STEMCELL-TECHNOLOGIES
26.3.2024 13:01:28 CET | Business Wire | Press release
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.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240326396951/en/
STEMCELL Technologies is pleased to announce that its new EasySep™ Human Bone Marrow CD138 Positive Selection Kit is now classified 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. (Photo: Business Wire)
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.
1Padala et al. 2021 Med Sci (Basel)
About STEMCELL Technologies
STEMCELL Technologies supports life sciences research with more than 2,500 specialized reagents, tools, and services. STEMCELL offers high-quality cell culture media, cell separation technologies, instruments, accessory products, educational resources, and contract assay services that are used by scientists performing stem cell, immunology, cancer, regenerative medicine, and cellular therapy research globally.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240326396951/en/
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Colruyt Group Crosses the 150 Store Milestone With Rollout of Toshiba ELERA® Self Service Store Deployments8.10.2026 07:30:00 CEST | Press release
Toshiba’s ELERA® Self Service successfully deployed across Okay, Okay City, Spar Colruyt Group and Bio-Planet stores in Belgium Toshiba Global Commerce Solutions today announced the successful deployment of its ELERA® Self Service solution across 144 Colruyt Group stores: Okay, Okay City, Spar Colruyt Group and Bio-Planet. Today, 454 self-checkout systems have already been installed year-to-date across 150 stores. The project continues to expand, with an additional 51 stores planned in 2026 and further rollout in 2027. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261007465701/en/ Toshiba’s ELERA® Self Service successfully deployed across Okay, Okay City, Spar Colruyt Group and Bio-Planet stores in Belgium. The deployment was designed to support a fast, intuitive, and customer-friendly checkout experience, while maintaining the personal interaction that remains important within the convenience retail environment. Across the
Fall Clinical 2026: Galderma Presents New Three-Year Nemluvio® Data Showing Deep and Lasting Skin Lesion and Itch Responses in Patients With Atopic Dermatitis Aged 12 and Older8.10.2026 07:00:00 CEST | Press release
New Nemluvio® (nemolizumab) post-hoc data from the ARCADIA long-term extension (LTE) study showed the majority of Week 16 responders maintained deep and lasting skin lesion and itch response for up to three years1 Additional long-term data further demonstrate Nemluvio’s consistent safety profile and sustained efficacy, including improvements in skin clearance, itch, sleep and quality of life in adults with prurigo nodularis up to 148 weeks, and people with atopic dermatitis aged 12 and older up to 152 weeks2,3 Phase II pediatric data will also be presented, with nemolizumab driving meaningful and sustained improvements in children aged 2-11 years with moderate-to-severe atopic dermatitis4 Alongside a product theatre exploring how targeted IL-31 treatment may impact patient outcomes, these findings reinforce Galderma's leadership in advancing treatment goals in atopic dermatitis and prurigo nodularis Galderma (SIX: GALD), the pure-play dermatology category leader, today announced new da
Fuji Electric Joins Helical Fusion as Strategic Investor and Official Partner as Series B Second Close Raises JPY 3.23 Billion8.10.2026 02:00:00 CEST | Press release
Major Japanese industrial players join Helical Fusion as construction of Helix HARUKA advances through a public-private partnership spanning government, national research infrastructure, and Japan’s manufacturing sector Helical Fusion Co., Ltd., a fusion energy company developing a Helical Stellarator with the goal of achieving commercially viable fusion power in the 2030s, today announced the completion of a JPY 3.23 billion (approximately USD 20.6 million) Series B second close. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261007813917/en/ Helical Fusion and new investors for the Series B 2nd close The round marks another expansion of the industrial coalition forming around Helical Fusion’s Helix Program. Fuji Electric Co., Ltd., one of Japan’s major electrical and industrial equipment manufacturers, has joined Helical Fusion as both an investor and an Official Partner of the Helix Program. Other new investors in the sec
New INRIX Parking Scorecard Reveals Cities with the Most Parking, Highest Prices, and Lowest Availability7.10.2026 22:16:00 CEST | Press release
The Scorecard analyzes more than 120 downtown areas across North America and Europe, comparing parking availability, prices and curb use policies INRIX, a leader in transportation analytics and mobility intelligence, today released its first-ever INRIX Parking Scorecard, the largest comparative analyses of downtown parking conditions across North America and Europe. Drawing on parking availability, curb regulations, pricing data and parking infrastructure from more than 120 downtown areas in 14 countries, the report reveals significant differences in parking conditions and how cities allocate curb space. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261007322796/en/ New INRIX Parking Scorecard: Where Downtown Parking Costs Most The Scorecard examines parking availability: the probability of finding a parking space alongside on-street and off-street parking pricing, and curb use policies. The findings show that parking condi
Lattice Collaborates with Arm to Advance Secure, Adaptable AI Data Center Infrastructure7.10.2026 22:00:00 CEST | Press release
Lattice Semiconductor (NASDAQ: LSCC), the low power programmable and platform firmware leader, today announced a collaboration with Arm to enable secure control, management, and platform adaptability for AI infrastructure. Combining Arm® AGI CPU server platforms with Lattice FPGAs and AMI firmware creates a solution that provides advanced security, manageability, connectivity, and flexibility for next-generation AI data center infrastructure. In Arm AGI CPU server platforms, Lattice FPGAs work alongside the CPU and baseboard management controller, with AMI firmware providing platform boot and management capabilities. The Lattice FPGAs act as companion chips providing secure control and management capabilities, enabling platform trust, connectivity, and infrastructure adaptability. Lattice FPGA technology also enables Open Compute Project (OCP)-compliant connectivity between the Host Processor Module (HPM) and Datacenter Secure Control Module (DC-SCM) through the LVDS Tunneling Protocol
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom