Fluidigm Corporation (Nasdaq:FLDM), an innovative
biotechnology tools provider with a vision to improve life through
comprehensive health insight, today announced that Helix
Specialty Diagnostics is partnering with Genomic LTC DX to provide
COVID-19 testing using the Advanta™ Dx SARS-CoV-2 RT-PCR Assay on
the Fluidigm® Biomark™ HD system.
Both Missouri based companies operate major
Clinical Laboratory Improvement Amendments (CLIA) certified labs.
Helix Specialty Diagnostics leads sample collection for the
collaboration, with Genomic LTC DX processing and analyzing the
saliva samples via the Advanta Dx Assay on the Biomark HD.
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. 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 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.
“Our experience collecting samples and reporting
clinical results at scale is further expanded by Genomic LTC DX
processing test samples utilizing the Fluidigm assay on the Biomark
HD,” said Michael Paulsen, President, Helix Specialty Diagnostics.
“High-throughput saliva-based PCR testing is a valuable tool for
colleges and universities as well as long-term care facilities,
both of which are major customers. We intend to deliver 3,000 tests
per day for processing via the Fluidigm system, providing
much-needed additional capacity for large-scale testing
programs.
“Rapid and reliable COVID-19 testing, made
available to all who need it, is essential for a sustained response
to the pandemic. As the total number COVID-19 cases in the United
States exceeds 25 million, we are gratified by the opportunity to
partner with Genomic LTC DX and Fluidigm to meet the needs of our
clients.”
“Fluidigm is committed to provide the technology
to enable simple, affordable and accessible testing capability to
help keep colleges and universities open and keep high-risk
residents of long-term facilities healthy,” said Chris
Linthwaite, Fluidigm President and CEO. “We are proud of
our collaborations in Missouri in recent months, starting with
Washington University in St. Louis, and later with the State of
Missouri, which has deployed four Fluidigm systems to various
locations. Furthermore, we are excited to expand into the
private-sector testing market through Helix Specialty Diagnostics
and Genomic LTC DX to expand testing capacity for the state.
“Our 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 various
community populations. Furthermore, 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.”
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
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 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,
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 Helix Specialty
DiagnosticsHelix Specialty Diagnostics (HSD) is a CLIA
certified high complexity clinical testing laboratory located in
Columbia, MO. The ownership of HSD represents over 150 years of
healthcare and laboratory experience. HSD is passionate about
healthcare and about delivering high quality results to improve
patient outcomes. Centrally located in the state, HSD is
well-positioned to receive samples from all areas of Missouri and
the surrounding states. HSD is committed to working with the
employers to help them through this unprecedented time.
About Genomic LTC DXGenomic LTC
DX is the wholly owned division of Boyce and Bynum Pathology
Professional Services (BBPPS), dedicated to providing access to
advanced diagnostic solutions to patients and clinicians across the
Midwest. Established in 1965, Boyce and Bynum Pathology
Professional Services is the largest private anatomic pathology
reference laboratory in the Midwest, offering a full spectrum of
anatomic procedures and operating under the directorship of
multi-specialty pathologists who are committed to meeting the needs
of the hospitals, specialty clinics, physician offices, and the
communities that we serve.
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
expectations for specified third parties to conduct COVID-19
testing using the Advanta Dx SARS-CoV-2 RT-PCR Assay, the benefits
and relative accuracy of 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, demand for
the Fluidigm tests and expansion of testing capacity based on
availability of 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 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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