DxFLEX 10C Clinical Study

Completed

Conditions studied: Hematological Malignancy

In brief

A multi-center method comparison study is designed per CLSI-EP09 A3. This study compares the qualitative immunophenotype agreement between DxFLEX and Navios EX to demonstrate the accuracy of the DxFLEX-10C system. A series of precision studies will be conducted with each focusing on different aspects of the DxFLEX-10C system.

Key facts

Study ID

NCT05467449

Run by

Beckman Coulter, Inc.

People needed

527

Starts

2022-04-12

Expected to finish

2023-08-31

Last updated by the study team

2024-02-13

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• There are two (2) groups of exclusion criteria to detail the specimens that should not be counted for the study:
• Pre-analytical/Pre-screen exclusion criteria
• Post-acquisition exclusion criteria.

Where it is running

• NeoGenomics Laboratories — Aliso Viejo, California, United States
• University of Miami Miller School of Medicine — Miami, Florida, United States
• Quest Diagnostics — Lewisville, Texas, United States
• PhenoPath Laboratories, PLLC — Seattle, Washington, United States
• London Health Sciences Centre — London, Ontario, Canada
• Munich Leukemia Laboratory (MLL) — Munich, Germany

Full record on ClinicalTrials.gov

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