1-Laser and 2-Laser 6-Color TBNK Reagents from Cytek® Biosciences Approved for Clinical Use in China
2024年5月29日 - 6:30AM
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 StatementsThis
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
OlsenLages & Associates(949) 453-8080stephanie@lages.com
Investor Contact:Paul
GoodsonHead of Investor RelationsCytek
Biosciencespgoodson@cytekbio.com
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