Fluidigm Corporation (Nasdaq:FLDM), an innovative
biotechnology tools provider with a vision to improve life through
comprehensive health insight, today announced a program to expand
availability of Fluidigm® COVID-19 tests for U.S. colleges and
universities. The Fluidigm COVID-19 Campus Safeguard Program will
provide millions of noninvasive, saliva-based tests for the
SARS-CoV-2 virus to qualifying institutions at a cost as low as $5
per test.
The Advanta™ Dx SARS-CoV-2 RT-PCR Assay on
the high-throughput Fluidigm Biomark™ HD system features an
integrated testing platform and a reliable supply chain and can be
easily combined with commonly available automation platforms.
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 SARSCoV2 virus. The assay does not
require collection via invasive nasopharyngeal swab. The company’s
submission to the FDA demonstrated 100 percent agreement between
saliva results from the Advanta Dx SARS-CoV-2 RT-PCR Assay and
results from paired nasopharyngeal samples tested with authorized
assays.
Development, commercialization and implementation of the Advanta
Dx SARS-CoV-2 RT-PCR Assay are supported by a $34 million
definitive contract with the National Institutes of Health under
the agency’s Rapid Acceleration of Diagnostics (RADx) initiative.
The RADx initiative fast-tracks development and commercialization
of innovative technologies to significantly
increase U.S. testing capacity for SARS-CoV-2.
With the scale-up support, the low-cost, saliva-based Advanta
Assay will be targeted to all universities and colleges across the
United States. Many higher education systems are struggling to
deploy affordable testing programs to serve large populations.
Fluidigm has a large number of Biomark HD placements in academic
clinical laboratories in the United States that meet requirements
to perform high-complexity tests in significant numbers.
Many pioneering higher education institutions and labs across
the United States, including the University of Pennsylvania,
Washington University in St. Louis, OU Medicine,
the University of Oklahoma and the Oklahoma Medical
Research Foundation (OMRF), have chosen to use
Fluidigm microfluidics technology and reagents to test
individuals for the SARSCoV2 virus.
“Fluidigm microfluidics enables a tool for testing in a rapid
and affordable format,” said Joel Guthridge, PhD, Director,
Translational Informatics & Clinical Research Resources at
OMRF. “This approach allows us to identify positive individuals and
quickly assess potential exposures and risk with the goal of
keeping our employees and students and their families safer.”
“There are many reasons why high-throughput, saliva-based PCR
testing for SARS-CoV-2 virus detection is a powerful tool for
colleges and universities,” said Chris Linthwaite, Fluidigm
President and CEO. “Fluidigm’s saliva-based PCR test combines an
affordable, kitted solution with sample collection that is far
easier as compared to invasive swabs, and often preferable for both
the health care providers collecting samples and the students and
staff being tested. Our test has demonstrated 100 percent agreement
with paired samples from authorized nasopharyngeal assays. While
antigen testing can be an important element of pandemic response,
it is not enough, as PCR virus detection provides greater
sensitivity.
“Furthermore, the Fluidigm test avoids supply chain constraints
associated with other tests and has received Emergency Use
Authorization from the FDA.
“We are grateful for the support of the NIH RADx initiative,
which has enabled us to accelerate our production capacity and make
the Fluidigm COVID-19 Campus Safeguard Program possible. We will
continue to ramp up our capacity, and in the fourth quarter we
expect to have six million tests available,” Linthwaite said. “We
are excited for this opportunity to play a major role in helping to
keep students and staff safe as our nation continues to navigate
the global health crisis.”
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.
Purchases under the Fluidigm COVID-19 Campus Safeguard Program
are subject to standard terms and conditions, for U.S. colleges and
universities, only while supplies last.
Learn More:
https://go.fluidigm.com/campus-admin
https://go.fluidigm.com/back-to-school
Intended UseAdvanta 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 SARS-CoV-2 in saliva
specimens collected without preservatives in a sterile container
from individuals suspected of COVID-19 by their health care
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 positive 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.
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.
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 the use of Fluidigm’s
Advanta COVID-19 assays by U.S. higher education institutions and
manufacturing capacity, including the number of tests Fluidigm
expects to make available in the fourth quarter of 2020.
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 SpearmanSenior Director, Corporate Communications650
243 6621mark.spearman@fluidigm.com
Investors:Agnes LeeVice President, Investor Relations650 416
7423agnes.lee@fluidigm.com
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