Fluidigm Corporation (Nasdaq:FLDM), an innovative
biotechnology tools provider with a vision to improve life through
comprehensive health insight, today announced that the company
has received the CE-IVD mark for its 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 CE-IVD mark is in conformance with
the European Union In Vitro Diagnostic Directive.
The Advanta Dx SARS-CoV-2 RT-PCR Assay does not require
collection via invasive nasopharyngeal swab, and the company’s
clinical studies for submission 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 collection. 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.
“Since introduction of our saliva-based COVID-19 testing
solution in the United States, we have seen tremendous interest in
our testing technology, and we are gratified by the opportunity to
offer one of the first saliva-based COVID-19 tests to be widely
available in Europe, where the total addressable market for
COVID-19 testing, based on third-party and company estimates, is $5
billion to $7 billion in 2021,” said Chris Linthwaite,
Fluidigm President and CEO. “The European region is currently
reporting a million new infections every four days and has seen
more than 27 million cases since the pandemic began.
“In the first phase of the pandemic, we served the European
market via home-brew laboratory COVID-19 tests. We are excited for
the opportunity to now distribute Fluidigm CE-IVD commercial kits
via our direct sales force and distribution partners, including for
potential screening applications that may not require an order from
a health care provider. We anticipate offering the Advanta Dx
SARS-CoV-2 RT-PCR Assay for as little as 5 euros per test, based on
volume and other factors.
“This much-needed noninvasive testing solution is being
delivered in Europe at a critical time in the global health crisis.
We anticipate strong interest from private labs that support
testing for travel, workplace and other environments, and we
believe high-throughput Fluidigm technology and the extraction-free
nature of the assay will be among key drivers in Europe.
Furthermore, our assay features an integrated testing platform and
a reliable supply chain that laboratories can combine with commonly
available automation platforms.”
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 Use
The Advanta™ Dx SARS-CoV-2 RT-PCR Assay is a reverse
transcription (RT) and real-time polymerase chain reaction (PCR)
test intended for the qualitative detection of nucleic acid from
SARS-CoV-2 in saliva from patients who are suspected of
COVID-19.
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.
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.
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.
Other Fluidigm products are For Research Use
Only. Not for use in diagnostic procedures.
About Fluidigm
Fluidigm (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, and CyTOF are
trademarks and/or registered trademarks of Fluidigm
Corporation in the United States and/or other
countries.
Forward-Looking Statements for Fluidigm
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995, including, among others, statements regarding introduction
and delivery of the Advanta Dx SARS-CoV-2 RT-PCR Assay in Europe,
anticipated pricing and distribution channels for the assay,
features and benefits of the assay, the potential European market
size for COVID-19 testing, and demand for the assay in Europe.
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 Information
We 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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