Fluidigm Corporation (Nasdaq:FLDM), an innovative
biotechnology tools provider with a vision to improve life through
comprehensive health insight, today announced that George
Mason University in Fairfax, Va., is providing saliva-based
COVID-19 testing using the Advanta™ Dx SARS-CoV-2 RT-PCR Assay on
the Fluidigm® Biomark™ HD system.
As part of an expansion of testing capacity for GMU students and
employees, the university purchased two Biomark HD systems and has
equipped labs on the university’s Science and Technology Campus in
Manassas, Va., to process the Advanta Dx Assay, with initial plans
to run approximately 10,000 tests per week.
“Frequent and reliable testing is the core of our plan to keep
students and staff safe at GMU,” said Ali Andalibi, PhD, Professor
and Senior Associate Dean in the College of Science at GMU.
“Adoption of the Advanta Dx SARS-CoV-2 RT-PCR Assay is one element
of a plan to greatly expand our capacity. The noninvasive nature of
the assay, accuracy and time to results are among key advantages of
the Fluidigm system, which we have combined with an automation
platform for testing at scale.
“The testing capacity provided by the Fluidigm system, along
with systematic precautionary measures such as masks and social
distancing, will help us limit the spread of the virus at
Mason.”
Fluidigm 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 in individuals
suspected of COVID-19 by their health care providers. The assay
does not require collection via invasive nasopharyngeal swab, and
the company’s submission to the FDA demonstrated 100 percent
agreement between saliva results from the Advanta Dx Assay and
results from paired nasopharyngeal samples tested with authorized
assays.
A growing body of peer-reviewed research is confirming that the
accuracy of saliva-based COVID-19 testing is comparable to that of
nasopharyngeal-based testing. A systematic review and
meta-analysis published in JAMA Internal Medicine in January
2021 stated that saliva-based tests have a similar sensitivity and
specificity and present an attractive alternative to invasive
nasopharyngeal testing.
“Fluidigm is grateful for the opportunity to enable simple,
affordable and accessible testing to help keep colleges and
universities open and their staffs and students healthy,” said
Chris Linthwaite, Fluidigm President and CEO. “We are
proud of our collaborations with a number of higher education
institutions to provide a test with a sample type that is far
easier to collect than invasive swabs, and that individuals often
prefer from a comfort perspective.”
Fluidigm continually conducts in silico analyses to determine
the effectiveness of the Advanta Dx Assay design to detect
SARS-CoV-2. To date, none of the published viral mutations
meaningfully impact the regions of the viral genome targeted by the
assay’s primers and probes.
Intended UseThe 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
healthcare provider. Testing is limited to Laboratories which are
certified under the Clinical Laboratory Improvement Amendments of
1988 (CLIA), 42 U.S.C. §263a, and meet requirements to perform high
complexity tests.
Results are for the identification of SARS-CoV-2 RNA. The
SARS-CoV-2 RNA is generally detectable in saliva specimens during
the acute phase of infection. Positive results are indicative of
the presence of SARS-CoV-2 RNA; clinical correlation with patient
history and other diagnostic information is necessary to determine
patient infection status. Positive results do not rule out
bacterial infection or co-infection with other viruses. The agent
detected may not be the definite cause of disease. Laboratories
within the United States and its territories are required to report
all results to the appropriate public health authorities.
Negative results do not preclude SARS-CoV-2 infection and should
not be used as the sole basis for patient management decisions.
Negative results must be combined with clinical observations,
patient history, and epidemiological information. Negative results
for SARS-CoV-2 RNA from saliva should be confirmed by testing of an
alternative specimen type if clinically indicated.
The Advanta™ Dx SARS-CoV-2 RT-PCR Assay is intended for use by
qualified and trained clinical laboratory personnel specifically
instructed and trained in the techniques of real-time PCR and in
vitro diagnostic procedures. The Advanta™ Dx SARS-CoV-2 RT-PCR
Assay is only for use under the Food and Drug Administration's
Emergency Use Authorization.
Other Fluidigm products are provided 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.
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.
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 expectations for
specified third parties to conduct COVID-19 testing using the
Advanta Dx SARS-CoV-2 RT-PCR Assay, the benefits of implementing
the Advanta Dx Assay and saliva-based COVID-19 testing, the numbers
of Advanta Dx Assays to be processed by third parties, the benefits
of providing tests to certain communities and customers, and demand
for the Fluidigm tests. 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; the
possible loss of key employees, customers, or suppliers;
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 authorizations or approvals to use
our products and technology for diagnostic testing purposes;
potential changes in priorities or requirements for Emergency Use
Authorizations or other regulatory authorizations or approvals;
potential limitations of any Emergency Use Authorization or other
regulatory authorizations or approvals; 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 SpearmanSenior Director, Corporate Communications650
243 6621
mark.spearman@fluidigm.com
Investors:Agnes LeeVice President, Investor Relations650 416
7423agnes.lee@fluidigm.com
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