STEMCELL Technologies is pleased to announce that its new EasySep™ Human Bone Marrow CD138 Positive Selection Kit has been granted de novo classification by the U.S. Food and Drug Administration (FDA) as a first-of-its-kind in vitro diagnostic (IVD) medical device for hematopoietic cell enrichment.
The kit can be used to enrich plasma cells expressing the CD138 marker (CD138+ cells) from patient bone marrow samples. Such cell-type-specific enrichment can increase the sensitivity of downstream in vitro diagnostic tests for multiple myeloma—a cancer of plasma cells—to better inform patient risk and course of treatment.
Accounting for approximately 2% of all cancers in the United States1, multiple myeloma is incurable, and variable or low frequencies of CD138+ cells in bone marrow samples can impact the reliability of detecting genetic abnormalities that influence the disease’s progression. Incorporation of STEMCELL's new kit in a pre-analytical step of the diagnostic workflow can contribute to improving patient care and outcomes by enhancing the sensitivity and resolution of these downstream assays.
“STEMCELL is proud to develop the first hematopoietic cell enrichment product identified as an in vitro diagnostic device by the FDA,” said Dr. Allen Eaves, President and CEO, STEMCELL. “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.”
The FDA identifies this new product type as a hematopoietic cell enrichment kit: a Class II IVD device for selecting specific cells from human whole blood or bone marrow, intended for use with diagnostic assays as part of the pre-analytical workflow. Agencies such as the National Comprehensive Cancer Network and the American College of Medical Genetics recommend CD138+ cell enrichment upstream of fluorescence in situ hybridization (FISH) testing for multiple myeloma; however, until now, hematopoietic cell enrichment products have not been classified as IVD devices by the FDA.
“This De Novo classification will have a permanent impact on the IVD landscape and paves the way for further innovation,” said Dr. Eaves. “STEMCELL is committed to building on this foundational work in the IVD field with novel diagnostic products and support, including supporting industry partnerships through our Diagnostics Partnerships and OEM Solutions Program.”
The EasySep™ Human Bone Marrow CD138 Positive Selection Kit is part of STEMCELL’s portfolio of EasySep™ immunomagnetic cell isolation technologies, specifically developed for fast and easy isolation of highly purified cells that are ready for downstream applications.
It marks the culmination of many years of work, which included examining more than 230 bone marrow aspirates from multiple myeloma patients, precision studies of inter- and intra-laboratory reproducibility, and limit of detection and interference studies. The EasySep™ Human Bone Marrow CD138 Positive Selection Kit will be available for sale in the United States, the European Union, Canada, and the United Kingdom.
