STEMCELL-TECHNOLOGIES
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
Celltrion receives positive CHMP Opinion for SteQeyma™ (ustekinumab biosimilar) autoinjector18.12.2025 03:41:00 CET | Press release
SteQeyma™45mg and 90mg solution for injection via autoinjector (pre-filled pen) receives positive CHMP opinion, which will facilitate subcutaneous administration in patients with plaque psoriasis, psoriatic arthritis (PsA) and Crohn’s disease (CD)1The new autoinjector option increases convenience, enhances individual patient experience and expands administration options Celltrion, Inc. today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion of autoinjector of SteQeyma™, a biosimilar to Stelara® (ustekinumab), for the treatment of plaque psoriasis, psoriatic arthritis (PsA) and Crohn’s disease (CD). The positive CHMP opinion is for SteQeyma autoinjector in 45mg/0.5mL and 90mg/1mL, expanding the currently approved SteQeyma™ presentation, which includes 45mg/0.5mL, 90mg/1mL in a pre-filled syringe and 45mg/0.5mL in a vial for subcutaneous injection, as well as 130mg/26mL concentrate for solution f
Megaport Expands into India, Accelerating Global Growth with Extreme IX Acquisition18.12.2025 02:15:00 CET | Press release
Through the Extreme Exchange (IX) acquisition, Megaport gains seven Internet Exchanges and access to 40+ data centres across India’s fastest-growing digital hubs. Megaport Limited (ASX: MP1) (“Megaport”), the world’s leading Network as a Service (NaaS) provider, today announced the acquisition of Extreme IX,India’s leading Internet Exchange operator, from Extreme Labs, a Bulgaria-headquartered software and network engineering company that incubated the Extreme IX platform. The acquisition expands Megaport’s global platform into one of the world’s fastest-growing digital infrastructure markets and supports the Company’s strategy to deliver scalable, high-performance connectivity services across APAC. The acquisition establishes Megaport’s presence across seven Internet Exchanges in major Indian metros: Delhi, Kolkata, Hyderabad, Chennai, Bengaluru, Mumbai, and Pune, connecting 40+ data centres and more than 400 customers. It also accelerates Megaport’s planned market entry by nearly thr
IonQ and QuantumBasel Expand Long-Term Partnership in Next-Generation Quantum Systems17.12.2025 22:10:00 CET | Press release
Extension solidifies QuantumBasel as IonQ’s Innovation Center in Europe; adds IonQ Tempo and next-generation system to advance quantum commercialization IonQ (NYSE: IONQ), the world’s leading quantum company, today announced an expanded agreement with QuantumBasel, the quantum initiative of uptownBasel, Switzerland’s innovation campus. The extended contract grants QuantumBasel ownership of its existing IonQ Forte Enterprise system and secures ownership of a next-generation Tempo system. This new agreement brings the total deal value of the QuantumBasel and IonQ partnership to over $60 million and extends IonQ’s on-site presence in Switzerland four more years, continuing through 2029. QuantumBasel is IonQ’s official Innovation Center in Europe, serving as a hub for European industry, academia, and research institutions to explore practical quantum computing applications and access IonQ’s latest enterprise-grade systems. “Our extended partnership with QuantumBasel represents a cornerston
Suzano Starts Up New Production Line, Boosting Its Fluff Pulp Capacity by 400%17.12.2025 21:50:00 CET | Press release
A R$490 million investment expands the supply of raw material used in the production of absorbent items Suzano, the world’s largest pulp producer, has commenced operations this week at its new fluff pulp production line located in its Limeira unit in Brazil’s São Paulo state. This R$490 million investment increases Suzano’s total fluff pulp production capacity by more than 400%, from 100,000 to 440,000 tonnes per year. The project involved converting the existing pulp line at the Limeira unit into a flexible machine, capable of producing both Eucafluff® and market pulp. Eucafluff® is used in the production of absorbent and personal hygiene products, such as baby and adult diapers, sanitary pads and pet pads. Then market pulp is supplied for making products including toilet paper, printing and writing papers, and paper packaging. Launched in 2015, Eucafluff® is the world’s first fluff pulp made from eucalyptus, delivering unique advantages like enhanced softness and flexibility, which t
SES Acknowledges Moody’s Rating Action and Reiterates Deleveraging Commitments17.12.2025 21:36:00 CET | Press release
SES S.A. (“SES” or the “Company”), a leading space solutions company, acknowledges the credit rating action announced by Moody’s Investor Service today, which follows the release of SES’ Q3 2025 results and Intelsat integration update. SES management reiterates that the Company continues to execute on its strategy with a clear plan to strengthen its key credit metrics over time. Consistent with this plan, it remains management’s intention to de-lever and return to credit metrics that are commensurate with investment grade, with a policy objective of reducing adjusted net leverage1 to at least 3.0x or below. Today’s rating action does not change the Company’s ability to operate its business, serve customers, or execute its strategic plan. SES maintains a balanced weighted average debt maturity profile of approximately five years, and the rating action from Moody’s is not expected to have a material impact on the interest payable under the Company’s existing debt facilities. SES also ben
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