Fluidigm Corporation (Nasdaq:FLDM), an innovative
biotechnology tools provider with a vision to improve life through
comprehensive health insight, today announced
that ImmunoGenomics, based in metropolitan Houston, and Vero
Diagnostics of Research Triangle Park, North Carolina, are among
the Clinical Laboratory Improvement Amendments (CLIA) certified
labs now offering testing services using the Advanta™ Dx SARS-CoV-2
RT-PCR Assay on the Fluidigm® Biomark™ HD system.
Fluidigm recently 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. 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 SARS-CoV-2 RT-PCR Assay
and results from paired nasopharyngeal samples tested with
authorized assays.
“As a scientist-owned-and-operated, CLIA-certified lab, we
believe saliva-based testing for COVID-19 via high-throughput PCR
is the gold standard of detection for private, public and
government testing environments,” said Twinkle Patel,
ImmunoGenomics President and CEO. “The Fluidigm workflow enables
high-throughput processing of samples using established methods
certified by the Centers for Disease Control and Prevention and the
World Health Organization. This extraordinary throughput is coupled
with a robust supply chain and a high degree of accuracy.”
ImmunoGenomics currently processes approximately 3,000 samples per
day using the Advanta Dx SARS-CoV-2 RT-PCR Assay.
“The extraction-free nature of the Fluidigm assay is enabling
our lab to eliminate bottlenecks and streamline processing of
samples,” said Ritesh Shah, Managing Partner and Founder of Vero
Diagnostics. “We are processing approximately 3,000 samples per day
for medical centers, skilled nursing facilities, urgent care
clinics and others. Invasive nasopharyngeal swab-based testing is
not sustainable in situations in which regular testing is required.
We believe the saliva-based model is the future of COVID
testing.”
“There are many reasons why high-throughput saliva-based PCR
testing is such a powerful tool in grappling with this global
health crisis,” said Chris Linthwaite, Fluidigm President and CEO.
“In addition to small- and medium-sized labs, large public health
organizations and major academic centers are adopting our
saliva-based test. Health care providers can collect samples far
more easily than with the invasive nasopharyngeal swab and still
have the samples processed with a test that has been demonstrated
to be in 100 percent agreement with authorized nasopharyngeal
assays. Furthermore, the Fluidigm test offers rapid turnaround time
and avoids supply chain constraints of other approaches.
“We are grateful for the opportunity to play a major role in the
response to this pandemic, and we are very pleased with the level
of customer interest in our solution.”
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 ImmunoGenomicsImmunoGenomics is a
scientist-owned-and-operated CLIA-registered reference
laboratory, serving the healthcare community with efficient and
accurate data using cutting edge diagnostic platforms and
technologies. Our Medical Director, Kevin Rosenblatt, MD, PhD, has
extensive experience in the development and
implementation of research to clinical application
in molecular science. As we continue to assist
physicians with diagnostic data using the most sophisticated DNA
sequencing technology, our goal is to simplify our process and
support providers and patients.
About Vero DiagnosticsVero Diagnostics is a
state-of-the-art clinical laboratory that incorporates the latest
technology and methods to provide comprehensive diagnostic testing,
including urine and oral fluid drug monitoring, pathogen detection,
pharmacogenomics, and blood testing. We take pride in our ability
to generate precise and accurate results in a timely manner.
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 benefits and
advantages of the Advanta Dx SARS-CoV-2 RT-PCR Assay, including for
expansion of COVID-19 testing, and customer demand for and
commercialization of the Fluidigm test. 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 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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