Fulgent Genetics Launches At-Home Neutralizing Antibody Test for COVID-19
2021年10月27日 - 9:00PM
ビジネスワイヤ(英語)
Fulgent Genetics, Inc. (NASDAQ: FLGT) (“Fulgent” or the
“Company”), a technology-based genetic testing company focused on
transforming patient care in oncology, infectious and rare
diseases, and reproductive health, today announced that it has
launched an antibody test for COVID-19 which will specifically
target neutralizing antibodies. The test will be available through
the Company’s consumer initiated platform, Picture Genetics.
Fulgent aims to empower individuals with better data on their
potential resistance levels to COVID-19 by making antibody testing
readily available to consumers through its Picture Genetics
platform. This lab developed test is performed with a finger prick
in the comfort of a patient’s home, with no need for a physician
visit and venipuncture. By expanding access to this antibody data,
we hope to better understand the long-term effectiveness of
vaccines and potential herd immunity to COVID-19.
Unlike typical antibody tests that detect all antibodies in
patients, Fulgent’s antibody test will specifically detect the
level of neutralizing antibodies in patients from a recent COVID-19
infection, or those who have been vaccinated against the virus.
Neutralizing antibodies are unique in that they bind to a specific
part of a pathogen and have been observed to decrease SARS-CoV-2
viral infection of cells, thus targeting these specific antibodies
gives us better insight into the level of immunity of a patient.
The detection of neutralizing antibodies in patients requires a
higher level of specificity and sensitivity given antibodies can
rapidly decrease within the months following a COVID-19 infection
or vaccination. Immunity to SARS-CoV-2 and its variants is not yet
well understood as research on the topic is ongoing.
“With the launch of our neutralizing antibody test, we hope to
provide patients and healthcare providers with better data on
immunity to COVID-19, whether from the vaccine or a previous
infection,” said Dr. Harry Gao, Chief Scientific Officer of
Fulgent. “While we cannot yet conclude whether the presence of
neutralizing antibodies guarantees immunity against a COVID-19
infection, we hope that this test can help determine immunity
levels and the need for vaccine boosters across the population and
help to improve our country’s overall response to the virus.”
Fulgent has become a leader in COVID-19 testing having conducted
more than 12 million COVID-19 tests for customers since the onset
of the pandemic. The addition of COVID-19 neutralizing antibody
testing complements the Company’s existing RT-PCR and Next
Generation Sequencing based tests for the virus.
About Fulgent Genetics
Fulgent Genetics is a technology-based genetic testing company
focused on transforming patient care in oncology, infectious and
rare diseases, and reproductive health. Fulgent’s proprietary
technology platform has created a broad, flexible test menu and the
ability to continually expand and improve its proprietary genetic
reference library while maintaining accessible pricing, high
accuracy, and competitive turnaround times. Combining next
generation sequencing (“NGS”) with its technology platform, the
Company performs full-gene sequencing with deletion/duplication
analysis in an array of panels that can be tailored to meet
specific customer needs. A cornerstone of the Company’s business is
its ability to provide expansive options and flexibility for all
clients’ unique testing needs through a comprehensive technology
offering including cloud computing, pipeline services, record
management, web portal services, clinical workflow, sequencing as a
service and automated lab services.
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: Fulgent’s testing
solutions and services, including its laboratory capacity and
related matters; the Company’s identification and evaluation of
opportunities, estimates of market size and its ability to
capitalize on opportunities to grow its business.
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 ongoing impacts
of the COVID-19 pandemic, including the preventive public health
measures that may continue to impact demand for its genetics tests
and the pandemic’s effects on the global supply chain; the market
potential for, and the rate and degree of market adoption of, the
Company’s tests, including its newly-developed tests for COVID-19
and genetic testing generally; the Company’s ability to capture a
sizable share of the developing market for genetic and COVID-19
testing and to compete successfully in these markets, including its
ability to continue to develop new tests that are attractive to its
various customer markets, its ability to maintain turnaround times
and otherwise keep pace with rapidly changing technology; the
Company’s ability to successfully integrate acquired businesses and
assets into its business strategy and to derive value from its
investments; the Company’s ability to maintain the low internal
costs of its business model, particularly as the Company makes
investments across its business; 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; risks associated
with the composition of the Company’s customer base, which can
fluctuate from period to period and can be comprised of a small
number of customers that account for a significant portion of the
Company’s revenue; the Company’s ability to grow and diversify its
customer base and increase demand from existing and new customers;
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 CSI,
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 U.S. Securities and
Exchange Commission (“SEC”), including its annual report on Form
10-K for the year ended December 31, 2020 filed with the SEC on
March 8, 2021 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
SEC. These reports contain more information about the Company, its
business and the risks affecting its business.
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version on businesswire.com: https://www.businesswire.com/news/home/20211027005394/en/
Investor Relations Contacts: The Blueshirt Group Nicole
Borsje, 415-217-2633; nicole@blueshirtgroup.com
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