Latest Beckman Coulter Clinical Flow Cytometry Product Gains FDA Clearance

Workflow-Efficient Navios EX Flow Cytometer for Immunophenotyping in the Clinical Lab

SAN DIEGO, CALIF. – (July 31, 2017) – Beckman Coulter Life Sciences has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its latest clinical flow cytometry product, the Navios EX flow cytometer, to be used in the clinical laboratory in the US. The Navios EX delivers accurate, high complexity immunophenotyping using Tetra reagents. The compact, 10-color Navios EX incorporates the advanced optics and laser technology of the company’s award-winning CytoFLEX research flow cytometer.

The company is launching the Navios EX at the 69th American Association for Clinical Chemistry (AACC) Annual Scientific Meeting and Clinical Laboratory Expo (CLE), being held July 31 - August 3, 2017 in San Diego. Beckman Coulter Life Sciences, part of the Danaher Corporation, is exhibiting on booth #3117 alongside Beckman Coulter Diagnostics (another Danaher company).**

Accuracy, Sensitivity, Standardization of Results, with Improved Throughput

The Navios EX delivers up to 12 parameters*, needed for high complexity assays. It uses three solid-state lasers at 488nm, 638nm* and 405nm* enabling it to perform fast, accurate correlated multiparameter analyses of individual cells.

Further workflow efficiencies include automated data management, tracking samples throughout the testing process with the platform able to communicate bi-directionally with the central Laboratory Information System (LIS).

“The Navios EX provides a standardized and fast solution for advanced flow cytometry applications requiring quality, reproducibility and sensitivity,” explained Dr Mario Koksch, vice president and general manager of Beckman Coulter’s Cytometry Business Unit. “This makes it especially valuable for use, for example, in clinical trials or other highly regulated events where multi-site comparable results are essential.”

With 20-bit resolution, the system offers 1,048,576 channels of dynamic range. The powerful lasers and integrated optics from the company’s CytoFLEX*** instrument provide clear, accurate population resolution. With two different forward scatter angles, the Navios EX offers the flexibility of small particle detection as well as dim fluorescent population analysis.

The system has been designed to maintain a stable, consistent performance over long periods of time across a wide range of operating temperatures. The system’s digital pulse processing design has a 40 MHz sampling rate able to collect a great amount of data per event. This reduces errors and preserves sensitivity and resolution at high event rates. Even at approximately 25,000 events, the Navios EX maintains a 90% event processing efficiency.

Fully compatible with automated sample preparation modules, the Navios EX provides a seamless workflow solution. Its thermoregulation system maintains the optical area at a consistent temperature, assuring reliable data while limiting laser downtime and maintaining compensation settings.

“By automating workflow, the 10-color Navios EX system delivers a standardized, automated workflow which minimizes user variability and reduces manual steps,” added Dr Koksch. “However,
alongside speed and performance benefits, assay quality is fundamental to ensure clinical research teams have the confidence to meet today’s rigorous quality assurance obligations.”

The introduction of the Navios EX flow cytometer further expands the portfolio of clinical diagnostic solutions offered by the diagnostic companies of Danaher Corporation, which include Beckman Coulter, Cepheid, Leica Biosystems, Radiometer, and SCIEX Diagnostics. The breadth of this portfolio extends from the established to novel diagnostic technologies for clinical and anatomic pathology laboratories and point-of-care testing. With a rich history and a tradition of innovation, the diagnostic companies of Danaher remain committed to developing new and unique diagnostic approaches for better, integrated patient care, and to helping the healthcare systems build comprehensive and efficient diagnostic services with a high degree of automation, standardization, and connectivity.

* In U.S., Navios EX is intended for use as an in vitro diagnostic device for immunophenotyping with Navios tetra software and CYTO-STAT tetraCHROME reagents. All other uses are for research use only.
** Beckman Coulter Life Sciences is a separate company from Beckman Coulter Diagnostics and produces clinical flow cytometry systems for both Danaher companies.
*** For Research Use Only. Not for Diagnostic Purposes.

Beckman Coulter, Navios EX, Tetra and the stylized logo are trademarks of Beckman Coulter, Inc. and are registered with the USPTO.