Fulgent Genetics Adds Influenza A and Influenza B to all COVID-19 Tests
September 03 2020 - 6:00AM
Fulgent Genetics, Inc. (NASDAQ: FLGT) (“Fulgent Genetics” or the
“company”), a technology company providing comprehensive testing
solutions through its scalable technology platform, today announced
that beginning September 28th, all patients tested for COVID-19 by
Fulgent Genetics will also receive results for Influenzas A and
B.
“With flu season fast approaching, we believe it will be
critical to differentiate between Influenza and SARS-CoV-2, and
that this combination of virus testing will become the standard of
care during the remainder of the pandemic. Adding Influenza A and B
testing to our COVID-19 testing solution further solidifies Fulgent
Genetics as the go-to laboratory for testing during this pandemic,
as it has become increasing clear that RT-PCR is the gold standard
for COVID-19 testing,” commented Brandon Perthuis, Chief Commercial
Officer of Fulgent Genetics. “While some non-RT-PCR tests have the
potential to deliver faster results, the sensitivity and
specificity of our RT-PCR test for COVID-19, especially at
low-level viral loads, is critical to minimize both false positives
and false negatives. We believe RT-PCR testing solutions are
currently the most viable solution for asymptomatic testing, early
detection after potential exposure and for preventative screening.
Finally, while some labs have difficulty delivering results within
their projected turn-around-times for RT-PCR tests, Fulgent has
consistently delivered RT-PCR testing results within 24 hours from
receipt of sample,” Perthuis added.
The addition of Influenza A and B testing will apply to all
Fulgent COVID-19 tests and platforms including drive-through
testing, enterprise testing for back-to-work and back-to-school,
facility-based testing, as well as its FDA authorized Picture
at-home test.
About Fulgent Genetics
Fulgent Genetics’ 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. In 2019, the Company
launched its first patient-initiated product, Picture Genetics, a
new line of at-home screening tests that combines the Company’s
advanced NGS solutions with actionable results and genetic
counseling options for individuals. Since March 2020, the Company
has commercially launched several tests for the detection of
SARS-CoV-2, the virus that causes the novel coronavirus
(“COVID-19”), including NGS and reverse transcription polymerase
chain reaction (“RT-PCR”) - based tests. The Company has received
Emergency Use Authorization (“EUA”) from the U.S. Food and Drug
Administration (“FDA”) for the RT-PCR-based tests for the detection
of SARS-CoV-2 using upper respiratory specimens (nasal,
nasopharyngeal, and oropharyngeal swabs) and for the at-home
testing service through Picture Genetics. 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.
About Picture Genetics
Through its Picture Genetics platform launched in 2019, Fulgent
Genetics offers consumers direct access to its advanced genetic
testing and analytics capabilities from the ease and comfort of
home, at an affordable price point. The Picture Genetics platform
provides a holistic approach to at-home genetic screening by
including oversight from independent physicians as well as genetic
counseling options to complement Fulgent Genetics’ comprehensive
genetic testing analysis. The Picture Genetics platform currently
offers multiple tests, providing 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: management’s
estimates and projections regarding testing trends during the
remainder of the pandemic, the suitability and performance of
RT-PCR tests, including Fulgent Genetics’ RT-PCR testing solution,
as compared to other potential testing solutions and for certain
testing circumstances, the company’s identification and evaluation
of opportunities and its ability to capitalize on opportunities to
grow its business; expected future lab capacity and turnaround
times; expectations or guidance regarding future revenues and
management’s judgements and evaluations of the company’s platform
and technology.
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 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 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 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, 2019 filed with the SEC on
March 13, 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
SEC. 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,
415-828-8298, jeff@blueshirtgroup.com
Fulgent Genetics (NASDAQ:FLGT)
Historical Stock Chart
From Mar 2024 to Apr 2024
Fulgent Genetics (NASDAQ:FLGT)
Historical Stock Chart
From Apr 2023 to Apr 2024