. The use of APD technology simplifies compensation procedures and delivers richer content analysis with higher sensitivity to find dim populations. By comparison, running compensation on a conventional PMT flow cytometer involves significant hands-on time, even when features like auto-compensation setup are available in the software.

DxFLEX Flow Cytometer. Image Credit: Beckman Coulter Life Sciences

The dynamic compensation library simplifies compensation setup, while easy-to-learn CytExpert software lowers labor time and enables work to begin right out of the box for novice users. The compact DxFLEX Flow Cytometer is available in two configurations, from a three-laser/10-color system to a three-laser/13-color* configuration.

The DxFLEX Flow Cytometer is validated as an in vitro diagnostic device for 10-color immunophenotyping with the ClearLLab 10C Reagent System and delivers the only FDA cleared and CE marked integrated leukemia and lymphoma** solution, which offers all components needed, from quality controls, sample preparation and antibody panels to analysis software and training material. This enables workflows for diseases such as chronic leukemia, myeloma, acute leukemia, non-Hodgkin lymphoma, myeloproliferative neoplasm, and myelodysplastic syndrome.

In addition to the United States, the DxFLEX Flow Cytometer is available in countries that accept the CE mark as the basis for their country-specific registration, including Europe, China, India and Japan. Learn more about the DxFLEX Flow Cytometer, including the option to request an in-lab or virtual demonstration, by clicking here.

* DxFLEX is CE marked for 13-color in-vitro diagnostic use. In U.S., DxFLEX is intended for use as an in-vitro diagnostic device for 10-color immunophenotyping with ClearLLab 10C Reagent system. Fluorescence channels FL11 - FL13 and all other uses are for research use only.
** Non-Hodgkin Lymphoma only

About Beckman Coulter Life Sciences

With a relentless mission to empower those seeking answers to life’s important scientific questions, Beckman Coulter Life Sciences is a preferred laboratory partner providing automation and innovation solutions for Centrifugation, Flow Cytometry, Genomics, Particle Analysis, and Liquid Handling workflows.

With a legacy dating back to 1935, our technologies reduce manual laboratory processes and can provide greater speed, accuracy, and advanced analytics to accelerate answers with a guiding focus to improve patient care and enable pioneering discoveries. Beckman Coulter Life Sciences is headquartered in Indianapolis, Indiana with 11 operational hubs around the world and employs more than 3,300 associates with more than 300,000 systems installed globally. Learn more at beckman.com and by following us on LinkedIn.