Fulgent Genetics Provides Update on Testing for COVID-19
April 09 2020 - 8:00AM
Fulgent Genetics, Inc. (NASDAQ: FLGT) (“Fulgent Genetics” or the
“company”), a provider of comprehensive genetic testing and Next
Generation Sequencing (“NGS”) solutions, today announced that it is
offering end-to-end processing, analysis and reporting for its
recently launched COVID-19 tests. The company is currently
accepting samples directly to its BSL-2 certified lab in Temple
City, California, versus previously accepting extracted RNA samples
through third party laboratories.
With the ability to offer end-to-end testing for COVID-19,
Fulgent can more efficiently manage the demand it is seeing for
both its RT-PCR and NGS tests for the virus. The company’s lab has
the capacity to accept and process thousands of samples per day for
COVID-19 testing alone.
“Fulgent’s proprietary and flexible technology platform has
enabled us to rapidly pivot our resources amid the need for
COVID-19 testing solutions, and we have been able to apply our
experience and know-how to help meet testing needs during this
pandemic,” said Brandon Perthuis, Fulgent’s Chief Commercial
Officer. “Rapid turnaround time has also been crucial in effective
testing for COVID-19, and over the few weeks that Fulgent has
offered testing, over 95% of our reports have been delivered to
providers within 24 hours, and many have been delivered within the
same day.”
In conjunction with the new tests for the COVID-19 virus,
Fulgent also launched a new web-based portal for the delivery of
COVID-19 test results. This portal has been customized to make it
easy for physicians to access their results across multiple
platforms, and allows physicians to track samples in progress to
quickly determine whether results are positive, negative or
indeterminate.
Fulgent also announced that it has submitted several COVID-19
tests to the US Food and Drug Administration (FDA) for Emergency
Use Authorization (EUA) in the US. The company is currently
awaiting responses from the FDA. In addition, the company has
received temporary approval from the State of New York to perform
COVID-19 testing on specimens from New York. As a reminder, the
company previously received its permit and genetic test approval
from the New York Department of Health in 2019.
For more information about COVID-19 testing options from Fulgent
Genetics please visit www.fulgentgenetics.com/COVID19 or email
the Fulgent team directly at covid19@fulgentgenetics.com.
Providers should refer to the most current CDC guidelines for
further information on appropriate testing of patients, available
here
www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-criteria.html.
About Fulgent Genetics
Fulgent Genetics is a growing technology company with an initial
focus on offering comprehensive genetic testing to provide
physicians with clinically actionable diagnostic information they
can use to improve the quality of patient care. The company has
developed a proprietary technology platform that integrates
sophisticated data comparison and suppression algorithms, adaptive
learning software, advanced genetic diagnostics tools and
integrated laboratory processes. This platform allows the company
to offer a broad and flexible test menu and continually expand and
improve its proprietary genetic reference library, while
maintaining accessible pricing, high accuracy and competitive
turnaround times. The company believes its current test menu, which
includes approximately 18,000 single-gene tests and more than 850
pre-established, multi-gene, disease-specific panels, offers more
genes for testing than its competitors in today’s market, which
enables it to provide expansive options for test customization and
clinically actionable results.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. Examples of forward-looking statements in this press release
include statements about, among other things: anticipated timing,
availability, demand for and effectiveness of the company’s testing
products for COVID-19.
Forward-looking statements are statements other than historical
facts and relate to future events or circumstances or the company’s
future performance, and they are based on management’s current
assumptions, expectations and beliefs concerning future
developments and their potential effect on the company’s business.
These forward-looking statements are subject to a number of risks
and uncertainties, which may cause the forward-looking events and
circumstances described in this press release to not occur, and
actual results to differ materially and adversely from those
described in or implied by the forward-looking statements. These
risks and uncertainties include, among others: the market potential
for, and the rate and degree of market adoption of, the company’s
tests and genetic testing generally; the company’s ability to
maintain the low internal costs of its business model; the
company’s ability to maintain an acceptable margin on sales of its
tests, particularly in light of increasing competitive pressures
and other factors that may continue to reduce the company’s sale
prices for and margins on its tests; risks related to volatility in
the company’s results, which can fluctuate significantly from
period to period; the company’s investments in its infrastructure,
including its sales organization and operational capabilities, and
the extent to which these investments impact the company’s business
and performance and enable it to manage any growth it may
experience in future periods; the company’s level of success in
obtaining coverage and adequate reimbursement and collectability
levels from third-party payors for its tests; the company’s level
of success in establishing and obtaining the intended benefits from
partnerships, joint ventures or other relationships; the company’s
compliance with the various evolving and complex laws and
regulations applicable to its business and its industry; risks
associated with the company’s international operations; the
company’s ability to protect its proprietary technology platform;
and general industry, economic, political and market conditions. As
a result of these risks and uncertainties, forward-looking
statements should not be relied on or viewed as predictions of
future events.
The forward-looking statements made in this press release speak
only as of the date of this press release, and the company assumes
no obligation to update publicly any such forward-looking
statements to reflect actual results or to changes in expectations,
except as otherwise required by law.
The company’s reports filed with the Securities and Exchange
Commission, including its annual report on Form 10-K for the year
ended December 31, 2019 and the other reports it files from time to
time, including subsequently filed quarterly and current reports,
are made available on the company’s website upon their filing with
the Securities and Exchange Commission. These reports contain more
information about the company, its business and the risks affecting
its business.
Investor Relations Contact:The Blueshirt
GroupNicole Borsje, 415-217-2633, nborsje@blueshirtgroup.comMelanie
Solomon, 415-217-4964, melanie@blueshirtgroup.com
For More Information on Fulgent’s COVID-19
Tests:Covid19@fulgentgenetics.com
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