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Stemcell Technologies Cell Enrichment Kit Nabs FDA De Novo Classification

NEW YORK – Canadian diagnostic firm Stemcell Technologies announced on Tuesday that its hematopoietic cell enrichment kit has received de novo classification from the US Food and Drug Administration. 

The EasySep Human Bone Marrow CD138 Positive Selection Kit can be used to enrich plasma cells expressing the CD138 marker from patient bone marrow samples, which can improve the sensitivity of downstream in vitro diagnostic tests for multiple myeloma, the Canadian company said in a statement. The kit will be available for sale in the US, Canada, the European Union, and the United Kingdom. 

"Creating an IVD product that improves the accuracy of information guiding the treatment of patients with multiple myeloma is a milestone achievement that reflects our commitment to make a positive impact on human health," Stemcell President and CEO Allen Eaves said in a statement. 

According to Stemcell, the FDA has classified the new product type as a hematopoietic cell enrichment kit, or a Class II IVD device for selecting specific cells for use with diagnostic assays as part of the analytical workflow. Hematopoietic cell enrichment kits have not previously been classified as IVD devices by the agency.

The kit is part of Stemcell's portfolio of EasySep immunomagnetic cell isolation technologies, which have been "specifically developed for fast and easy isolation of highly purified cells that are ready for downstream applications," Stemcell said.