1-Laser and 2-Laser 6-Color TBNK Reagents from Cytek® Biosciences Approved for Clinical Use in China
On May 28, 2024, Cytek Biosciences (Nasdaq: CTKB) announced that its 1-laser and 2-laser 6-color TBNK reagent cocktails received approval from China's National Medical Products Administration (NMPA) for clinical use. These reagents, used in the Cytek Northern Lights-Clinical (NL-CLC) cell analysis systems, aid in diagnosing and monitoring immune-related conditions such as immunodeficiencies, autoimmune diseases, infections, and cancers. The NMPA clearance marks the first clinical 1-laser based 6-color TBNK assay supported by Full Spectrum Profiling (FSP) capability. This approval enhances Cytek's market presence in China, offering new opportunities and strengthening its competitive edge. The Cytek NL-CLC systems are designed to perform optimally in multicolor environments, and their onboard volumetric meters reduce testing costs by eliminating the need for counting beads.
- NMPA approval for 1-laser and 2-laser 6-color TBNK reagents in China.
- First clinical 1-laser based 6-color TBNK assay supported by Full Spectrum Profiling (FSP) capability.
- Enhanced market presence in China, opening new opportunities.
- Validated on the Cytek NL-CLC systems for optimal performance.
- Onboard volumetric meters on NL-CLC instruments reduce testing costs.
- Potential regulatory challenges in obtaining approvals in additional geographies.
- Market competition from other cell analysis solutions.
Insights
The recent approval of Cytek Biosciences' 1-laser and 2-laser 6-color TBNK reagent cocktails by the China National Medical Products Administration (NMPA) marks a significant milestone for the company. This regulatory green light allows Cytek to tap into the Chinese market, potentially driving substantial revenue growth. The approval not only validates the safety and efficacy of Cytek's products but also gives the company a competitive edge in a rapidly growing healthcare sector. The use of Full Spectrum Profiling™ (FSP™) capability enhances the functionality of these reagents, raising the bar for clinical diagnostics in China.
From a financial perspective, the expansion into China presents a lucrative opportunity for Cytek, given the vast market size and increasing demand for advanced diagnostic tools. Investors should note that regulatory approvals in additional geographies could further bolster Cytek's revenue streams and market share. However, it is essential to keep an eye on the associated costs of this expansion and any potential delays in achieving further regulatory clearances.
The clinical approval of Cytek's TBNK reagent cocktails in China is a noteworthy development in the field of immunology and clinical diagnostics. These reagents are essential for assessing and monitoring the immune system, playing a critical role in diagnosing and managing conditions like immunodeficiencies, autoimmune diseases, infectious diseases and cancers. The integration of Full Spectrum Profiling™ (FSP™) capability with the 1-laser based 6-color TBNK assay is particularly impressive, as it enables more precise and comprehensive analysis of lymphocyte subsets, which is vital for targeted treatment decisions and patient management.
The use of the Cytek Northern Lights-Clinical (NL-CLC™) system, along with the volumetric meter for absolute cell counts, presents a cost-effective solution by eliminating the need for counting beads. This efficiency gain can lead to broader adoption in hospitals and clinics. Additionally, the approval by NMPA underscores the rigor and reliability of Cytek's products, potentially setting a new standard in clinical diagnostics in China.
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. This is the first clinical 1-laser based 6-color TBNK assay supported by Full Spectrum Profiling™ (FSP™) capability.
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. By providing insight into the immune system's composition, function, and therapeutic response, TBNK reagents support targeted treatment decisions and ongoing patient management.
“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. 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.”
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. Cytek continues to seek regulatory approvals in additional geographies to provide its cell analysis solutions for clinical use more broadly.
About 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’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 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’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, Full Spectrum Profiling, FSP, Cytek Aurora, Northern Lights, NL-CLC, Cytek Orion, Amnis and Guava are trademarks of Cytek Biosciences, Inc.
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. 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.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 as contained in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are subject to the “safe harbor” created by those sections. All statements, other than statements of historical facts, may be forward-looking statements. Forward-looking statements generally can be identified by the use of forward-looking terminology such as “may,” “might," "will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negatives of these terms or variations of them or similar terminology, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements include statements regarding Cytek’s business, product plans and strategies, including its mission to continually expand and enhance its reach and capabilities; Cytek’s business and market opportunities; and Cytek’s plan to continue to seek regulatory approvals in additional geographies to provide its cell analysis solutions for clinical use more broadly. These statements are based on management’s current expectations, forecasts, beliefs, assumptions and information currently available to management. These statements also deal with future events and involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. Factors that could cause actual results to differ materially include risks and uncertainties such as those relating to global economic and market conditions; changes in the regulatory environment; Cytek's ability to obtain and maintain regulatory approvals for its products; competition; market acceptance of Cytek’s current and potential products; Cytek’s dependence on certain sole and single source suppliers; Cytek’s ability to manage the growth and complexity of its organization; Cytek’s ability to manage relationships with key customers and suppliers; Cytek’s ability to retain key employees; and Cytek’s ability to continue to stay in compliance with its material contractual obligations, applicable laws and regulations. You should refer to the section entitled “Risk Factors” set forth in Cytek’s most recent Quarterly Report on Form 10-Q filed with the SEC and other filings Cytek Biosciences makes with the SEC from time to time for a discussion of important factors that may cause actual results to differ materially from those expressed or implied by Cytek’s forward-looking statements. Although Cytek believes that the expectations reflected in the forward-looking statements are reasonable, it cannot provide any assurance that these expectations will prove to be correct nor can it guarantee that the future results, levels of activity, performance and events and circumstances reflected in the forward-looking statements will be achieved or occur. The forward-looking statements in this press release are based on information available to Cytek as of the date hereof, and Cytek disclaims any obligation to update any forward-looking statements provided to reflect any change in its expectations or any change in events, conditions, or circumstances on which any such statement is based, except as required by law. These forward-looking statements should not be relied upon as representing Cytek’s views as of any date subsequent to the date of this press release.
Media Contact:
Stephanie Olsen
Lages & Associates
(949) 453-8080
stephanie@lages.com
Investor Contact:
Paul Goodson
Head of Investor Relations
Cytek Biosciences
pgoodson@cytekbio.com
FAQ
What was announced regarding CTKB's TBNK reagents on May 28, 2024?
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