Cytek® Biosciences Receives CE Marking for Series of cFluor® Reagents, TBNK Kit
Company Moves to Make Total Cell Analysis Solutions Available for Clinical Applications in the European Market
FREMONT, Calif., May 24, 2022 (GLOBE NEWSWIRE) -- Clinical flow cytometry laboratories based in Europe can now purchase Cytek cFluor® CE-IVD-certified reagents for their use. Cytek Biosciences, Inc. (Nasdaq: CTKB), a leading cell analysis solutions company, today announced that a series of single-color cFluor reagents and a 6-color TBNK kit have received CE Marking under the European Union In Vitro Diagnostic Medical Devices Directive (IVDD) 98/79/EC. Other regions that accept the CE marking are also included in the certification.
This achievement makes cFluor reagents available for clinical diagnostic use in hospitals, laboratories and clinics across Europe, and positions the company on a path to offering a total cell analysis solution to the European market – from instruments to reagents.
Cytek’s cFluor reagents have been designed, manufactured and tested in accordance with Cytek design controls, quality systems and applicable verification and validation procedures and protocols that are reflective of flow cytometry in vitro diagnostic medical devices. The extensive testing that has been conducted on these reagents has shown that they are capable of performing to their stated intended use and specification requirements.
“CE-IVD certification allows Cytek to enter into new markets for clinical in vitro diagnostics,” noted Dr. Wenbin Jiang, CEO of Cytek Biosciences. “We continue to maintain a deep focus on providing a complete cell analysis solution to our customers – and achieving CE Marking and gaining European market access extends this commitment. Cytek cFluor reagents represent our years of experience understanding full spectrum cytometry and how fluorophores react together in multicolor panels. Using cFluor reagents, scientists and researchers can go even further with our unique, state-of-the-art cell analyzers – and feel confident in doing so.”
Cytek’s cFluor reagents are all validated on the Cytek® Aurora and Cytek® Northern Lights™ cell analysis systems, ensuring optimal performance for users in a multicolor environment. Cytek continues to seek regulatory approvals, targeting additional geographies to ensure that its entire range of cell analysis solutions will be authorized for clinical use in countries worldwide.
For more information about Cytek’s cFluor reagents and kits, please visit https://cytekbio.com/collections/reagents.
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 Aurora and Northern Lights™ systems; its cell sorter, the Aurora CS; and reagents, software and services 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.
Other than Cytek’s Northern Lights CLC system and certain reagents for use therewith, which are available for clinical use in countries where the regulatory approval has been obtained from the local regulatory authorities, including China and the European Union, Cytek’s products are for research use only and not for use in diagnostic procedures. Please contact your local sales representatives for the status of local regulatory approval.
Cytek, cFluor, Full Spectrum Profiling, FSP and Northern Lights are trademarks or registered 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 corporate 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 Twitter account in addition to following its SEC filings, news releases, public conference calls and webcasts.
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 Biosciences’ plans to offer a total cell analysis solution to the European market and to seek additional regulatory approvals targeting additional geographies to ensure that its entire range of cell analysis solutions will be authorized for clinical use in countries worldwide. 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 market conditions; the ongoing COVID-19 pandemic; Cytek Biosciences’ dependence on certain sole and single source suppliers; competition; market acceptance of Cytek Biosciences’ current and potential products; Cytek Biosciences’ ability to manage the growth and complexity of its organization; Cytek Biosciences’ ability to maintain, protect and enhance its intellectual property; and Cytek Biosciences’ 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 Biosciences’ Quarterly Report on Form 10-Q filed with the SEC on May 12, 2022 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 Biosciences’ forward-looking statements. Although Cytek Biosciences 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 Biosciences as of the date hereof, and Cytek Biosciences 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 Biosciences’ views as of any date subsequent to the date of this press release.
Lages & Associates
Head of Investor Relations