Key Regulatory Body in India Grants Commercial License for Fluidigm Saliva-Based Advanta Dx SARS-CoV-2 RT-PCR Assay
November 24 2020 - 8:30AM
Fluidigm Corporation (Nasdaq:FLDM), an innovative
biotechnology tools provider with a vision to improve life through
comprehensive health insight, today announced that the Central
Drugs Standard Control Organisation (CDSCO) in India has licensed
importation and commercial sale of the Fluidigm® Advanta™ Dx
SARS-CoV-2 RT-PCR Assay in that country for COVID-19 testing. The
CDSCO license was granted to Premas Life Sciences, a Delhi based
life sciences distribution company.
In India, the CDSCO leads regulatory approval for vaccines,
diagnostics, prophylactics, and therapeutics designed to prevent or
treat diseases including COVID-19. The Fluidigm test is one of the
first saliva-based tests for COVID-19 to be licensed in India. The
license granted to Premas Life Sciences provides for the Fluidigm
assay to be used to track positive cases of COVID-19 using
laboratories designated/approved by the Indian Council of Medical
Research or the relevant state or central government.“Premas Life
Sciences has a passion for delivering game-changing technologies
across an array of research and diagnostic areas,” said Praveen
Gupta, Managing Director of Premas Life
Sciences. “Fluidigm’s much-needed noninvasive
saliva-based test comes at a critical time in the pandemic, and we
are pleased to be able to facilitate availability of the Advanta
assay in India.”India's reported coronavirus cases have surpassed 9
million, a total so far exceeded only by the United States.“Since
announcing our Emergency Use Authorization in the United States for
saliva-based PCR testing, we have seen growing interest in our
technology,” said Chris Linthwaite, Fluidigm President and CEO.
“License to market our Advanta Dx SARS-CoV-2 RT-PCR Assay in the
world’s second-most populous nation will enable an effective and
scalable way to get noninvasive saliva-based testing across India
as a possible second wave of infections approaches.“We are now in
discussions with potential customers, which include private testing
labs as well as academic institutions and government medical
centers. We are honored for the opportunity to advance the
availability of noninvasive saliva-based COVID-19 testing in India
at this critical time.”The Fluidigm assay does not require
collection via invasive nasopharyngeal swab. The company’s clinical
study submitted to the U.S. Food and Drug Administration
demonstrated 100 percent agreement between saliva results from the
Advanta assay and results from paired nasopharyngeal samples tested
with authorized assays.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 can be
combined with commonly available automation platforms.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 products are provided for Research
Use Only. Not for use in diagnostic procedures.
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.
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
distribution of and demand for Fluidigm’s Advanta Dx SARS-CoV-2
RT-PCR Assay in India. 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 6621mark.spearman@fluidigm.com
Investors:Agnes LeeVice President, Investor Relations650 416
7423agnes.lee@fluidigm.com
Fluidigm (NASDAQ:FLDM)
Historical Stock Chart
From Aug 2024 to Sep 2024
Fluidigm (NASDAQ:FLDM)
Historical Stock Chart
From Sep 2023 to Sep 2024