Fluidigm Achieves Initial Milestone under NIH Rapid Acceleration of Diagnostics Agreement
September 08 2020 - 8:30AM
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.
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, 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 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 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.
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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