Stemcell’s EasySep CD138 Positive Selection Kit is planned to be launched in the US, the European Union, Canada, and the UK. Credit: Business Wire/STEMCELL Technologies.

The US Food and Drug Administration (FDA) has granted de novo classification to STEMCELL Technologies’ EasySep Human Bone Marrow CD138 Positive Selection Kit, a novel in vitro diagnostic (IVD) medical device.

Developed to support cancer diagnostic tests, the kit has been classified as a first-of-its-kind Class II IVD device for haematopoietic cell enrichment.

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This hematopoietic cell enrichment kit enriches plasma cells expressing the CD138 marker (CD138+ cells) from bone marrow samples, which can enhance the sensitivity of subsequent diagnostic tests.

Designed to select specific cells from human whole blood or bone marrow, it is intended for use with diagnostic assays as part of the pre-analytical workflow.

The EasySep CD138 Positive Selection Kit is a part of Stemcell’s EasySep immunomagnetic cell isolation technologies, which are tailored for the rapid and efficient isolation of highly purified cells that are ready for downstream applications.

Stemcell president and CEO Dr Allen Eaves said: “Stemcell is proud to develop the first hematopoietic cell enrichment product identified as an in vitro diagnostic device by the FDA.

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“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 kit is claimed to represent the culmination of several years of work that included the assessment of more than 230 bone marrow aspirates from multiple myeloma patients, limit of detection and interference studies, and precision studies of inter- and intra-laboratory reproducibility.

Stemcell plans to roll out the kit for purchase in the US, the European Union, Canada, and the UK.

Eaves added: “This de novo classification will have a permanent impact on the IVD landscape and paves the way for further innovation.

“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.”

Earlier this year, Stemcell acquired Propagenix, a biotechnology company focused on developing technologies to enable new approaches in regenerative medicine.