Fluidigm Corporation (Nasdaq:FLDM), an innovative
biotechnology tools provider with a vision to improve life through
comprehensive health insight, today announced that it has partnered
with Healthvana Inc., the nation’s leading patient platform for
delivering COVID-19 test results, to provide clinical laboratory
customers utilizing the Fluidigm® saliva-based Advanta™ Dx
SARS-CoV-2 RT-PCR Assay with the option to deliver test results
faster via Healthvana’s mobile platform.
“We are witnessing record-breaking infection rates, and
shortening the time for the result to get to the patient is
paramount,” said Ramin Bastani, CEO of Healthvana. “On average,
after clinical laboratories return COVID-19 test results, we have
found that patients view their result within 30 minutes when
Healthvana acts as the ‘last mile.’”
Healthvana’s patient-friendly mobile platform delivers test
results directly to patients and is tailored to reduce anxiety
through easy-to-understand test result information, education and
next steps. Patients can access their health information in less
than a minute, in multiple languages, and print or download it to
show a negative COVID-19 test result before going to school or work
or getting on a plane.
Healthvana has partnered with states, local governments, labs,
employers and schools to deliver more than 3 million COVID-19 test
results since April.
“Since the onset of the global health crisis, companies,
universities, governmental entities and others have demonstrated an
ability to pivot rapidly and innovate in ways that move us another
step closer to effectively managing through this pandemic,” said
Chris Linthwaite, President and CEO of Fluidigm. “This spirit of
collaborative problem solving is evident in the patient-focused
delivery platform developed by Healthvana, and Fluidigm is pleased
to have the opportunity to offer this game-changing tool to our
clinical laboratory customers. We believe that Healthvana’s
delivery platform and our testing technology will be an
extraordinarily effective combination.”
Fluidigm in late August received Emergency Use Authorization
(EUA) from the U.S. Food and Drug Administration 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. The company’s
clinical study submitted to the FDA demonstrated 100 percent
agreement between saliva results from the Advanta Dx SARS-CoV-2
RT-PCR 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 CLIA
laboratories can combine with commonly available automation
platforms.
Intended Use 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 health care
provider. Testing is limited to laboratories that are certified
under the Clinical Laboratory Improvement Amendments of 1988
(CLIA), 42 U.S.C. §263a, and that 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 positive 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.
The Advanta Dx SARS-CoV-2 RT-PCR Assay is
for In Vitro Diagnostic
Use. It is for Use Under Emergency Use Authorization Only. Rx
Only. It has not been FDA cleared or approved. It has
been authorized by FDA under an EUA for use by authorized
laboratories. It has been authorized only for the detection of
nucleic acid from SARS-CoV-2, not for any other viruses or
pathogens. It is only authorized for the duration of the
declaration that circumstances exist justifying the authorization
of emergency use of in vitro diagnostics for detection
and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21
U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or
revoked sooner. Other Fluidigm products are
For Research Use Only. Not for use in diagnostic
procedures.
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 HealthvanaHealthvana’s
mission is to help eliminate COVID-19 using technology. Since 2015,
the mobile-first patient portal has been rooted in empathy,
enabling HIPAA-compliant test results to be easily and quickly
distributed to patients. Healthvana gives patients the ability to
access their own health results anytime, while providing cities,
labs, health systems, employers, skilled nursing facilities,
homeless shelters and schools the ability to reduce costs, manage
patient communication and inspire informed action for better
outcomes.
Los Angeles-based Healthvana focuses solely on anxiety-provoking
health information, and serves as the largest patient communication
platform for COVID-19 and HIV in the U.S. For more information,
visit www.healthvana.com.
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 the anticipated
benefits of a collaboration relating to communication of COVID-19
testing results from Fluidigm clinical laboratory customers to such
customers’ patients. 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
during 2020; 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
Healthvana
Innsena for HealthvanaMackenzie
Kreitlermackenziekreitler@innsena.com603 521 4864
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