Fluidigm Corporation (Nasdaq:FLDM), an innovative
biotechnology tools provider with a vision to improve life through
comprehensive health insight, today announced COVID-19 Community
Connect, a program to link federal, state and local governmental
entities, public health agencies, academic institutions,
workforces, individuals and a network of high-complexity labs to
deliver saliva-based COVID-19 testing.
As demand for noninvasive saliva-based COVID-19 testing
increases, Fluidigm is serving as a hub to connect interested
communities with testing providers.
“Since announcing our Emergency Use Authorization for
saliva-based PCR testing in late August, we have seen tremendous
interest in our testing technology,” said Chris Linthwaite,
Fluidigm President and CEO. “We created the Community Connect
program to organize a system for assessing needs, recruiting lab
partners and building a service ecosystem for delivering timely
results. This model is proving to be an effective and scalable way
to get the greatest number of our saliva-based COVID-19 tests to
critical populations in communities across the United States.
“We have seen healthy adoption and growing demand for
saliva-based testing with strong new instrument placements in
clinical labs and public health and academic medical centers,”
continued Linthwaite. “With many of the inquiries we receive, the
community seeking our saliva test does not have access to
appropriate lab facilities. To address this need, we developed the
Community Connect program to match demand with testing supply. One
example of this partnership model is an award to a partner testing
lab for testing services around the federal surge testing effort
under the U.S. Department of Health and Human Services
Community-Based Testing Site program.
“We have been building a network of partner labs for a number of
weeks, and we welcome additional partners as well as general
inquiries from groups seeking reliable, cost-effective and
easy-to-administer tests.”
In late August, Fluidigm received Emergency Use Authorization
from the U.S. Food and Drug Administration 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
clinical study submitted to the FDA demonstrated 100 percent
agreement between saliva results from the Advanta assay and results
from paired nasopharyngeal samples tested with authorized
assays.
As an example of the types of connections Fluidigm is creating,
Phase2 Labs of Nashville, Tennessee, has adopted the Advanta assay
to market COVID-19 testing services to corporate and governmental
entities, nursing facilities and on-location film crews.
“Phase2 is honored to collaborate with Fluidigm and other
trusted partners to provide critically needed testing capacity to a
range of organizations relying on COVID-19 tests to make strategic
decisions about safety,” said Steven E. Kress, co-founder and CEO
of Phase2 Labs.
“The saliva-based approach offers a simple, accurate, pain-free
option for PCR COVID-19 testing, and Phase2 can deliver results
within 24 to 48 hours. Based in Nashville, we’re within close reach
of half the U.S. population, enabling us to be vital community
partners in making a meaningful difference in this health
crisis.”
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 that CLIA
laboratories can combine with commonly available automation
platforms.
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.
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.
Learn more about COVID-19 Community Connect:
go.fluidigm.com/community-connect
Intended Use The 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 SARS-CoV-2 in
saliva specimens collected without preservatives in a sterile
container from individuals suspected of COVID-19 by their health
care providers. Testing is limited to 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. 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.
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.
About Phase2 LabsPhase2 Labs, based in
Nashville, Tenn., is the nation’s first commercial molecular
laboratory dedicated to the diagnostic management of acute and
chronic respiratory diseases including COVID-19, ARDS, Chronic
Obstructive Pulmonary Disease (COPD), moderate to severe asthma,
interstitial lung disease, and cystic fibrosis. We employ our
expertise in respiratory pathology to provide testing and
measurement services for SARS-CoV-2. By taking a proactive approach
to the research and analysis of COVID-19, we are building toward
higher quality and better services for those who suffer long-term
respiratory concerns. This further equips us in the contemporary
research for the development of new pharmaceutical products. For
more information, visit: www.phase2laboratories.com
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 potential impact of a
Fluidigm program on U.S. COVID-19 testing availability and
distribution of Fluidigm’s Advanta Dx SARS-CoV-2 RT-PCR Assay.
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 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 6621
mark.spearman@fluidigm.com
Investors:Agnes LeeVice President, Investor Relations650 416
7423
agnes.lee@fluidigm.com
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