Fulgent Genetics Receives Emergency Use Authorization from the FDA for its RT-PCR Test for Detection of SARS-CoV-2, the Virus...
18 May 2020 - 8:00PM
Fulgent Genetics, Inc. (NASDAQ: FLGT) (“Fulgent Genetics” or the
“company”), a provider of comprehensive genetic testing solutions,
today announced that its subsidiary, Fulgent Therapeutics, LLC, has
received Emergency Use Authorization (EUA) from the US Food and
Drug Administration (FDA) for its RT-PCR test for the detection of
SARS-CoV-2, the virus that causes COVID-19, using upper respiratory
specimens (nasal, nasopharyngeal, and oropharyngeal swabs). The
company is offering end-to-end processing, analysis and reporting
for its COVID-19 tests through its BSL-2, CLIA-certified lab in
Temple City, California.
In addition, the EUA allows for the test to be used with nasal
swab specimens which are either self-collected by patients at home
or in a health care setting using an authorized at-home collection
kit offered by a third party, when determined to be appropriate by
a health care provider. Fulgent’s EUA enables the company to
process these samples at its lab in Temple City.
“I am proud of the work our team has done to receive this EUA
from the FDA for our RT-PCR test for COVID-19,” said Ming Hsieh,
Chairman and Chief Executive Officer of Fulgent Genetics. “We look
forward to further contributing to the fight against this global
pandemic by increasing the availability of reliable testing options
for COVID-19.”
Fulgent Genetics’ RT-PCR test for the Coronavirus is a reverse
transcription polymerase chain reaction test to detect SARS-CoV-2.
The SARS-CoV-2 primer and probe sets are designed to detect RNA
from 2019-nCoV in specimens from patients who meet CDC 2019-nCoV
clinical criteria. Primer and probe set sequences are based on CDC
recommended guidelines that identify two known distinct regions
within the SARS-CoV-2 genome. Amplification of both targets will
signify a positive result; amplification of one of two targets will
signify an indeterminate (inconclusive) result; and no
amplification of either target, but amplification of internal
control, will signify a negative result. Inconclusive results will
require a new sample for testing.
Fulgent Genetics’ RT-PCR test for COVID-19 has been granted an
EUA by the FDA only for the detection of nucleic acid from
SARS-CoV-2, not for any other viruses or pathogens.
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.
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
services 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 quarterly report on Form 10-Q for the
quarter ended March 31, 2020 as filed with the SEC on May 6, 2020
and the other reports it files from time to time, including
subsequently filed annual, 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
Media Contact:The Blueshirt GroupJeff Fox;
jeff@blueshirtgroup.commedia@picturegenetics.com
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