Fulgent Genetics, Inc. (NASDAQ: FLGT) (“Fulgent Genetics” or the
“company”), a provider of comprehensive genetic testing and Next
Generation Sequencing (“NGS”) solutions, today announced the launch
of a Next Generation Sequencing based test for the Coronavirus
Disease (COVID-19). Fulgent’s NGS test will be one of the market’s
first diagnostic tests for the COVID-19 virus developed based on
NGS technology. Fulgent and MedScan will begin accepting specimens
for testing this week from healthcare providers, clinics and
reference labs.
Built on advanced Next Generation Sequencing (NGS) technology,
Fulgent’s COVID-19 test will be more comprehensive compared to
Reverse Transcriptase-Polymerase Chain Reaction (“RT-PCR”) tests on
the market. Fulgent’s test will sequence the entire viral genome,
creating hundreds of targets versus just a few for RT-PCR tests. In
addition, Fulgent’s test will not be limited by a shortage of
reagents, which has proven to be a roadblock for large scale
processing of RT-PCR based tests in the market currently. Fulgent
estimates that its lab will have capacity to process thousands of
samples per day.
MedScan Laboratories is a CLIA certified lab that will collect
samples on behalf of Fulgent and extract RNA for processing.
Fulgent will sequence the viral genome, analyze samples and provide
comprehensive reports back to healthcare providers.
“The surge in cases of COVID-19 in the U.S. and around the world
has created an urgent need for accurate diagnostic testing
solutions for the viral disease,” said Dr. Harry Gao, Chief
Scientific Officer at Fulgent Genetics. “We believe our NGS-based
test for COVID-19 will arm healthcare providers with a better
solution for accurately diagnosing cases of the disease. In
addition, the virus mutation data we collect from this NGS based
test could be extremely valuable to researchers in the future to
predict the clinical outcome and potentially develop treatment
options and vaccines for this virus.”
Fulgent Genetics is uniquely well-positioned to develop and
offer a Next Generation Sequencing based test for COVID-19 given
the company’s presence on the ground in China through its joint
venture, which has provided access to real positive controls and
unique data insights from patients in China.
Fulgent Genetics’ joint venture in China, which was established
in 2016, recently executed a research agreement for COVID-19 with
the Chinese Academy of Medical Sciences and Peking Union Medical
College Hospital (“PUMCH”), both for diagnostic and mutation
analysis of the virus. Fulgent Genetics, through its China JV and
with strong cooperation with PUMCH, began collecting patient
samples beginning January of 2020 from the most affected regions of
China for research, development, analysis, testing, and validation.
Leveraging Fulgent’s NGS-based test, a large-scale study on these
samples is ongoing to better understand how the virus sequence
changes over time, and the association of virus mutations with
clinical outcomes. The data may also help to predict pathogenicity
and infectivity to assist in future drug or vaccine
development.
Fulgent plans to submit its NGS test to the U.S. Food and Drug
Administration (FDA) for validation and emergency use authorization
in the coming weeks. While FDA approval is not required for labs to
collect samples and perform diagnostic testing, such approval could
help to facilitate broader adoption of the test.
For more information about COVID-19 testing options from Fulgent
Genetics and MedScan Laboratories, 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.
About MedScan
MedScan laboratory is located in Williston, ND. It was started
in 1999 as a toxicology lab testing for drugs of abuse. Since that
time MedScan has grown to service accounts in every state with the
exception of New York. MedScan utilizes the most advanced
technology in the toxicology market which allows it to have some of
the lowest detection limits in comparison to their competitors.
MedScan also performs an extensive array of blood tests for their
clients. In 2016, Medscan started its sister company, Altru
Diagnostics, in Houston, TX to expand their testing capabilities to
include molecular and genetic testing.
About Peking Union Medical College Hospital
Peking Union Medical College Hospital (PUMCH) is a Class A
tertiary comprehensive hospital committed to delivering
state-of-the-art clinical care, innovative scientific research and
rigorous medical education. It is designated by the Chinese
National Health Commission as one of the national referral centers
offering diagnostic and therapeutic care of complex and rare
disorders, national demonstrative bases for higher medical
education and standardized residency training, core national for
clinical research and technological innovation, as well as one of
the earliest Chinese hospitals offering medical care to senior
leaders and foreign patients. PUMCH enjoys high reputation for its
full range of disciplines, cutting-edge technologies and
outstanding specialties. According to “China's Hospital Rankings”
released by Hospital Management Institute, Fudan University, PUMCH
has topped the ranking for consecutively 10 years.
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.com
For More Information on Fulgent’s COVID-19 NGS
Test:Covid19@fulgentgenetics.com
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