OraSure Technologies Receives Blanket Clearance for its ORAcollect®•Dx Device for Over-the-Counter (OTC) Use from the U.S. Food and Drug Administration (FDA)
FDA clearance obtained through partnership with Grifols to support alpha risk screening1– Antripsyn (Alpha-1) deficiency in the US adult population
BETHLEHEM, Pa., Nov. 03, 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 company received US FDA clearance for its ORAcollect®•Dx saliva collection device for over-the-counter (ie direct-to-consumer) use. The device had previously been cleared for prescription use by the FDA. ORAcollect®•Dx joins the Oragene®•Dx product line that previously received FDA blanket clearance for prescription and over-the-counter use. This new designation now allows ORAcollect®•Dx devices to be used by OraSure’s commercial partners and legally marketed with their therapeutics or devices in conjunction with their intended product use. The ORAcollect®•Dx and Oragene®•Dx devices are designed to be used by an adult at home, without the advice of a healthcare professional.
OraSure has received this designation through its partnership with Grifols to support screening for alpha1-antitrypsin (alpha-1) deficiency in individuals who may be at risk for alpha-1. Alpha-1 increases the risk of lung disorders in patients and it is estimated that approximately 3% of COPD patients have alpha-1. Starting Q2 2023, Grifols will offer the free AlphaID™ At Home Genetic Health Risk service, supporting alpha-1 screening, which uses the ORAcollect®•Dx device to help identify those at risk. According to the Centers for Disease Control, COPD affects more than 15 million people in the United States.
“This clearance represents a major milestone for OraSure as we work collaboratively with our business partners to increase access to healthcare,” said Kathleen Weber, President of Molecular Solutions for OraSure Technologies. “With the movement towards precision medicine, we increasingly see the need for genetic testing to support FDA-approved therapies as drugs become more specialized for targeted patient populations. This expanded designation now allows us to better support our customers and expands the potential for future indications with the ORAcollect®•Dx device.
“We look forward to working with an experienced partner like OraSure to expand access to alpha-1 testing and awareness,” said Antonio Martínez, president of Grifols Diagnostics.
About Genotek DNA
DNA Genotek Inc., a subsidiary of OraSure Technologies, Inc., is focused on providing high quality biological sample collection products and end-to-end services for human genomics and microbiome applications. The Company’s Oragene®•Dx and ORAcollect®•Dx product lines are the first and only FDA 510(k)-cleared saliva-based DNA collection devices for in vitro diagnostic use. DNA Genotek also offers research-only products for collecting and storing large amounts of DNA or RNA from several sample types. DNA Genotek markets its products worldwide and has a global customer base with thousands of customers in over 100 countries. For more information about DNA Genotek, visit www.dnagenotek.com.
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.
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 depreciation 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 documents. 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|
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