FDA clears Beckman Coulter Life Sciences AQUIOS STEM System for stem cell evaluation

Beckman Coulter Life Sciences, a worldwide chief in laboratory automation and innovation, has obtained 510(okay) clearance from the Meals and Drug Administration (FDA) to distribute its well-liked AQUIOS STEM System in the US. This innovation gives labs with an evolution of the gold customary for hematopoietic stem cell enumeration.

Picture Credit score: Beckman Coulter Life Sciences

Blood cancers account for practically 10% of most cancers diagnoses annually in the US, with stem cell transplantation used as a standard method to deal with leukemia. Launched regionally in 2022, the AQUIOS STEM System permits full automation for stem cell evaluation and minimizes hands-on time by 95%, reduces error-prone steps by 87.5%, and reduces turnaround time.* The system was designed with main specialists within the area and makes use of a modular method for automated evaluation of CD34+ hematopoietic stem and progenitor cells for in vitro diagnostics.

Time is extremely essential for sufferers awaiting stem cell transplantation, so we uniquely understood the necessity to streamline and automate this complicated workflow. This workflow has remained comparatively unchanged for practically 25 years, and the AQUIOS STEM System is a part of our dedication to advancing the world of science by means of innovation. It is designed to enhance effectivity and allow laboratory workers to speed up their vital work in analyzing and enumerating viable cells to assist enhance transplant outcomes.”

Dr. Andreas Böhmler, Director of Strategic Advertising for Medical Options

The system runs on the AQUIOS CL Circulation Cytometer, the primary true load-and-go move cytometer that mixes pattern preparation and evaluation in a single compact platform. Barcoded vials allow full traceability, offering a complete audit path. A single tube loader additionally permits for precedence therapy of emergency samples, empowering laboratory workers to deal with pressing requests.

For a typical 5-day work week with 10 specimen samples per day, the AQUIOS STEM System reduces handbook workload by roughly 6 hours. As well as, it reduces the general turnaround time from pattern preparation to affected person consequence, which is important for a time-critical check corresponding to CD34+ enumeration.

“For our each day routines, an automatic stem cell evaluation system makes our work simpler and is timesaving,” mentioned Hans Veenstra, Senior Lab Technician, Laboratory for Hematology at Radboud College Medical Heart. “Whereas the samples are operating on the AQUIOS CL, there’s time to do different work like complicated leukemia and lymphoma evaluation. As a result of the AQUIOS CL additionally does all of the gating of the samples, we solely must examine if all of the gates are okay. It makes our each day routine simpler and we will carry out extra checks on the similar time.”

The AQUIOS STEM System, comprised of AQUIOS STEM Software program for the AQUIOS CL Circulation Cytometry System, AQUIOS STEM-Equipment Reagents, AQUIOS STEM CD34 Management Cells and Circulation-Test Fluorospheres, is an in vitro diagnostic (IVD) medical machine supposed for use by laboratory professionals for the detection of parameters in essentially the most used specimen sorts.