Fluidigm Corporation (Nasdaq:FLDM), an innovative
biotechnology tools provider with a vision to improve life through
comprehensive health insight, today announced that Gnome
Diagnostics, LLC (GnomeDX), a leading pharmacogenomics testing
company, is utilizing Fluidigm® microfluidics technology
and reagents in a test developed to detect the SARS‑CoV‑2 virus,
which causes COVID-19.
The Rapid Turnaround Real-Time RT-PCR™ COVID-19
Test, which can be performed via oropharyngeal, nasopharyngeal and
nasal swab, is intended to meet growing testing needs for patients,
health care workers and other critical populations across central
Ohio. GnomeDX has filed for Emergency Use Authorization (EUA) for
its extraction-free GnomeDX RT-PCR COVID-19 Test from the U.S.
Food and Drug Administration (FDA).
“Supporting our first responders and their patients
are among key goals of our test development program,” said Vicky
Amann, Vice President for Lab Operations at GnomeDx. “Our CLIA
certified genomics lab is ideally suited to this challenge, and we
are committed to support our community in any way we can to respond
to the pandemic.”
“GnomeDX selected the Fluidigm integrated fluidic
circuit technology, reagents and workflow because they provide
high-performance sample throughput that is unmatched by microwell
plate-based PCR assays for the SARS-CoV-2 virus,” Amann added.
GnomeDX is a high-complexity lab certified under
the Clinical Laboratory Improvement Amendments (CLIA) in the
United States and eligible under FDA guidance to create
its own diagnostic tests for COVID-19. GnomeDX has validated a
workflow using assays developed by the Centers for Disease Control
and Prevention designed to be run on the Fluidigm Biomark™ HD
system.
Because sample collection methods for the test
include oropharyngeal and nasal swabs, it does not require invasive
nasopharyngeal collection.
COVID-19 testing on the Biomark HD platform
provides throughput and cost advantages that reduce the impact of
capacity‑constrained supply chains. Fluidigm’s microfluidics
technology enables processing of more samples per batch and uses a
fraction of expensive testing reagents per sample as compared to
more traditional, microwell plate-based PCR technology.
“We believe a significant increase in testing
capacity remains critical to an effective global response to the
COVID-19 crisis,” said Chris Linthwaite, President and CEO of
Fluidigm. “As governments, medical institutions and private labs
look for solutions, speed, scale and automation are paramount.
Since the beginning of the pandemic, we have been supporting labs
around the world as they build out testing infrastructure that
meets these important criteria.
“The Biomark HD platform can generate as many as
6,000 test results per day on a single instrument. More and more
labs are adopting the Fluidigm model of COVID-19 testing, which
offers much-needed high-throughput capability per system. We also
support multiple approaches to sample collection, having recently
filed for Emergency Use Authorization from the FDA for an
extraction-free saliva-based test to detect COVID-19.
“We are honored to have been chosen by GnomeDX to
provide a platform for its COVID-19 test to provide critically
needed testing capacity in central Ohio.”
In early June, Fluidigm filed for Emergency Use
Authorization with the FDA for an extraction-free saliva-based
test to detect the SARS‑CoV‑2 virus. The test 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.
With respect to the Fluidigm test, Fluidigm has
filed for Emergency Use Authorization with the FDA. The test has
been validated by Fluidigm, but the FDA’s independent review of
this validation is pending. The FDA may require additional data,
validation and/or testing, and may not ultimately provide
authorization for EUA requests. An EUA, if granted, does not
constitute FDA clearance or approval, but would allow use by
authorized laboratories only while the EUA is in effect.
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, 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. All other trademarks are the sole property of their
respective owners. Fluidigm products are provided for Research Use
Only. Not for use in diagnostic procedures.
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.
About Gnome
Diagnostics: GnomeDX is a personalized medicine
genetic testing company. Its pharmacogenomic tests help physicians
to prescribe the safest and most effective doses of therapeutics
based on an individual's unique genetic profile. GnomeDX panel
tests can also screen for inherited cardiovascular disease risk,
promoting early detection and prevention. GnomeDX’s goal is to
improve the treatment outcomes for patients, minimize risk and side
effects from prescription drugs, and help reduce the overall cost
of health care. The GnomeDX Diagnostics testing unit intends to
provide COVID-19 assays for safer workplaces and communities under
the guidance of health care professionals. The GnomeDX Science unit
provides molecular lab services for research and pharmaceutical
drug development.
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 potential implementation of Fluidigm microfluidics technology
and products for COVID-19 testing and the anticipated features and
benefits of, and applications and demand for, such products.
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; our
ability and/or the ability of the 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 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.
Contacts
Gnome Diagnostics, LLC
Paige Vandiver VP, Operations 614 431
6414paige@gnomedx.com
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
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