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 popular AQUIOS STEM system in the United States. This innovation provides laboratories with an evolution of the gold standard for hematopoietic stem cell enumeration.
Image credit: Beckman Coulter Life Sciences
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 treating leukemia. Launching regionally in 2022, the AQUIOS STEM system enables full automation for stem cell analysis and minimizes hands-on time by 95%, reduces error-prone steps by 87.5% and reduces turnaround time.* The system was designed with leading experts in the field and uses a modular approach for automated analysis of CD34+ hematopoietic stem cells and progenitor cells for in vitro diagnostics.
Time is incredibly critical for patients awaiting a stem cell transplant, so we uniquely understood the need to streamline and automate this complex workflow. This workflow has remained relatively unchanged for nearly 25 years, and the AQUIOS STEM system is part of our commitment to advance the world of science through innovation. It is designed to improve efficiency and enable laboratory staff to accelerate their critical work of analyzing and enumerating viable cells to help improve transplant outcomes.”
Dr. Andreas Böhmler, Strategic Marketing Director for Clinical Solutions
The system works with the AQUIOS CL flow cytometer, the first true loading and transition flow cytometer that combines sample preparation and analysis in a compact platform. Barcoded vials allow full traceability, providing a complete audit trail. A single-tube loader also allows priority processing of emergency samples, enabling laboratory staff to handle urgent requests.
For a typical 5-day work week with 10 samples per day, the AQUIOS STEM system reduces the manual workload by approximately 6 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 saves time,said Hans Veenstra, Senior Laboratory Technician, Hematology Laboratory at Radboud University Medical Center. “While the samples are being run on the AQUIOS CL, there is time to do other work such as complex leukemia and lymphoma analysis. Since the AQUIOS CL also does all the gating of the samples, we only need to check if all the gates are OK. It makes our daily life easier and we can do more tests at the same time.”
The AQUIOS STEM System, consisting of 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 (IVD) medical device intended to be used by laboratory professionals to detect parameters in the most used sample types.
