Certification Emphasizes Unwavering Commitment to Quality and Is an Essential Step for U.S. Clinical Market Entry
FREMONT, Calif., Aug. 21, 2024 (GLOBE NEWSWIRE) -- Today Cytek Biosciences, Inc. (Nasdaq: CTKB) announced that its San Diego reagent manufacturing facility has been awarded EN ISO 13485:2016 Quality Management System (QMS) certification. This certification encompasses the design, development, manufacturing, and distribution of reagents and accessories, highlighting the company's adherence to rigorous quality standards. Cytek’s manufacturing facilities in Wuxi, China and its headquarters in Fremont, California are also EN ISO 13485:2016 certified.
ISO 13485 is a globally recognized standard that outlines the requirements for a comprehensive QMS specific to the medical device industry. It is crucial that medical devices meet consistent quality and regulatory requirements, which are essential for patient safety and effective healthcare delivery. The standard covers all aspects of a product's lifecycle, from initial design and development through production and distribution, to promote product safety and reliability. ISO 13485 certification also facilitates access to international markets by aligning with various regulatory requirements.
Cytek’s comprehensive suite of reagents are tailored for flow cytometry applications. To harmonize processes and respond swiftly to market demands and technology advancements, Cytek recently moved its reagent manufacturing from its Fremont headquarters to San Diego. The San Diego facility manufactures Cytek’s cFluor®, Guava®, Muse® and Tonbo™ reagents.
"Receiving ISO 13485 certification is a major step in our journey toward making clinical grade reagents readily available and sets the foundation for our continued market expansion," said Chris Williams, chief operating officer for Cytek Biosciences. "This certification is a testament to the hard work and dedication of our team, who have worked tirelessly to meet stringent quality standards. It reassures our customers of our commitment to providing high-quality products. We anticipate that our planned expansion into the clinical market in the U.S. will enhance our service offerings and contribute to our revenue growth.”
The EN ISO 13485:2016 certification was awarded following a thorough assessment and audit of the facility's QMS by TÜV Rheinland®, a leading independent certification body. Currently, Cytek’s products are approved for clinical and diagnostic use in China and the European Union. The achievement of ISO 13485 certification is a crucial step towards Cytek’s entry into the U.S. clinical market.
For more information, please visit www.cytekbio.com.
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 Cytek Orion™ reagent cocktail preparation system; the Enhanced Small Particle (ESP™) detection technology, the flow cytometer and imaging products under the Amnis® and Guava® brands; and reagents, software and service to provide a comprehensive and integrated suite of solutions for its customers. Cytek is headquartered 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, ESP, Cytek Orion, Amnis, Guava, Muse and Tonbo 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, strategies and market opportunities, including Cytek’s plans to expand into the clinical market in the U.S. and the anticipated enhancement of Cytek’s service offerings and future revenue growth. 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 the regulatory approval process; global economic, political and market conditions; 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 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
