OraSure Technologies, Inc. Expands HIV Oral Swab In-home Test into Europe
25 Gennaio 2022 - 1:05PM
OraSure Technologies, Inc. (NASDAQ: OSUR), a global leader in
point-of-care and home diagnostic testing and sample collection
technologies, announced today that it has launched its OraQuick®
HIV Self-Test, an oral swab in-home test for HIV-1 and HIV-2, into
Europe. The test will be available in six European countries:
United Kingdom, Germany, France, Italy, Spain and Portugal.
“We are currently seeing an increase in HIV testing policies, as
well as the rise of HIV prevalence around the globe,” said Giffin
Daughtridge, MD, MBA, Senior Director of Infectious Disease
Diagnostics for OraSure Technologies, Inc. “Having initially
launched in the U.S. in 2012, we focused on regions in need during
the last decade, distributing 76 million tests worldwide, many of
which were in Sub-Saharan Africa. We’re now expanding into European
countries to give people there more choice and access to HIV self
testing.”
OraQuick® is the world’s first in-home oral HIV Test. Unlike
other HIV self tests, it does not require a finger-prick blood
sample. It is a CE-marked, pain-free HIV test that is simple to
use, requiring a swipe of the upper gum and lower gum which
collects HIV antibodies in oral fluid. The OraQuick HIV Self-Test
uses these non-infectious HIV antibodies to detect the presence of
HIV. The easy-to-read results are ready in just 20 minutes, with
greater than 99 percent accuracy.
“Knowing your HIV status is the first step in helping people to
make informed choices and assume responsibility for their own
healthcare,” Daughtridge said. “If HIV is detected early and
virally suppressed, the virus can’t be passed on – meaning together
with education, access to therapeutics, and comprehensive clinical
support, we have the tools to end this epidemic.”
The test will be widely available at pharmacies throughout the
six European countries.
About OraSure
TechnologiesOraSure Technologies empowers the global
community to improve health and wellness by providing access to
accurate, essential information. OraSure, together with its
wholly-owned subsidiaries, DNA Genotek, Diversigen, and Novosanis,
provides its customers with end-to-end solutions that
encompass tools, services and diagnostics. The OraSure family
of companies is a leader in the development, manufacture, and
distribution of rapid diagnostic tests, sample collection and
stabilization devices, and molecular services solutions 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, pharma, commercial entities and direct to consumers. For
more information on OraSure Technologies, please visit
www.orasure.com.
Important Information
This press release contains certain
forward-looking statements, including with respect to products,
product development activities, regulatory submissions and
authorizations and other matters. 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: risk that the Company’s
exploration of strategic alternatives may not result in any
definitive transaction or enhance stockholder value and may create
a distraction or uncertainty that may adversely affect operating
results, business or investor perceptions; the diversion of
management’s attention from the Company’s ongoing business and
regular business responsibilities due to the Company’s exploration
of strategic alternatives; ability to resolve the Company’s ongoing
manufacturing challenges and satisfy customer demand; ability to
market and sell products, whether through our internal, direct
sales force or third parties; impact of significant customer
concentration in the genomics business; failure of distributors or
other customers to meet purchase forecasts, historic purchase
levels or minimum purchase requirements for our products; ability
to manufacture products in accordance with applicable
specifications, performance standards and quality requirements;
ability to obtain, and timing and cost of obtaining, necessary
regulatory approvals for new products or new indications or
applications for existing products; ability to comply with
applicable regulatory requirements; ability to effectively resolve
warning letters, audit observations and other findings or comments
from the U.S. Food and Drug Administration (“FDA”) or other
regulators; the impact of the novel coronavirus (“COVID-19”)
pandemic on the Company’s business and ability to successfully
develop new products, validate the expanded use of existing
collector products, receive necessary regulatory approvals and
authorizations and commercialize such products for COVID-19
testing; changes in relationships, including disputes or
disagreements, with strategic partners or other parties and
reliance on strategic partners for the performance of critical
activities under collaborative arrangements; ability to meet
increased demand for the Company’s products; impact of replacing
distributors; inventory levels at distributors and other customers;
ability of the Company to achieve its financial and strategic
objectives and continue to increase its revenues, including the
ability to expand international sales; impact of competitors,
competing products and technology changes; reduction or deferral of
public funding available to customers; competition from new or
better technology or lower cost products; ability to develop,
commercialize and market new products; market acceptance of oral
fluid or urine testing, collection or other products; market
acceptance and uptake of microbiome informatics, microbial genetics
technology and related analytics services; 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 (“CDC”) or other agencies; ability to fund research and
development and other products and operations; ability to obtain
and maintain new or existing product distribution channels;
reliance on sole supply sources for critical products and
components; availability of related products produced by third
parties or products required for use of our products; impact of
contracting with the U.S. government; impact of negative economic
conditions; ability to maintain sustained profitability; ability to
utilize net operating loss carry forwards or other deferred tax
assets; volatility of the Company’s stock price; uncertainty
relating to patent protection and potential patent infringement
claims; uncertainty and costs of litigation relating to patents and
other intellectual property; availability of licenses to patents or
other technology; ability to enter into international manufacturing
agreements; obstacles to international marketing and manufacturing
of products; ability to sell products internationally, including
the impact of changes in international funding sources and testing
algorithms; adverse movements in foreign currency exchange rates;
loss or impairment of sources of capital; ability to attract and
retain qualified personnel; exposure to product liability and other
types of litigation; changes in international, federal or state
laws and regulations; customer consolidations and inventory
practices; equipment failures and ability to obtain needed raw
materials and components; the impact of terrorist attacks and civil
unrest; and general political, business and economic conditions.
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, 2020, 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:
Scott
Gleason
SVP Investor Relations & Corporate
Communications
484-425-0588 sgleason@orasure.com
Media Contact:Amy KochSr. Mgr. Corporate
Communications484-523-1815media@orasure.com
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