Press Release   -

STEMCELL Technologies Receives FDA De Novo Classification for EasySep™ CD138 Positive Selection Kit

According to analysts at Vantage Market Research, the Global Cancer Stem Cells Market is anticipated to achieve USD 3.72 Billion by 2032 with a CAGR of 12%.

STEMCELL Technologies, a pioneering entity in life sciences research, has achieved a groundbreaking milestone with its latest innovation, the EasySep™ Human Bone Marrow CD138 Positive Selection Kit. This cutting-edge product has been granted de novo classification by the U.S. Food and Drug Administration (FDA), marking it as a first-of-its-kind in vitro diagnostic (IVD) medical device for hematopoietic cell enrichment.

The potential of this achievement is enormous, as it could revolutionize cancer diagnostics, mainly in the field of multiple myeloma, which is a form of cancer impacting plasma cells and accounting for approximately 2% of all cancer instances in the United States. The EasySep™ CD138 Positive Selection Kit enables the enrichment of plasma cells expressing the CD138 marker (CD138+ cells) from patient bone marrow samples. This targeted enrichment enhances the sensitivity of downstream in vitro diagnostic tests, empowering healthcare providers to better assess patient risk & tailor treatment strategies accordingly.

Dr. Allen Eaves, President and CEO of STEMCELL Technologies, expressed pride in this milestone accomplishment, emphasizing the company's dedication to improving patient care and outcomes. "Developing an in vitro diagnostic (IVD) product that enhances the precision of information used to guide the treatment of patients with multiple myeloma represents a significant accomplishment, demonstrating our dedication to positively influencing human health," stated Dr. Eaves.

This FDA classification heralds a new era in cancer diagnostics, as it recognizes the importance of hematopoietic cell enrichment in the pre-analytical workflow. The EasySep™ CD138 Positive Selection Kit fills a critical gap in the diagnostic landscape, providing clinicians with a reliable tool to enhance the sensitivity and resolution of diagnostic assays for multiple myeloma.

STEMCELL Technologies' commitment to further innovation in the IVD field is evident, with plans to expand its diagnostic product portfolio and support industry partnerships through its Diagnostics Partnerships & OEM Solutions Program.

The EasySep™ Human Bone Marrow CD138 Positive Selection Kit represents a culmination of years of rigorous research and development, underpinned by STEMCELL's unwavering dedication to advancing scientific discovery. With its impending availability in key markets including the United States, the European Union, Canada, and the United Kingdom, this innovative solution is poised to make a significant impact in cancer diagnostics and patient care globally.

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