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Fluidigm Announces Collaboration with Zhejiang PuLuoTing Health Technology Co. Ltd to Market Fluidigm CyTOF Technology to Clinical Labs in China

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Fluidigm Corporation (NASDAQ:FLDM) announced a supply and distribution agreement with Zhejiang PuLuoTing Health Technology Co. Ltd (PLT Tech) to market CyTOF technology in China. The partnership aims for NMPA approval of the CyTOF instrument for diagnostic use, responding to growing demand in clinical settings, particularly for blood cancer diagnostics. The projected addressable market for flow cytometry analysis in this sector is estimated at $100 million from 2021-2023, with a growth rate in the double digits.

Positive
  • Collaboration with PLT Tech aimed at market expansion in China.
  • Potential $100 million addressable market for CyTOF technology in blood cancer diagnostics.
Negative
  • Regulatory approval from NMPA not guaranteed, introducing uncertainty.
  • Market entry and product distribution may face challenges.

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, Calif., Feb. 10, 2021 (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.”

About Fluidigm
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.

Available Information
We use our website (fluidigm.com), investor site (investors.fluidigm.com), corporate Twitter account (@fluidigm), Facebook page (facebook.com/Fluidigm), and LinkedIn page (linkedin.com/company/fluidigm-corporation) as channels of distribution of information about our products, our planned financial and other announcements, our attendance at upcoming investor and industry conferences, and other matters. Such information may be deemed material information, and we may use these channels to comply with our disclosure obligations under Regulation FD. Therefore, investors should monitor our website and our social media accounts in addition to following our press releases, SEC filings, public conference calls, and webcasts.

Fluidigm 

Media:
Mark Spearman
Senior Director, Corporate Communications
650 243 6621
mark.spearman@fluidigm.com

Investors:
Agnes Lee
Vice President, Investor Relations
650 416 7423
agnes.lee@fluidigm.com


FAQ

What is the recent collaboration involving Fluidigm and PLT?

Fluidigm has partnered with PLT Tech to market CyTOF technology and seek NMPA approval for diagnostic use in China.

What is the significance of NMPA approval for Fluidigm?

NMPA approval is crucial for allowing the use of CyTOF instruments in clinical diagnostics in China, potentially expanding Fluidigm's market reach.

How large is the addressable market for Fluidigm's CyTOF technology?

The addressable market for flow cytometry analysis in blood cancer diagnostics in China is estimated to be approximately $100 million for 2021-2023.

What are the potential challenges Fluidigm might face in this collaboration?

Fluidigm may encounter regulatory hurdles, uncertainties in market entry, and product distribution challenges.

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