Fulgent Genetics Receives Laboratory Permit and Genetic Test Approval from New York State Department of Health
August 01 2019 - 4:15PM
Fulgent Genetics (NASDAQ: FLGT) (“Fulgent Genetics” or the
“company”), a provider of comprehensive genetic testing and Next
Generation Sequencing (NGS) solutions, today announced that the
company has received approval from the New York State Department of
Health (NYSDOH) to offer next generating sequencing in the state of
New York. The NYSDOH has issued to Fulgent Genetics a clinical
laboratory permit in the category Genetic Testing - Molecular.
Fulgent Genetics leverages a proprietary technology platform to
offer one of the most comprehensive genetic testing solutions in
the market, providing flexibility and customization on panels for
over 18,000 genes. Fulgent Genetics is now licensed to offer its
tests to physicians and patients across New York State.
The New York State Department of Health’s Clinical Laboratory
Evaluation Program (CLEP) regulates and oversees clinical
diagnostic laboratories that test biological specimens from New
York State residents. The CLEP seeks to ensure the accuracy and
reliability of test results in clinical laboratories located within
the state or that accept specimens from New York State
residents.
"We are very excited to have received approval from New York
State for our next generation sequencing capabilities," said Harry
Gao, Lab Director and Chief Scientific Officer of Fulgent Genetics.
"New York’s CLEP is known to have the most rigorous review process
and standards for laboratory developed tests, and we believe that
its licensure of our clinical laboratory reflects the high standard
of quality and precision of our genetic testing platform. The state
of New York is a large and untapped market for us, and we look
forward to the opportunity to improve patient care with actionable
genetic testing solutions for individuals across the state.”
About Fulgent Genetics
Fulgent Genetics is a technology company with a 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 allows it to offer a broad and
flexible test menu and to continually expand and improve its
proprietary genetic reference library, while maintaining accessible
pricing, high accuracy and competitive turnaround times. The
company believes its test menu 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: the precision,
quality and competitive characteristics of the company’s genetic
testing platform and menu, the size of and the company’s ability to
access the New York genetic testing market, and the potential for
the company’s tests to improve patient care and to facilitate
clinically actionable results.
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
capture a sizable share of the developing market for genetic
testing and compete successfully in this market, including its
ability to continue to develop new tests that are attractive to its
various customer markets 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 Securities and Exchange
Commission, including its quarterly report on Form 10-Q for the
quarter ended March 31, 2019 filed with the Securities and Exchange
Commission on May 10, 2019 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, as well as its results of operations
for the periods covered by the financial results included in this
press release.
Investor Relations Contacts:The Blueshirt GroupNicole Borsje
415-217-2633
nborsje@blueshirtgroup.com
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