Fluidigm Corporation (Nasdaq:FLDM), an innovative biotechnology
tools provider with a vision to improve life through comprehensive
health insight, today announced that Fluidigm® mass cytometry
technology and the Maxpar® Direct™ Immune Profiling Assay™ will be
used in a longitudinal study of approximately 250 pediatric
patients infected with SARS-CoV-2, the virus that causes COVID-19.
The study on immune system activity in SARS-CoV-2 positive
children, Pediatric Research Immune Network on SARS-CoV-2 and MIS-C
(PRISM) (NCT04588363), will compare data from those with
asymptomatic infections, mild COVID-19 and multisystem inflammatory
syndrome (MIS-C). A goal of the PRISM study is to characterize the
immunologic pathways associated with different disease
presentations and outcomes.
“In the U.S. alone, more than 1,650 children have been diagnosed
with MIS-C, which typically begins several weeks after SARS-CoV-2
exposure. MIS-C is a potentially life-threatening condition marked
by severe inflammation of one or more bodily organs,” said Sheri M.
Krams, PhD, Professor of Surgery and Senior Associate Dean for
Graduate Education and Postdoctoral Affairs at Stanford University
School of Medicine.
Krams is a lead researcher on the study, along with Olivia M.
Martinez, PhD, Professor of Surgery at Stanford Medicine.
“Little is known about the immunologic mechanisms and
characteristics associated with different forms of MIS-C and
COVID-19 in children,” Krams said. “The study aims to fill gaps in
understanding the clinical spectrum of COVID-19 in children and
young adults, the long-term outcomes of SARS-CoV-2 infection in
these populations and the underlying immunologic basis of MIS-C.
This knowledge could be extremely valuable in preventing, managing
and developing effective therapies for this dangerous consequence
of SARS-CoV-2 infection.”
The study is expected to enroll about 250 SARS-CoV-2 infected
patients under age 21 from diverse racial and ethnic backgrounds.
Blood samples will be collected at 20 clinical sites and will be
sent to Stanford for evaluation using the Fluidigm Maxpar Direct
Immune Profiling Assay on the company’s Helios™ CyTOF® system.
The study will utilize Fluidigm’s unique Cell-ID™ 20-Plex Pd
Barcoding Kit to allow up to 20 tests to be performed in a single
run. Fluidigm’s automated Maxpar Pathsetter™ and debarcoding
software will be used to analyze the data generated with the
assay.
Blood samples will be collected from each patient four times
over the course of a year in order to evaluate changes in immune
system activity and correlate this activity with each patient’s
COVID-19 status and clinical experience.
“We are gratified that our suite of mass cytometry and Maxpar
technologies is helping to advance our understanding of COVID-19
and will provide researchers and clinicians with information that
can help improve management, treatment and outcomes for patients
with the disease,” said Chris Linthwaite, President and CEO of
Fluidigm. “MIS-C is a dangerous and unpredictable consequence of
COVID-19 in some children, and we hope that the insights gleaned
from Stanford’s analyses will help prevent MIS-C or improve patient
outcomes.
“Data from this study will join a growing body of peer-reviewed
research based on mass cytometry and Maxpar technologies. That
research includes a recent study that identified a distinct
phenotype in patients with severe COVID-19, as well as an ongoing
NIH sponsored study titled Immunophenotyping Assessment in a
COVID-19 Cohort (IMPACC), which is exploring how certain
immunological responses correspond to, or may even predict, the
clinical severity of COVID-19 and may inform recommendations for
COVID-19 care.”
Two other National Clinical Trials are also employing the Maxpar
assay:
- COvid-19 Advanced
Genetic and Immunologic Sampling (COntAGIouS), NCT04327570, has the
goal of identifying factors that result in hypersusceptibility to
SARS-CoV-2 infection.
- Antidepressant Trial
with P2X7 Antagonist JNJ-54175446 (ATP), NCT04116606, is designed
to assess changes in peripheral blood immune cell populations at
baseline and after treatment.
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, Cell-ID, CyTOF, Direct,
Helios, Immune Profiling Assay, Maxpar, and Pathsetter 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. For Research Use Only. Not for use in
diagnostic procedures.
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
the use of Fluidigm mass cytometry technology and products for a
COVID-19 related study and the design and goals of that study.
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; 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; competition; and
reductions in research and development spending or changes in
budget priorities by customers. 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
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