FREMONT, Calif., May 28, 2024 (GLOBE NEWSWIRE) -- Today Cytek Biosciences, Inc. (Nasdaq: CTKB) announced that its 1-laser and 2-laser 6-color TBNK reagent cocktails have received China National Medical Products Administration (NMPA) approval for clinical diagnostic use on the Cytek® Northern Lights™-Clinical (NL-CLC™) cell analysis systems in hospitals, laboratories and clinics across China.

加利福尼亚州弗里蒙特，2024年5月28日（环球通讯社）——今天，Cytek Biosciences，Inc.（纳斯达克：CTKB）宣布，其1激光和2激光6色TBNK试剂混合物已获得中国国家医疗产品管理局（NMPA）批准，可在中国各地的医院、实验室和诊所的Cytek®Northern Lights™-clinical（NL-CLC™）细胞分析系统上进行临床诊断。

This is the first clinical 1-laser based 6-color TBNK assay supported by Full Spectrum Profiling™ (FSP™) capability..

这是第一个基于临床1激光的6色TBNK分析，由Full Spectrum Profiling™（FSP™）功能支持。。

Clinical TBNK analysis is routinely used to assess and monitor immune system status for various medical conditions, with TBNK reagents enabling the identification and quantification of key lymphocyte subsets. These reagents help in diagnosing and monitoring various immune-related conditions, including immunodeficiencies, autoimmune diseases, infectious diseases and cancers.

临床TBNK分析通常用于评估和监测各种医疗条件下的免疫系统状态，TBNK试剂可以识别和定量关键的淋巴细胞亚群。这些试剂有助于诊断和监测各种免疫相关疾病，包括免疫缺陷，自身免疫性疾病，传染病和癌症。

By providing insight into the immune system's composition, function, and therapeutic response, TBNK reagents support targeted treatment decisions and ongoing patient management..

通过深入了解免疫系统的组成，功能和治疗反应，TBNK试剂支持有针对性的治疗决策和持续的患者管理。。

“Cytek remains dedicated to providing innovative and powerful solutions that allow clinicians to quickly and efficiently gain profound insights into the clinical diagnosis of patients,” said Wenbin Jiang, Ph.D., CEO of Cytek Biosciences. “A crucial element of this mission is to continually expand and enhance our reach and capabilities.

Cytek Biosciences首席执行官姜文斌博士说：“Cytek仍然致力于提供创新而强大的解决方案，使临床医生能够快速有效地深入了解患者的临床诊断。”。“这项任务的一个关键要素是不断扩大和增强我们的影响力和能力。

Obtaining NMPA clearance is a significant milestone, achieved through a rigorous process that validates the safety and efficacy of Cytek’s TBNK reagents. It also enhances our market presence in China and opens up new opportunities – while strengthening our competitive advantage.”.

获得NMPA清除率是一个重要的里程碑，通过严格的过程来验证Cytek TBNK试剂的安全性和有效性。它还增强了我们在中国的市场占有率，并开辟了新的机会，同时增强了我们的竞争优势。”。

This assay is validated on the Cytek Northern Lights-Clinical (NL-CLC) cell analysis systems, which ensures optimal performance for users in the multicolor environment. In addition, the absolute cell counts are determined by using the on-board volumetric meter on NL-CLC instruments instead of counting beads, reducing the cost of the testing.

该测定法已在Cytek Northern Lights Clinical（NL-CLC）细胞分析系统上进行了验证，该系统可确保用户在多色环境中获得最佳性能。此外，绝对细胞计数是通过在NL-CLC仪器上使用车载体积计而不是计数珠子来确定的，从而降低了测试成本。

Cytek continues to seek regulatory approvals in additional geographies to provide its cell analysis solutions for clinical use more broadly. .

Cytek继续在其他地区寻求监管部门的批准，以提供更广泛的临床应用细胞分析解决方案。。

About Cytek Biosciences, Inc.

关于Cytek Biosciences，Inc。

Cytek Biosciences (Nasdaq: CTKB) is a leading cell analysis solutions company advancing the next generation of cell analysis tools by delivering high-resolution, high-content and high-sensitivity cell analysis utilizing its patented Full Spectrum Profiling™ (FSP™) technology. Cytek’s novel approach harnesses the power of information within the entire spectrum of a fluorescent signal to achieve a higher level of multiplexing with precision and sensitivity.

Cytek Biosciences（纳斯达克股票代码：CTKB）是一家领先的细胞分析解决方案公司，通过利用其专利的Full Spectrum Profiling™（FSP™）技术提供高分辨率，高含量和高灵敏度的细胞分析，推进下一代细胞分析工具的发展。Cytek的新方法利用荧光信号整个光谱中的信息能力，以实现更高水平的精确和灵敏度多路复用。

Cytek’s FSP platform includes its core instruments, the Cytek Aurora™ and Northern Lights™ systems; its cell sorter, the Cytek Aurora™ CS; the flow cytometer and imaging products under the Amnis® and Guava® brands; the Cytek Orion™ reagent cocktail preparation system, and reagents, software and services to provide a comprehensive and integrated suite of solutions for its customers.

Cytek的FSP平台包括其核心仪器Cytek Aurora™和Northern Lights™系统；其细胞分选仪Cytek Aurora™CS；Amnis®和Guava®品牌的流式细胞仪和成像产品；Cytek Orion™试剂鸡尾酒制备系统，以及试剂、软件和服务，为客户提供全面集成的解决方案套件。

Cytek headquarters are in Fremont, California with offices and distribution channels across the globe. More information about the company and its products is available at www.cytekbio.com..

Cytek总部位于加利福尼亚州弗里蒙特，在全球设有办事处和分销渠道。有关该公司及其产品的更多信息，请访问www.cytekbio.com。。

Cytek’s products are for research use only and not for use in diagnostic procedures (other than Cytek’s Northern Lights-CLC system and certain reagents, which are available for clinical use in China and the European Union).

Cytek的产品仅用于研究用途，不用于诊断程序（Cytek的Northern Lights CLC系统和某些试剂除外，这些试剂可在中国和欧盟临床使用）。

Cytek, Full Spectrum Profiling, FSP, Cytek Aurora, Northern Lights, NL-CLC, Cytek Orion, Amnis and Guava are trademarks of Cytek Biosciences, Inc.

Cytek、全光谱分析、FSP、Cytek Aurora、Northern Lights、NL-CLC、Cytek Orion、Amnis和Guava是Cytek Biosciences，Inc.的商标。

In addition to filings with the Securities and Exchange Commission (SEC), press releases, public conference calls and webcasts, Cytek uses its website (www.cytekbio.com), LinkedIn page and X (formerly Twitter) account as channels of distribution of information about its company, products, planned financial and other announcements, attendance at upcoming investor and industry conferences and other matters.

除了向美国证券交易委员会（SEC）提交文件、新闻稿、公开电话会议和网络广播外，Cytek还使用其网站（www.cytekbio.com）、LinkedIn页面和X（前Twitter）账户作为传播公司、产品、计划财务和其他公告、出席即将举行的投资者和行业会议以及其他事项的渠道。

Such information may be deemed material information and Cytek may use these channels to comply with its disclosure obligations under Regulation FD. Therefore, investors should monitor Cytek’s website, LinkedIn page, and X account in addition to following its SEC filings, news releases, public conference calls and webcasts..

此类信息可能被视为重大信息，Cytek可能会使用这些渠道来遵守FD法规规定的披露义务。因此，投资者除了关注Cytek的SEC文件、新闻稿、公开电话会议和网络广播外，还应该监控Cytek的网站、LinkedIn页面和X账户。。