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
CRH to Acquire Aggregate Operations in Denmark and Finland7.10.2026 08:24:00 CEST | Press release
Transaction Advances CRH’s Strategy to Build Aggregates-led, Connected Portfolio Aligned With Growing Infrastructure Megatrends CRH (NYSE: CRH), the leading provider of building materials, today announced that it has signed an agreement to acquire NCC Industry’s operations in Denmark and Finland from NCC AB. NCC Industry develops, produces and sells stone materials and asphalt products for construction and infrastructure projects. In Denmark NCC Industry’s national network of asphalt plants, land and marine based aggregates sites, together with its substantial high-quality reserves, will significantly expand CRH's presence in the market and its exposure to demand from major road, infrastructure and industrial projects. While in Finland NCC Industry’s attractive network of reserve backed hard-rock quarries, backfilling and recycling operations will complement CRH’s existing operations and connected portfolio of businesses in the Finnish market. Peter Buckley, President, CRH Internationa
Exein and Deutsche Telekom IoT Partner to Secure the Next Generation of Connected Devices7.10.2026 08:00:00 CEST | Press release
The companies will combine device-level security with global IoT connectivity to strengthen security for connected devices The partnership follows Exein's $270 million funding round, which included T.Capital, Deutsche Telekom's strategic investment arm, among its backers Exein, a global leader in physical AI and runtime security, today announced a strategic partnership with Deutsche Telekom IoT to bring integrated security to connected devices across Deutsche Telekom IoT’s ecosystem. With its own transatlantic network and around 600 roaming and satellite partners, Deutsche Telekom IoT provides worldwide connectivity for customers across industries and markets. The partnership pairs Exein's device-level security with Deutsche Telekom IoT’s global connectivity capabilities, addressing a gap that is becoming more urgent as intelligent, business-critical applications move directly onto devices operating in the field — robots, drones and industrial machines acting autonomously and making de
Stop Hoping for Secure AI and Start Building It: RSA Agent ID Closes the Agentic Identity Gap for Highly Regulated Industries7.10.2026 06:00:00 CEST | Press release
As AI, sovereignty, and board-level accountability converge on identity, RSA Agent ID enables finance, government, and regulated industries to find and register agents, prove the authority behind every consequential action, and run it where they choose At World Summit AI in the Netherlands, RSA, the identity standard for government agencies, finance, and high-assurance organizations, today announced RSA Agent ID, the agentic identity security platform for highly-regulated industries. RSA Agent ID discovers, secures, and governs AI agents across their lifecycle, letting regulated organizations find and register agents, prove the authority behind every consequential action, and run it where they choose. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261006426797/en/ Three forces are reshaping how organizations operate, and they are arriving at once. AI is transforming work and pushing agents into production faster than securit
The Empire State Building Observation Deck Hosts Annual Run-Up, Presented by NYU Langone Health and Powered by Merrell7.10.2026 04:25:00 CEST | Press release
The Empire State Building (ESB) hosted the 48th Annual Empire State Building Observation Deck Run-Up, presented by NYU Langone Health and powered by Merrell. In several designated heats, more than 200 runners from across the world raced up the building’s 1,576 stairs to reach the finish line on the iconic 86th Floor Observation Deck. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261006766024/en/ The Empire State Building Observation Deck Hosts Annual Run-Up, Presented by NYU Langone Health and Powered by Merrell “Athletes gather from around the globe to participate in the Empire State Building Observation Deck Run-Up, the world’s preeminent tower race,” said Tony Malkin, chairman and CEO of Empire State Realty Trust. “We congratulate all who participated in this ultimate feat of endurance at Tripadvisor’s number one top attraction in the U.S.” Ryoji Watanabe of Japan took first place in the Men’s Elite heat with a time of 1
Phenom Adds Major Headline Speakers as IAMPHENOM Europe Approaches Sold-Out Status6.10.2026 15:30:00 CEST | Press release
Second wave of esteemed speakers to bring real-world guidance on applying AI, agents and automation to improve hiring, development and retention Phenom, the leader in applied AI built to redesign work operations for hiring faster, developing better and retaining longer, today announced the newest wave of speakers for IAMPHENOM Europe 2026, the only applied AI event dedicated to human resources taking place on 4-5 November in Paris, France. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261006714151/en/ Phenom announced the newest wave of speakers for IAMPHENOM Europe 2026, the only applied AI event dedicated to human resources taking place on 4-5 November in Paris, France. The two-day conference gives attendees what other HR events can’t: an inside look at AI agents already in production, automated workflows tailored to specific business contexts and the dramatic results they are already delivering. Across keynotes, customer
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