Fluidigm Corporation (Nasdaq:FLDM), an innovative
biotechnology tools provider with a vision to improve life through
comprehensive health insight, today announced that the U.S.
Food and Drug Administration (FDA) has granted Emergency Use
Authorization (EUA) for the AZOVA™ COVID-19 Test Collection Kit for
use with the Fluidigm® Advanta™ Dx SARS-CoV-2 RT-PCR Assay on the
company’s Biomark™ HD platform.
The kit is authorized for at-home self-collection by
prescription only for individuals suspected of COVID-19 by their
health care providers. Those under the age of 18 may use the kit
with adult supervision.
Consumers seeking a COVID-19 test can complete an online health
questionnaire provided by Fluidigm’s collaboration partner, AZOVA,
to enable a health care provider to assess whether a prescription
is issued. If so, the consumer can then order the collection kit
online for home delivery.
“We are excited about this collaboration with Fluidigm,” said
Cheryl Lee Eberting, MD, Founder and CEO of AZOVA. “Our goals are
to enable any CLIA-certified laboratory that meets the requirements
to perform high-complexity tests to process our home collection
kits, and to make this kit accessible to as many consumers as
possible. By combining a powerful digital health platform with this
assay, AZOVA and Fluidigm are opening up much greater access to
COVID-19 testing solutions.
“The patient provides a saliva sample as directed in the kit
instructions and sends the kit to one of our partner labs using
prepaid same-day shipping, and results are shared within 12–72
hours of the time the lab receives the kit. The patient receives
text message and email links to securely access results. In
addition, AZOVA creates COVID Credentials™ for each patient, an
electronic passport that enables one to securely share COVID
testing information with others.”
The Advanta Dx SARS-CoV-2 RT-PCR Assay is an extraction-free
saliva-based test to detect nucleic acid from the SARS-CoV-2 virus
in individuals suspected by their health care providers of having
COVID-19. 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.
“Our noninvasive, saliva-based test helped deliver a much-needed
testing solution for patients and first responders around the
world, and we are pleased for the opportunity to introduce the
Advanta Dx SARS-CoV-2 RT-PCR Assay into the home-collection
market,” said Chris Linthwaite, Fluidigm President and CEO.
“Entering the home collection market is an important milestone for
Fluidigm, and collaborations with forward-thinking companies such
as AZOVA to advance into new channels represent a key strategy in
fully realizing Fluidigm’s role in next-generation diagnostics.
“In addition to technological innovation, collaborations in such
areas as telemedicine and new digital health platforms will build
upon the beachhead that we have established to penetrate new
markets. The digital health revolution is here to stay, and we
intend to play a leadership role in this transformation.”
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 UseThe 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
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.
This test is also for use with saliva specimens that are
self-collected at home with or without the supervision of a
healthcare provider (HCP) with the AZOVA COVID-19 Test Collection
Kit from individuals suspected of COVID-19 by their HCP.
Results are for the identification of SARS-CoV-2 RNA. The
SARS-CoV-2 RNA is generally detectable in saliva during the acute
phase of infection. Positive results are indicative of the presence
of SARS-CoV-2 RNA. Clinical correlation with individual history and
other diagnostic information is necessary to determine individual
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 individual management decisions.
Negative results must be combined with clinical observations,
individual 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 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.
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 AZOVAAZOVA provides innovative COVID
testing solutions to employers, schools, government entities,
airlines, the travel industry and the consumer. AZOVA has created
the world’s first truly connected laboratory network on the AZOVA
Digital Health System platform. With AZOVA, any laboratory or
licensed COVID testing location can connect to the global
laboratory network to enable access to COVID testing from anywhere
across the globe.
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 expectations for
adoption and use of a home collection kit for the Advanta Dx
SARS-CoV-2 RT-PCR Assay, demand for COVID-19 testing and Fluidigm’s
role in digital health and next generation diagnostics.
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, 2020, 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
7423
AZOVA
Media:Logan ConnorsMedia Relations844 MY AZOVA ext.
1028logan.connors@azova.com
Investors:Alexander Hume, CFO385 449
1053alexander.hume@azova.com
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