Pharma Focus Asia

Cytek® Biosciences Gains Approval for 1-Laser and 2-Laser 6-Color TBNK Reagents for Clinical Use in China

Wednesday, May 29, 2024

Cytek Biosciences, Inc. (Nasdaq: CTKB) has announced that its 1-laser and 2-laser 6-color TBNK reagent cocktails have received approval from the China National Medical Products Administration (NMPA) for clinical diagnostic use on the Cytek® Northern Lights™-Clinical (NL-CLC™) cell analysis systems. This marks the first clinical approval for a 1-laser based 6-color TBNK assay supported by Full Spectrum Profiling™ (FSP™) technology.

TBNK analysis is crucial for evaluating and monitoring the immune system's status in various medical conditions. These reagents allow for the identification and quantification of key lymphocyte subsets, aiding in diagnosing and monitoring immunodeficiencies, autoimmune diseases, infectious diseases, and cancers. By providing insights into the immune system's composition, function, and therapeutic response, TBNK reagents help guide targeted treatment decisions and ongoing patient management.

“We are committed to delivering innovative and powerful solutions that enable clinicians to rapidly and efficiently gain deep insights into patient diagnoses,” said Wenbin Jiang, Ph.D., CEO of Cytek Biosciences. “Obtaining NMPA clearance is a significant milestone that validates the safety and efficacy of our TBNK reagents. This approval strengthens our market presence in China, opens up new opportunities, and enhances our competitive edge.”

The assay is validated on the Cytek Northern Lights-Clinical (NL-CLC) cell analysis systems, ensuring optimal performance in a multicolor environment. Furthermore, the use of an on-board volumetric meter for absolute cell counts on NL-CLC instruments eliminates the need for counting beads, thereby reducing testing costs. Cytek is also seeking regulatory approvals in other regions to expand the clinical availability of its cell analysis solutions.



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