{"id":20860,"date":"2023-12-06T14:08:55","date_gmt":"2023-12-06T14:08:55","guid":{"rendered":"https:\/\/clinlabint.com\/?p=20860"},"modified":"2023-12-08T10:54:42","modified_gmt":"2023-12-08T10:54:42","slug":"fda-clears-beckman-coulter-life-sciences-aquios-stem-system-for-stem-cell-analysis-innovation-provides-united-states-with-first-workflow-update-in-25-years","status":"publish","type":"post","link":"https:\/\/clinlabint.com\/fda-clears-beckman-coulter-life-sciences-aquios-stem-system-for-stem-cell-analysis-innovation-provides-united-states-with-first-workflow-update-in-25-years\/","title":{"rendered":"FDA Clears Beckman Coulter Life Sciences AQUIOS STEM System for Stem Cell Analysis"},"content":{"rendered":"
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FDA Clears Beckman Coulter Life Sciences AQUIOS STEM System for Stem Cell Analysis<\/h1>\/ in Product News<\/a> <\/span><\/span><\/header>\n<\/div><\/section>
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Innovation Provides United States with First Workflow Update in 25 Years<\/strong><\/p>\n

INDIANAPOLIS \u2013 (December 4, 2023) \u2013 Beckman Coulter Life Sciences, a global leader in laboratory
\nautomation and innovation, has received 510(k) clearance from the Food and Drug Administration (FDA)
\nto distribute its popular AQUIOS STEM System in the United States.\u00a0\u00a0<\/strong><\/p>\n

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Innovation provides labs with an evolution of the gold standard for hematopoietic stem cell enumeration.<\/p>\n

Blood cancers account for nearly 10% of cancer diagnoses each year in the United States, with stem cell
\ntransplantation used as a common approach to treat leukemia. Launched regionally in 2022, the AQUIOS
\nSTEM System enables complete automation for stem cell analysis and minimizes hands-on time by 95%,
\nreduces error-prone steps by 87.5%, and decreases turnaround time.* The system was designed with
\nleading experts in the field and uses a modular approach for automated analysis of CD34+ hematopoietic
\nstem and progenitor cells for in vitro diagnostics.<\/p>\n

\u201cTime is incredibly crucial for patients awaiting stem cell transplantation, so we uniquely understood the
\nneed to streamline and automate this complex workflow,\u201d said Dr. Andreas B\u00f6hmler, Director of Strategic
\nMarketing for Clinical Solutions. \u201cThis workflow has remained relatively unchanged for nearly 25 years,
\nand the AQUIOS STEM System is part of our commitment to advancing the world of science through
\ninnovation. It’s designed to improve efficiency and enable laboratory staff to accelerate their critical work
\nin analyzing and enumerating viable cells to help improve transplant outcomes.\u201d<\/p>\n

The system runs on the AQUIOS CL Flow Cytometer, the first true load-and-go flow cytometer that
\ncombines sample preparation and analysis in one compact platform. Barcoded vials enable full
\ntraceability, providing a comprehensive audit trail. A single tube loader also allows for priority treatment of
\nemergency samples, empowering laboratory staff to handle urgent requests.<\/p>\n

For a typical 5-day work week with 10 specimen samples per day, the AQUIOS STEM
\nSystem reduces manual workload by approximately 6 hours. In addition, it reduces the overall turnaround
\ntime from sample preparation to patient result, which is essential for a time-critical test such as CD34+
\nenumeration.<\/p>\n

\u201cFor our daily routines, an automated stem cell analysis system makes our work easier and is
\ntimesaving,\u201d said Hans Veenstra, Senior Lab Technician, Laboratory for Hematology at Radboud
\nUniversity Medical Center. \u201cWhile the samples are running on the AQUIOS CL, there is time to do other
\nwork like complex leukemia and lymphoma analysis. Because the AQUIOS CL also does all the gating of
\nthe samples, we only have to check if all the gates are okay. It makes our daily routine easier and we can
\nperform more tests at the same time.\u201d<\/p>\n

The AQUIOS STEM System, comprised of AQUIOS STEM Software for the AQUIOS CL Flow Cytometry
\nSystem, AQUIOS STEM-Kit Reagents, AQUIOS STEM CD34 Control Cells and Flow-Check
\nFluorospheres, is an in vitro diagnostic (IVD) medical device intended to be used by laboratory
\nprofessionals for the detection of parameters in the most used specimen types.
\nFor more information on the AQUIOS STEM System, please click here<\/a>.<\/p>\n<\/div><\/section>
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