OraSure Technologies, Inc. Expands HIV Oral Swab In-home Test into Europe
OraSure Technologies (NASDAQ: OSUR) has launched its OraQuick® HIV Self-Test in Europe, expanding access to its in-home oral swab test for HIV-1 and HIV-2. Available in the UK, Germany, France, Italy, Spain, and Portugal, this CE-marked test requires no blood sample and offers results in just 20 minutes with over 99% accuracy. Since its U.S. debut in 2012, OraSure has distributed 76 million tests globally, focusing on areas with high HIV prevalence. The initiative aligns with increasing global testing policies and aims to enhance healthcare accessibility across Europe.
- Launch of OraQuick® HIV Self-Test in six European countries.
- Test offers a non-invasive, pain-free option for HIV testing.
- Results available in 20 minutes with over 99% accuracy.
- Continued global distribution of 76 million tests since 2012.
- No specific financial metrics or projections provided regarding European market impact.
BETHLEHEM, Pa., Jan. 25, 2022 (GLOBE NEWSWIRE) -- 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 Technologies
OraSure 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 Koch
Sr. Mgr. Corporate Communications
484-523-1815
media@orasure.com
FAQ
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