Fluidigm Corporation (Nasdaq:FLDM), an innovative
biotechnology tools provider with a vision to improve life through
comprehensive health insight, today announced it has received
Emergency Use Authorization (EUA) from the U.S. Food and Drug
Administration (FDA) for the Advanta™ Dx SARS-CoV-2 RT-PCR Assay,
an extraction-free saliva-based test to detect nucleic acid from
the SARS‑CoV‑2 virus, designed to be run on the Fluidigm®
Biomark™ HD microfluidics platform.Because it is saliva-based, the
Advanta Dx SARS-CoV-2 RT-PCR Assay does not require collection via
invasive nasopharyngeal swab. The clinical study associated with
the EUA submission demonstrated 100 percent agreement between the
saliva results from the Advanta Dx SARS-CoV-2 RT-PCR Assay and the
results from paired nasopharyngeal samples tested with authorized
assays.
“Accessible and accurate testing programs that include a
non-invasive, saliva-based collection option will be essential
throughout duration of the COVID-19 pandemic”, said Andrew Lukowiak
Ph.D, CEO of San Diego-based Millennium Health, one of several
high-complexity labs certified under the Clinical Laboratory
Improvement Amendments (CLIA) in the United States that has
been evaluating the Advanta Dx SARS-CoV-2 RT-PCR Assay in advance
of authorization.
“In addition to the attractive sample input we chose the
Fluidigm workflow because it combines extraordinary throughput per
system with a robust supply chain from a trusted large-scale
supplier. We believe this approach will enhance testing coverage in
critical populations.”
The Advanta Dx SARS-CoV-2 RT-PCR test on the Biomark HD platform
provides throughput advantages that reduce the impact of
capacity‑constrained supply chains. The company’s microfluidics
technology enables processing of more samples per batch than more
traditional, microwell plate-based PCR technology. The Biomark HD
platform can generate as many as 6,000 test results per day on a
single system. “We have seen extraordinarily strong customer
interest in our high-throughput saliva-based test, including many
new purchases of Biomark HD systems to enable its adoption,” said
Chris Linthwaite, President and CEO of Fluidigm. “We have a high
degree of confidence that this new test will not only enhance
testing capacity but will also significantly improve speed to
results and scale. The ease of use for health care providers and
patients alike will enable improved testing access to the global
population. Fluidigm is excited to commercialize this easily
administered saliva-based COVID-19 test during a critical phase of
the pandemic.
“In the United States, Emergency Use Authorization for our test
coincides with the total number of COVID-19 cases exceeding 5.7
million, underscoring the need for scalable and easy-to-administer
testing.”
Fluidigm was recently selected by 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. RADx fast-tracks
development and commercialization of innovative technologies to
significantly increase U.S. testing capacity for SARS-CoV-2.
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 RADx project envisions both a major expansion of
microfluidics manufacturing capacity and commercialization of a
novel barcoding chemistry to further increase test throughput per
system.
The Advanta Dx SARS-CoV-2 RT-PCR Assay was developed in
collaboration with scientists at the McDonnell Genome Institute and
the Department of Genetics at the Washington University School of
Medicine in St. Louis.
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 RADx project 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.
About Emergency Use Authorization Status
Advanta™ Dx SARS-CoV-2 RT-PCR Assay is a real-time reverse
transcription (RT) PCR test intended for the qualitative detection
of nucleic acid from the SARS-CoV-2 in saliva specimens collected
without preservatives in a sterile container from individuals
suspected of COVID-19 by their health care provider.
This test has not been FDA cleared or approved. It has been
authorized by the FDA under an EUA for use by authorized
laboratories that are certified under the Clinical Laboratory
Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, and meet
requirements to perform high-complexity tests. This test has been
authorized only for the detection of nucleic acid from SARS-CoV-2,
not for any other viruses or pathogens. This test 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.
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, total potential 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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