Fluidigm Corporation (Nasdaq:FLDM), an innovative
biotechnology tools provider with a vision to improve life through
comprehensive health insight, today announced it has filed for
Emergency Use Authorization (EUA) from the U.S. Food and Drug
Administration (FDA) for an extraction-free saliva-based test to
detect the SARS‑CoV‑2 virus. The test, developed in collaboration
with scientists at the McDonnell Genome Institute and the
Department of Genetics at Washington University School of Medicine
in St. Louis, provides an easy-to-administer protocol that does not
require collection via invasive nasopharyngeal swab and is
processed on the Biomark™ HD microfluidics platform.
The Advanta™ Dx SARS-CoV-2 RT-PCR Assay is intended for use by
high‑complexity labs certified under the Clinical Laboratory
Improvement Amendments in the United States. The test would enable
health care providers to conduct testing through collection of
saliva, which is significantly easier than invasive nasopharyngeal
swab collection and could enhance testing coverage in critical
populations.
“Rapid, reliable testing that is widely available to the public
is essential in combatting the COVID-19 pandemic,” said Jeffrey
Milbrandt, MD, PhD, Executive Director of the McDonnell Genome
Institute and head of the Department of Genetics at Washington
University School of Medicine. “The close collaboration between
teams at Washington University and Fluidigm aided our efforts to
quickly develop this high-throughput assay for SARS-CoV-2 that
relies on a saliva sample. Such a test could help overcome supply
chain bottlenecks that have limited testing for COVID-19 and help
identify infections.”
The Advanta Dx SARS-CoV-2 RT-PCR test on the Biomark HD platform
provides throughput and cost advantages that reduce the impact of
capacity‑constrained supply chains. The company’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.
“There’s an urgent need to simplify testing for COVID-19 so that
people who are infected can be easily and quickly identified,” said
Richard Head, Director of the Genome Technology Access Center at
the McDonnell Genome Institute. “The test we developed in
collaboration with Fluidigm doesn’t require RNA extraction, a
time-consuming and expensive step necessary to other tests for
SARS-CoV-2. Our test could be easily scaled up and made widely
available.”
Fluidigm will provide updates with regard to timing of broad
commercial availability of the Advanta Dx SARS-CoV-2 RT-PCR
test.
“Our high-throughput saliva-based test enhances testing capacity
and simplifies COVID-19 testing while eliminating the need for
hard-to-source components such as extraction kits,” said Chris
Linthwaite, President and CEO of Fluidigm. “Speed, scale and early
detection have been critically important since the beginning of
this health crisis, and the addition of improvements in ease of use
— eliminating the invasive nasopharyngeal swab protocol without
compromising performance — could make this test a game changer for
the next phase of the global pandemic response.
“The Fluidigm approach bends the cost curve, increases
ultrahigh-throughput testing capability per system, eliminates the
expense and complexity of extraction, and provides a less invasive
sample collection process that could open testing access to large
numbers of people,” Linthwaite said. “We believe frequent
testing of a large percentage of the population is the best path
forward, and a critical foundation for getting the global economy
back to work.
“We are truly honored for the opportunity to collaborate with
Washington University School of Medicine to bring this much-needed
innovation in COVID-19 testing.”
The Advanta Dx SARS-CoV-2 RT-PCR Assay is the subject of an EUA
filing with the FDA. The FDA may require additional data,
validation and/or testing, and may not ultimately provide
authorization. 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 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, 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, Fluidigm products are provided for Research Use
Only. Not for use in diagnostic procedures.
About Washington University School of
MedicineWashington University School of Medicine’s 1,500
faculty physicians also are the medical staff
of Barnes-Jewish and St. Louis
Children’s hospitals. The School of Medicine is a leader in
medical research, teaching and patient care, as is among the top 10
medical schools in the nation as ranked by U.S. News & World
Report. Through its affiliations with Barnes-Jewish and St. Louis
Children’s hospitals, the School of Medicine is linked to BJC
HealthCare.
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 anticipated uses
and features of the Advanta™ Dx SARS-CoV-2 RT-PCR Assay if
Fluidigm’s Emergency Use Authorization is approved by the FDA, its
anticipated commercial availability, and its potential impact on
COVID-19 testing trends, public health, and the economy.
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 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 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 7423 agnes.lee@fluidigm.com
Washington University School of Medicine
Media:Judy Martin FinchDirector, Media
Relations314 750 4213martinju@wustl.edu
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