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FDA Clears Beckman Coulter Life Sciences AQUIOS STEM System for Stem Cell Analysis

Innovation Provides United States with First Workflow Update in 25 Years

INDIANAPOLIS – (December 4, 2023) – 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.  

Innovation 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. “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 5-day work week with 10 specimen samples per day, the AQUIOS STEM
System reduces 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+

“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, comprised 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 for the detection of parameters in the most used specimen types.
For more information on the AQUIOS STEM System, please click here.