OraQuick® HIV Self-Test Now Approved for Use in Adolescents
07 Gennaio 2025 - 1:05PM
OraQuick® HIV Self-Test that will increase access to HIV testing
for adolescents. The change expands the approved age range to
include individuals 14 years of age and older for the OraQuick® HIV
Self-Test. Previously the test was approved for use in those 17 and
older.
According to the most recent data available from the Centers for
Disease Control & Prevention, it is estimated that 19 percent
of new HIV diagnoses in the United States were among young people
aged 13 to 24, and only 6 percent of high school students have ever
been tested for HIV. Almost half of young people with HIV do not
know that they have it.
“Increasing access to different testing options is critical to
ending the HIV epidemic for all people, and early connection to
care is essential for adolescents who test positive for HIV,” said
Carrie Eglinton Manner, President and CEO of OraSure Technologies.
“We are pleased that our OraQuick® HIV Self-Test can now be used
within this younger population who needs it, and we are proud of
the work we have done to promote HIV testing, help people know
their HIV status, and stop the stigma of infection. This approval
will allow us to expand access to help those who need it.”
The OraQuick® HIV Self-Test has been available direct to
consumers in the U.S. since 2012. Since its launch, OraSure has
been committed to providing consumers with access to critical
information and connection to care. The packaging contains robust
educational material and linkage to care information, giving
individuals information that they can use to make informed
decisions, regardless of the test result.
About OraSure Technologies, Inc.OraSure
Technologies, Inc. (“OraSure”) transforms health through actionable
insight and powers the shift that connects people to healthcare
wherever they are. OraSure improves access, quality, and value of
healthcare with innovation in effortless tests and sample
management solutions. OraSure, together with its wholly-owned
subsidiaries, DNA Genotek Inc. and Sherlock Biosciences, Inc., is a
leader in the development, manufacture, and distribution of rapid
diagnostic tests and sample collection and stabilization devices
designed to discover and detect critical medical conditions.
OraSure’s portfolio of products is sold globally to clinical
laboratories, hospitals, physician’s offices, clinics, public
health and community-based organizations, research institutions,
government agencies, pharmaceutical companies, and direct to
consumers. For more information on OraSure Technologies, please
visit www.orasure.com.
Forward-Looking Statement This press release
contains certain forward-looking statements addressing
expectations, prospects, estimates and other matters that are
dependent upon future events or developments. These statements may
be identified by words such as "expect," "anticipate," "intend,"
"plan," "believe," "will," "should," "could," "would," "project,"
"continue," "likely," and similar expressions. Forward-looking
statements are not guarantees of future performance or results.
Known and unknown factors that could cause actual performance or
results to be materially different from those expressed or implied
in these statements include, but are not limited to: our ability to
satisfy customer demand; ability to market and sell products,
whether through our internal, direct sales force or third parties;
ability to manufacture or have manufactured products in accordance
with applicable specifications, performance standards and quality
requirements; ability to comply with applicable regulatory
requirements; ability to meet increased demand for OraSure’s
products; competition from new or better technology or lower cost
products; changes in market acceptance of products based on product
performance or other factors, including changes in testing
guidelines, algorithms or other recommendations by the Centers for
Disease Control and Prevention or other agencies; ability to obtain
and maintain new or existing product distribution channels; impact
of negative economic conditions; ability to maintain sustained
profitability; changes in international, federal or state laws and
regulations; equipment failures and ability to obtain needed raw
materials and components. These and other factors that could affect
our results are discussed more fully in our SEC filings, including
our registration statements, Annual Report on Form 10-K for the
year ended December 31, 2023, Quarterly Reports on Form 10-Q, and
other filings with the SEC. Although forward-looking statements
help to provide information about future prospects, readers should
keep in mind that forward-looking statements may not be reliable.
Readers are cautioned not to place undue reliance on the
forward-looking statements. The forward-looking statements are made
as of the date of this press release and OraSure Technologies
undertakes no duty to update these statements.
Investor Contact: |
Media Contact: |
Jason Plagman |
Amy Koch |
Vice President, Investor
Relations |
Director, Corporate
Communications |
investorinfo@orasure.com |
media@orasure.com |
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