SOUTH SAN FRANCISCO, Calif., Sept. 08, 2020 (GLOBE NEWSWIRE) -- Fluidigm Corporation (Nasdaq:FLDM), an innovative biotechnology tools provider with a vision to improve life through comprehensive health insight, today announced progress on the Company’s Rapid Acceleration of Diagnostics (RADx) project.
Fluidigm has achieved the initial milestone under its letter contract with the National Institutes of Health, National Institute of Biomedical Imaging and Bioengineering, under the agency’s Rapid Acceleration of Diagnostics (RADx) initiative. The letter contract, which established $12 million of funding available to Fluidigm prior to execution of a definitive contract, provided for initial payment to Fluidigm of approximately $11 million based on achievement of the initial test verification milestone. Fluidigm expects to receive all $12 million in funding associated with the letter contract by the end of the third quarter and is actively engaged in finalizing the definitive contract with the NIH.
The initial milestone involved an independent third-party verification of the Fluidigm® Advanta™ Dx SARS-CoV-2 RT-PCR Assay, which received Emergency Use Authorization from the U.S. Food and Drug Administration in late August. The RADx initiative, whose letter contract with Fluidigm was announced in July, fast-tracks development and commercialization of innovative technologies to significantly increase U.S. testing capacity for SARS-CoV-2, the virus that causes COVID-19. Fluidigm microfluidics technology is the basis for several COVID-19 test assays designed to be run on the Fluidigm Biomark™ HD system.
“Ubiquitous, high frequency testing is essential,” said Chris Linthwaite, President and CEO of Fluidigm. “We believe there are a number of reasons that saliva-based testing will emerge as an ideal method for this type of program. Our test combines accuracy with a simple sample collection approach analyzed on a small, integrated fluidic circuit that runs on a high-throughput PCR platform. In addition, there are emerging needs such as return-to-work and school screening and pan-respiratory panels to differentiate between multiple pathogens. Our platform is ideal for meeting these needs without changing our workflow, instrumentation or software.”
The Fluidigm RADx project is supported by the NIH Rapid Acceleration of Diagnostics initiative and has been funded in whole or in part with federal funds from the National Institute of Biomedical Imaging and Bioengineering, National Institutes of Health, Department of Health and Human Services, under contract no. 75N92020C00009.
Fluidigm’s ongoing collaboration with the Defense Advanced Research Projects Agency (DARPA) and its Epigenetic CHaracterization and Observation (ECHO) program includes financial support for development of innovative programs based on our microfluidics technology.
The Advanta Dx SARS-CoV-2 RT-PCR Assay is for In Vitro Diagnostic Use. It is for Use Under Emergency Use Authorization Only. Rx Only. It has not been FDA cleared or approved. It has been authorized by FDA under an EUA for use by authorized laboratories. It has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. It is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. Other Fluidigm products are For Research Use Only. Not for use in diagnostic procedures.
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, Advanta, Biomark, 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.
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 the benefits and advantages of the Advanta Dx SARS-CoV-2 RT-PCR Assay, including for expansion of COVID-19 testing, customer demand for and commercialization of the Fluidigm test, funding for Fluidigm under the RADx project, and anticipated completion of a RADx definitive contract and associated benefits to Fluidigm. 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 potential adverse effects of the coronavirus pandemic on our business and operating results during 2020; uncertainties in contractual relationships; our ability and/or the ability of the research institutions utilizing our products and technology to obtain and maintain Emergency Use Authorization from the FDA and any other requisite approvals to use our products and technology for diagnostic testing purposes; potential changes in priorities or requirements for Emergency Use Authorizations; potential limitations of any Emergency Use Authorization; potential changes in the priorities of government agencies; 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; and competition. 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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Source: Fluidigm Corporation