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
Speech Processing Solutions Launches Philips SpeechLive Health, an AI Assistant Built for Modern Clinical Documentation17.3.2026 15:00:00 CET | Press release
Philips SpeechLive Health AI Assistant uses healthcare-trained AI to convert clinical conversations into structured notes, helping clinicians reduce administrative burden Speech Processing Solutions, the global leader in professional dictation and speech solutions sold under the Philips brand, today announced the upcoming April 2026 launch of Philips SpeechLive Health AI Assistant, an AI-powered clinical documentation assistant designed for healthcare professionals across multiple care settings. This solution reduces administrative burden, streamlines documentation, and improves provider and patient experiences. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260317743584/en/ Philips SpeechLive Health AI Assistant turns clinical conversations into structured documentation, helping reduce administrative workload and create more time for patient care. Purpose-built for clinical documentation workflows Clinical workload remains
Moody’s Ratings Becomes First Credit Rating Agency to Bring Independent Credit Analysis to Blockchain Financial Infrastructure17.3.2026 15:00:00 CET | Press release
Moody’s Corporation (NYSE: MCO) today announced that Moody’s Ratings has launched its network-agnostic Token Integration Engine™ (TIE), becoming the first credit rating agency to ingest analytical data and share credit insights on-chain. As an inaugural step, it is the first rating agency to operate a node on the Canton Network. The milestone marks a significant step in Moody’s commitment to digital innovation, intending to enable secure, compliant, and efficient ingestion of data and dissemination of ratings enabled by technology built for integration across platforms. “As financial markets digitize, the need for independent, trusted risk analysis and credit insights does not change,” said Fabian Astic, Managing Director and Global Head of Digital Economy at Moody’s Ratings. “Moody’s Ratings is extending that rigor to digital market infrastructure consistent with global regulatory expectations and our governance, transparency, and compliance practices.” Moody’s Ratings’ TIE serves as
Coherent Solutions Releases Research on AI-driven Fraud Prevention in Banking and Finance and the Best AI Models for Banks17.3.2026 15:00:00 CET | Press release
Coherent Solutions has released a Future of Finance research illustrating how AI is advancing fraud detection in financial services. The research offers financial institutions a strategic framework to address rising and more sophisticated fraud techniques with adaptive, human-in-the-loop AI systems, based on the firm’s extensive experience in AI engineering. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260317526196/en/ Coherent Solutions releases research on AI-driven fraud prevention. This white paper addresses the modern threat of transaction fraud, which is becoming faster and smarter while conventional rule-based systems lag, leaving financial institutions exposed. Banks, credit lenders, and financial institutions that adopt AI and machine learning can reduce fraud losses by up to 50% and detect anomalies in real time. When implemented with proper governance and human oversight, AI systems also make audits smoother and
The Swoosh Meets the ‘b’: Beats and Nike Unveil Historic First-Ever Collaboration for Powerbeats Pro 217.3.2026 15:00:00 CET | Press release
LeBron James trades the court for the course in a star-studded campaign celebrating the ultimate performance crossover Today, Beats and Nike announced the first hardware collaboration in their shared history: Powerbeats Pro 2 – Nike Special Edition. In a landmark design shift, Beats has—for the first time—shared its iconic earbud real estate with a partner, featuring the Nike Swoosh on the right bud and the signature Beats “b” on the left. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260317159868/en/ Powerbeats Pro 2 - Nike Special Edition The limited-edition release marries Nike’s high-energy “Volt” color palette with the industry-leading audio tech of the Powerbeats Pro 2. The result is a performance tool built to bridge the gap between elite sport and street style. The Nike Special Edition arrives in a striking matte black, Volt-speckled charging case. Upon opening, users are greeted by Nike’s “JUST DO IT” mantra printe
Sub-Q Bionics Announces Licensing Agreement to Advance Lymphedema Care17.3.2026 14:46:00 CET | Press release
Sub‑Q Bionics, a medical device company developing an innovative implantable lymphatic drainage system designed to help patients living with lymphedema better manage their symptoms, today announced a licensing agreement with Mayo Clinic. Through the agreement, Sub-Q Bionics has licensed clinical know-how from Mayo Clinic related to reconstructive and lymphatic surgery. As part of this collaboration, Vahe Fahradyan, M.D., a plastic and reconstructive surgeon with expertise in lymphatic surgery, plans to work with Sub-Q Bionics as a clinical collaborator supporting the company’s ongoing development activities. Lymphedema is a chronic condition caused by impaired lymphatic drainage that can lead to persistent swelling, discomfort, and reduced mobility. It commonly occurs following cancer treatment, particularly among breast cancer survivors. Sub-Q Bionics is developing the world’s first implantable bionic lymphatic drainage system designed to assist with movement of lymphatic fluid and he
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