OraSure Technologies Receives $8.6M BARDA Contract to Develop 2nd Generation Ebola Test | New


BETHLEHEM, Pa., Sept. 28, 2022 (GLOBE NEWSWIRE) — OraSure Technologies, Inc. (NASDAQ: OSUR), a global leader in point-of-care and home specimen collection and diagnostic testing technologies, announced today that the Biomedical Advanced Research and Development Authority (BARDA) awarded the company an $8.6 million contract to develop a 2nd generation Ebola test on the OraQuick® test platform. The goal is for the 2nd generation test to have improved sensitivity, increased shelf life, new chemistry and more automation compared to the US Food and Drug Administration (FDA) cleared de novo test. OraSure’s OraQuick® Ebola Rapid Antigen test is the only test today with de novo clearance from the FDA and has been widely used for cadaver Ebola testing in Africa with results available in 30 minutes.

“We are proud to partner with BARDA to develop a 2nd generation Ebola test and help prevent the spread of a disease that affects some of our most vulnerable global communities,” said Lisa Nibauer, President of Diagnostics for OraSure Technologies. . “Whether it’s our response to the HIV epidemic, our work to counter the global COVID-19 pandemic, or this project, OraSure has increasingly partnered with the United States federal government. to counter some of the biggest public health challenges we face around the world. .”

OraSure’s current OraQuick® Ebola Rapid Antigen Test is cleared de novo for use with whole blood or cadaveric oral fluid. The test received de novo clearance from the FDA in 2019, making it the first and only rapid antigen test to receive clearance for the detection of Ebola virus.

This project was funded in whole or in part by federal funds from the Department of Health and Human Services; Administration of Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority, under contract no. 75A50122R00024.

About OraSure Technologies

OraSure Technologies enables the global community to improve health and well-being by providing access to accurate and essential information. OraSure, 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 service solutions designed to discover and detect critical medical conditions. OraSure’s product portfolio is sold worldwide to clinical laboratories, hospitals, medical practices, clinics, public health and community organizations, research institutes, government agencies, pharmaceutical companies, commercial entities and directly to consumers. For more information about OraSure Technologies, please visit www.orasure.com.

Important Information

This press release contains certain forward-looking statements, including with respect to the Company’s products, product development activities, regulatory submissions and clearances 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 differ materially from those expressed or implied by such statements include, but are not limited to: the risk that the Company’s exploration of strategic alternatives will not result in any definitive transaction or enhance shareholder value and may create distraction or uncertainty that could adversely affect results of operations, business or investor perception; the diversion of management’s attention from the company’s day-to-day operations and regular business responsibilities due to the company’s exploration of strategic alternatives; ability to solve the company’s ongoing manufacturing challenges and meet customer demand; ability to market and sell products, whether through our internal direct sales force or third parties; the impact of significant customer concentration in the genomics industry; failure of distributors or other customers to meet purchase forecasts, historical purchase levels or minimum purchase requirements for our products; ability to manufacture products in accordance with applicable specifications, performance standards and quality requirements; the ability to obtain, and the 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 United States Food and Drug Administration (“FDA”) or other regulatory agencies; the impact of the novel coronavirus (“COVID-19”) pandemic on the Company’s business and its ability to successfully develop new products, validate the expanded use of existing collection products, receive approvals and necessary regulatory authorizations and to market these products for COVID-19 testing; changes in relationships, including disputes or disagreements, with strategic partners or other parties and reliance on strategic partners to perform 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; the Company’s ability to achieve its financial and strategic objectives and to continue to increase its revenues, including the ability to expand its international sales; the impact of competitors, competing products and technological changes; reduction or postponement of public funding available to customers; competition from new or improved technologies or lower cost products; ability to develop, market and market new products; market acceptance of saliva or urine tests, swabs or other products; market acceptance and adoption of microbiome informatics, microbial genetics technology and related analytical 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 distribution channels for new or existing products; dependence on single sources of supply for critical products and components; the availability of related products manufactured by third parties or products necessary for the use of our products; the impact of US government contracts; impact of negative economic conditions; ability to maintain sustained profitability; ability to utilize net operating losses carried forward or other deferred tax assets; the volatility of the price of the Company’s shares; uncertainty relating to patent protection and potential patent infringement claims; the uncertainty and costs of litigation relating to patents and other intellectual property rights; availability of patent or other technology licenses; ability to enter into international manufacturing agreements; barriers 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 capital sources; 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 groupings and inventory practices; equipment failures and the ability to obtain necessary raw materials and components; the impact of terrorist attacks and civil unrest; and general political, commercial and economic conditions. These and other factors that could affect our results are discussed in more detail in our filings with the SEC, including our registration statements, our Annual Report on Form 10-K for the fiscal year ended December 31, 2021 , our quarterly reports on Form 10-Q and other filings. with the SEC. Although forward-looking statements help provide information about future prospects, readers should be aware that forward-looking statements may not be relied upon. Readers are cautioned not to place undue reliance on forward-looking statements. Forward-looking statements are made as of the date of this press release and OraSure Technologies undertakes no obligation to update such statements.

Investor contacts: Media Contact:
Scott Gleson Amy Koch
SVP Investor Relations and Corporate Communications Sr Msgr. Business communication
484-425-0588 484-523-1815
[email protected] [email protected]

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