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Reagents from Cytek Biosciences Granted Approval for Clinical Use in China


Company Makes Complete Spectral Flow Cytometry Solution Available to the Chinese Market

FREMONT, Calif., December 17, 2019 – From instruments to reagents, China-based clinical flow cytometry laboratories now have one destination for all of their spectral flow cytometry needs. Cytek Biosciences Inc., a leading provider of flow cytometry instrumentation, has received approval from the China National Medical Products Administration (NMPA) for its Class I IVD flow cytometry reagents. All 7 of Cytek’s reagents have been cleared for clinical diagnostic use in hospitals, laboratories and clinics across China. This achievement follows the Cytek Northern Lights spectral flow cytometer having been granted clinical approval by the NMPA, enabling Cytek to offer a complete system application solution to the Chinese flow cytometry market.

Used to stain cells for analysis, reagents are critical to the operation of flow cytometers. Cytek’s initial family of reagents consists of basic T, B and NK cell CD markers used for lymphocyte subset detection.

As one of the most widely used flow cytometry clinical applications, lymphocyte subset detection is a common test that is carried out in many clinical laboratories. The results are proven to have unique clinical significance and value in the diagnosis and treatment of many diseases – such as immunodeficiency diseases, autoimmune diseases, tumors, viral infections, and others. The basic detecting cluster of differentiation (CD) markers for lymphocyte subsets are CD3, CD4, CD8, CD16+56, CD19, and CD45 – all of which are available as reagents from Cytek.

“Being granted NMPA clearance is no simple task, and is a testament to our continued commitment to pushing the field of flow cytometry forward,” noted Dr. Wenbin Jiang, CEO of Cytek Biosciences. “Having passed all of China’s regulatory requirements, we will move on to obtain clinical approval in other countries worldwide. We will not rest until we make the benefits of massively multiparametric flow cytometry accessible to a larger number of researchers.”

Please visit www.cytekbio.com for more information.

About Cytek Biosciences Inc.

Cytek Biosciences Inc. is a leading flow cytometry solution provider that develops compact, affordable instruments with high multiplexing capability and a wide range of services to support scientists and clinicians. Cytek is headquartered in Fremont, California with branch offices and distribution channels across the globe. More information about the company and its products is available at www.cytekbio.com. To learn more, follow Cytek on LinkedIn, Twitter and Facebook.