FDA Clears Beckman Coulter Life Sciences’ AQUIOS STEM System

Beckman Coulter Life Sciences has won U.S. Food and Drug Administration (FDA) 510(k) clearance to distribute its AQUIOS STEM System in the United States. The product provides labs with an evolution of the gold standard for hematopoietic stem cell enumeration.
 
Blood cancers account for nearly 10% of cancer diagnoses each year in the United States, with stem cell transplantation used as a common approach to treat leukemia. Launched regionally in 2022, the AQUIOS STEM System enables complete automation for stem cell analysis and minimizes hands-on time by 95%, reduces error-prone steps by 87.5%, and decreases turnaround time.* The system was designed with leading experts in the field and uses a modular approach for automated analysis of CD34+ hematopoietic stem and progenitor cells for in-vitro diagnostics.
 
“Time is incredibly crucial for patients awaiting stem cell transplantation, so we uniquely understood the need to streamline and automate this complex workflow,” said Dr. Andreas Böhmler, director of Strategic Marketing for Clinical Solutions at Beckman Coulter Life Sciences. “This workflow has remained relatively unchanged for nearly 25 years, and the AQUIOS STEM System is part of our commitment to advancing the world of science through innovation. It’s designed to improve efficiency and enable laboratory staff to accelerate their critical work in analyzing and enumerating viable cells to help improve transplant outcomes.”
 
The system runs on the AQUIOS CL Flow Cytometer, the first true load-and-go flow cytometer that combines sample preparation and analysis in one compact platform. Barcoded vials enable full traceability, providing a comprehensive audit trail. A single tube loader also allows for priority treatment of emergency samples, empowering laboratory staff to handle urgent requests.
 
For a typical five-day work week with 10 specimen samples per day, the AQUIOS STEM System reduces manual workload by approximately six hours. In addition, it reduces the overall turnaround time from sample preparation to patient result, which is essential for a time-critical test such as CD34+ enumeration.
 
“For our daily routines, an automated stem cell analysis system makes our work easier and is timesaving,” said Hans Veenstra, senior Lab Technician, Laboratory for Hematology at Radboud University Medical Center. “While the samples are running on the AQUIOS CL, there is time to do other work like complex leukemia and lymphoma analysis. Because the AQUIOS CL also does all the gating of the samples, we only have to check if all the gates are okay. It makes our daily routine easier and we can perform more tests at the same time.”
 
The AQUIOS STEM System—comprising the AQUIOS STEM Software for the AQUIOS CL Flow Cytometry System, AQUIOS STEM-Kit Reagents, AQUIOS STEM CD34 Control Cells, and Flow-Check Fluorospheres—is an in-vitro diagnostic medical device for detecting parameters in the most used specimen types.
 
Beckman Coulter Life Sciences is a worldwide resource for tools to help optimize research and manufacturing efficiency. Centrifuges. Particle counters/analyzers. Automated liquid handlers. Flow cytometers. Genomic reagents. All these products—and many more—help improve the productivity of scientists, quality control experts, and others. 
 
* Compared to the predicate method, the Stem-Kit for the FC500 flow cytometer.