PLT and Fluidigm Collaborate on Submission to the National Medical Products Administration for a CyTOF Device Approved for Diagnostic Use in China
South San Francisco, CA (GLOBE NEWSWIRE) - Fluidigm Corporation (NASDAQ:FLDM), an innovative biotechnology tools provider with a vision to improve life through comprehensive health insight, today announced a supply and distribution agreement with Zhejiang PuLuoTing Health Technology Co. Ltd (PLT Tech) to market Fluidigm® CyTOF® technology, panels and reagents to clinical labs in China.
As part of the agreement, the companies are collaborating to seek National Medical Products Administration (NMPA) approval for a CyTOF instrument authorized for diagnostic use in China. NMPA is responsible for the regulation of medical devices and drugs in China.
“We have seen increasing customer demand for CyTOF analysis in recent years from academic and medical centers engaged in translational research. We are excited for the opportunity to work with Fluidigm toward a CyTOF instrument that is approved for clinical use in China,” said Hongyu Shi, PLT Tech CEO. “As part of the development plan, we intend to acquire three CyTOF instruments over the next two years. Our initial focus will be panel development focused on blood cancer diagnostics, particularly those affecting children, and on prognostic evaluation of immunotherapy.”
PLT Tech is a contract research organization offering a range of services including CyTOF analysis throughout China.
“We are excited to partner with PLT on the journey to create a new diagnostics subsegment market in China, ultimately developing prognostic applications to evaluate effectiveness of an ever-growing list of immunotherapy treatments,” said Chris Linthwaite, Fluidigm President and CEO. “According to company and third-party estimates, the addressable market for flow cytometry analysis in blood cancer in China is approximately $100 million for 2021–2023, and is growing at a double-digit rate.”
Fluidigm (Nasdaq:FLDM) focuses on the most pressing needs in translational and clinical research, including cancer, immunology, and immunotherapy. Using proprietary CyTOF and microfluidics technologies, we develop, manufacture, and market multi-omic solutions to drive meaningful insights in health and disease, identify biomarkers to inform decisions, and accelerate the development of more effective therapies. Our customers are leading academic, government, pharmaceutical, biotechnology, plant and animal research, and clinical laboratories worldwide. Together with them, we strive to increase the quality of life for all. For more information, visit fluidigm.com.
Fluidigm, the Fluidigm logo, and CyTOF are trademarks and/or registered trademarks of Fluidigm Corporation in the United States and/or other countries. All other trademarks are the sole property of their respective owners. For Research Use Only. Not for use in diagnostic procedures.
Zhejiang PuLuoTing Health Technology Co. Ltd
Zhejiang PuLuoTing Health Technology Co. Ltd (PLT Tech) is a high-tech company providing single-cell research solutions. Using CyTOF technology and bioinformatics platforms, PLT Tech provides comprehensive services to deliver new insights in immune system and disease, leading development of innovative strategies for disease intervention and health management.
Forward-Looking Statements for Fluidigm
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, among others, statements regarding expectations for a collaboration to seek regulatory approval for CyTOF technology in China, applications for and anticipated sales of CyTOF technology, and market size and growth prospects for flow cytometry in China. Forward-looking statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from currently anticipated results, including but not limited to risks relating to the possible loss of key employees, customers, or suppliers; uncertainties in contractual relationships; challenges inherent in developing, manufacturing, launching, marketing, and selling new products; risks relating to company research and development and distribution plans and capabilities; interruptions or delays in the supply of components or materials for, or manufacturing of, Fluidigm products; potential product performance and quality issues; intellectual property risks; competition; and reductions in research and development spending or changes in budget priorities by customers. Information on these and additional risks and uncertainties and other information affecting Fluidigm business and operating results is contained in Fluidigm’s Annual Report on Form 10-K for the year ended December 31, 2019, and in its other filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof. Fluidigm disclaims any obligation to update these forward-looking statements except as may be required by law.
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