Fulgent Genetics Announces FDA Authorization and Launch of At-Home Testing Service for COVID-19
June 16 2020 - 4:05PM
Fulgent Genetics, Inc. (NASDAQ: FLGT) (“Fulgent Genetics” or the
“company”), a provider of comprehensive genetic testing solutions,
today announced that it has launched an at-home testing solution
for the Coronavirus Disease (COVID-19). The company has received
Emergency Use Authorization (EUA) from the US Food and Drug
Administration (FDA) for use in the United States.
Fulgent Genetics will be offering the testing service through
Picture Genetics, the company’s consumer-initiated genetic testing
platform, beginning next week. Individuals interested in ordering
testing services must qualify for the service through an online
eligibility screener, which makes eligibility determinations based
on current CDC guidelines while prioritizing those who are most in
need of testing. Eligible individuals will receive Fulgent’s
collection materials in the mail that enable them to self-collect
their specimen with a mid-turbinate nasal swab, which will then be
sent back to Fulgent’s CLIA-certified high-complexity,
CAP-accredited laboratory in Temple City, California. By enabling
individuals to collect samples themselves, Fulgent’s at-home test
services conserve valuable time and PPE resources otherwise
required to perform these testing services for patients. Patients
will receive their results through the Picture Genetics platform
within 24-48 hours from receipt of the sample.
Fulgent has partnered with a national clinician network on its
at-home COVID-19 test which will oversee the process including
approval of each test ordered, monitoring of materials produced,
and review of reports provided for patients by Fulgent Genetics
after testing is completed.
“We are pleased to be able to offer a convenient and readily
available COVID-19 testing solution for individuals at risk of
contracting the virus,” said Brandon Perthuis, Chief Commercial
Officer at Fulgent Genetics. “As the coronavirus continues to
spread, options for testing remain limited and many eligible
individuals are unable to get the testing they need. We believe our
at-home testing service will both enable at-risk individuals,
particularly those at the front lines of this pandemic, to more
readily access testing solutions, while potentially offering a
solution for organizations to screen employees as they return to
work. We believe that increasing availability of at-home testing
solutions in general will help to alleviate congestion at health
care facilities, reduce contribution to more community spread, and
offer individuals who are unable to leave their homes a safer and
more convenient testing solution,” further commented Perthuis.
“Since launching our RT-PCR Test (non at-home test) several months
ago, we have won several strategic accounts and are processing
thousands of tests daily with an average turnaround time of 24
hours from receipt of sample. This at-home COVID-19 test will
diversify our go-to-market approach for tests by utilizing our
existing consumer-initiated genetic testing platform.”
Fulgent Genetics’ at-home test service 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.
Individuals interested in determining their eligibility for
at-home test services from Fulgent Genetics can find more
information on the Picture Genetics website at
www.picturegenetics.com/covid19.
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 Picture Genetics
Picture Genetics was founded in 2019 as a division of Fulgent
Genetics. Picture Genetics offers consumers direct access to
Fulgent’s advanced genetic testing and analytics capabilities from
the ease and comfort of home, at an affordable price point. Picture
Genetics provides a holistic approach to at-home genetic screening
by including oversight from independent physicians as well as
genetic counseling options to complement Fulgent’s comprehensive
genetic testing analysis. Picture Genetics currently offers
multiple tests that provide medically actionable, clinical-level
results with professional medical follow-up in one easy process.
Visit www.picturegenetics.com for more information.
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, test result processing timing, go-to-market-approach,
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 annual 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 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
GroupMelanie Solomon, 415-217-4964, melanie@blueshirtgroup.com
Media Contact:The Blueshirt GroupJeff Fox,
jeff@blueshirtgroup.commedia@picturegenetics.com
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