Fluidigm Corporation (Nasdaq:FLDM), an innovative
biotechnology tools provider with a vision to improve life through
comprehensive health insight, today announced execution of a letter
contract with the National Institutes of Health, National Institute
of Biomedical Imaging and Bioengineering, for a proposed project
under the agency’s Rapid Acceleration of Diagnostics (RADx)
program. The project, with a total proposed budget of up to $37
million, contemplates expanding production capacity and throughput
capabilities for COVID-19 testing with Fluidigm® microfluidics
technology. The letter contract provides Fluidigm with access to up
to $12 million of initial funding based on completion and delivery
of certain validation milestones prior to execution of the
definitive contract.
The RADx program 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.
“This is an exciting milestone,” said Bruce Tromberg, PhD,
Director of the National Institute of Biomedical Imaging and
Bioengineering and leader of RADx Tech, one of four components of
the NIH Rapid Acceleration of Diagnostics initiative. “It will help
increase U.S. testing capacity exponentially. Game-changing
technologies emerging from our RADx pipeline will inform public
health measures to stop the spread of the virus and leave us
better-equipped to address future pathogens and other
diseases.”
A goal of the RADx initiative is to enable approximately 6
million daily tests in the United States by December 2020, many
times the current daily testing rate. The Fluidigm project
targets a production capacity of more than one million COVID-19
tests per day by the end of the first quarter of 2021. Actual
production volumes may vary based on market demand and other
factors.
“The NIH, the National Institute of Biomedical Imaging and
Bioengineering and their partner agencies have moved with lightning
speed to identify and support the technologies best-equipped to
deliver millions of additional COVID-19 tests,” said Chris
Linthwaite, Fluidigm President and CEO. “Fluidigm is proud to be
among the very first companies to be chosen for an award in the
rigorous RADx selection process.
“RADx was established in just five days following the
announcement of $1.5 billion in federal stimulus funding, and the
swift, focused and results-driven approach to executing on the
initiative’s mission is precisely what is needed for everyone to
safely return to public spaces, including work and school.
“Fluidigm technology is well-suited to help expand U.S. COVID-19
testing capacity, and we are gratified for the opportunity to
partner with the NIH on this historic undertaking.”
The letter contract provides access to up to $12 million of the
total proposed funding for the project prior to contract
definitization. Release of funding under the letter contract will
be based on achievement of milestones, which include an initial
validation assessment followed by deliverables related to
development of Fluidigm microfluidics technology and expansion of
related manufacturing capacity.
As of July 30, 640 applications for RADx support had been
submitted, with seven projects, including Fluidigm, advancing in
the current round of contracts to the final, Phase 2 segment of the
RADx selection process. Phase 2 includes completing the validation,
approval and production processes in order to deliver a viable
product in a scaled-up capacity to the U.S. public.
This project is supported by the NIH Rapid Acceleration of
Diagnostics program 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.
About FluidigmFluidigm (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, and plant and animal research
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, Biomark, and CyTOF are
trademarks and/or registered trademarks of Fluidigm
Corporation in the United States and/or other
countries.
Forward-Looking Statements for FluidigmThis
press release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995,
including, among others, statements regarding the total potential
funding for Fluidigm under the RADx project, the completion of a
definitive contract relating to the project, the goals of the
project for production capacity and increases in COVID-19 testing
availability, and expectations regarding the contracting process
for such project. 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 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 changes in the priorities of government agencies;
potential limitations of any Emergency Use Authorization;
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.
Available InformationWe 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 6621mark.spearman@fluidigm.com
Investors: Agnes Lee Vice President, Investor Relations 650 416
7423agnes.lee@fluidigm.com
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