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
Prodalim Unveils a New Brand Identity Reflecting Its Evolution into a Global Natural Ingredients and Solutions Powerhouse10.9.2026 08:00:00 CEST | Press release
Prodalim, a global leader in juice solutions and specialty ingredients, unveiled today a new brand identity reflecting the company's evolution and accelerated transformation into a global platform delivering high-value natural ingredients and tailored offerings for F&B companies worldwide. The new brand identity celebrates Prodalim's heritage while reflecting the company it has become: a trusted global partner offering a growing portfolio of ingredients, technologies and end-to-end solutions. Supported by its recent successful IPO earlier this year, Prodalim has expanded its specialty ingredients capabilities, helping customers develop natural, clean-label products that meet consumers’ uncompromising expectations for taste, health, and nutrition. "'Taking Nature Further' reflects who we are and what we strive to achieve every day," saidTsahi Barak, Prodalim’s CEO. "By combining nature with science and technology, we help our customers create innovative products that deliver great taste
Tigo Energy Drives Growth for UK Installers With Training, Support, and 211GWh in Optimization10.9.2026 07:00:00 CEST | Press release
Tigo to celebrate nine years of UK market growth, record-breaking Reclaimed Energy for UK Tigo customers, and Loyalty Program awards at Solar & Storage Live UK 2026 trade show. Tigo Energy, Inc. (NASDAQ: TYGO) (“Tigo” or “Company”), a leading provider of intelligent solar and energy software solutions, today announced that the Company will highlight key business and technical milestones in the UK market at the Solar & Storage Live UK 2026 trade show in Birmingham from September 22-24. In the wake of a cross-country installer training tour and the UK market release of the Tigo GO ESS platform, Tigo will focus its 2026 trade show presence in Birmingham on optimization and module-level monitoring with the Tigo TS4 MPLE product family, and welcome UK installers into the Advanced tier of the Tigo Installer Loyalty Program. Since 2017, installers across the United Kingdom have deployed Tigo MLPE devices at more than 20,000 customer sites, with a sharp increase beginning in 2023. With nearly
Ant International, Mastercard and Visa Initiate Collaboration on Know-Your-Agent Interoperability to Scale Agentic Commerce10.9.2026 03:00:00 CEST | Press release
Ant International, Mastercard, and Visa have begun collaboration on a Know-Your-Agent (KYA) interoperability framework, designed to help card networks, digital wallet ecosystems, agent platforms and marketplaces streamline agent onboarding and identification across networks, based on shared principles while preserving each network's own verification and decisioning processes. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260909003891/en/ Ant International, Mastercard and Visa initiate collaboration on Know-Your-Agent interoperability to scale agentic commerce AI agents are evolving from making recommendations to completing purchases on behalf of users. By 2030, AI agents are projected to orchestrate US$3 trillion to 5 trillion of global consumer commercei. Underlying the mega-trend is the KYA architecture of payment networks and service providers, which establishes requirements and accountability, verifies agent identities,
Andersen Global etablerer nyt medlemsvirksomhed i Frankrig9.9.2026 23:00:00 CEST | Pressemeddelelse
Andersen Global styrker sin tilstedeværelse i Frankrig med tilføjelsen af Andersen Société d'Avocats (Andersen in France), en medlemsvirksomhed baseret i Paris, der tilbyder integrerede juridiske ydelser til klienter i Frankrig og internationalt. Andersen in France tilbyder strategiske juridiske løsninger inden for selskabsskat, international skat, transfer pricing, moms og skatteprocesser og bistår klienter over hele verden. Under ledelse af de administrerende partnere Benoît Dambre og François Morazin håndterer det tværfaglige team også specialiserede områder som byplanlægning, fast ejendom, intellektuel ejendomsret og privatlivsbeskyttelse, bæredygtighed og ESG, EU-ret og sanktioner samt andre komplekse juridiske problemstillinger. "Vi ser juridisk rådgivning som mere end blot at håndtere umiddelbare udfordringer – det bør hjælpe klienter med at træffe kvalificerede beslutninger og opsøge muligheder med selvtillid," udtalte Benoît. "At blive en del af Andersen Global giver os muligh
Cyclic Materials Opens America’s First Commercial-Scale Facility Delivering Automated Rare Earth Magnet Recovery9.9.2026 22:09:00 CEST | Press release
The Mesa, Arizona facility deploys Cyclic Materials’ proprietary technology to process up to 25,000 metric tons of magnet-bearing products annually, creating a new domestic source of rare earth elements and copper, aluminum and steel for direct reintegration into U.S. manufacturing Cyclic Materials announced today the opening of its first commercial-scale rare earth magnet recycling facility in Mesa, Arizona, marking a major milestone in building domestic supply of rare earths and critical minerals. With an annual processing capacity of up to 25,000 metric tons of magnet-bearing end-of-life products, the facility produces Cyclic’s rare earth magnet material, Mag-Xtract™, and critical minerals such as copper and aluminum, and steel. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260909142592/en/ Leaders gather to mark the opening of Cyclic Materials’ new facility in Mesa, Arizona. From left to right: Herbert Flores, Arizona C
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