OraSure Subsidiary DNA Genotek’s OMNIgene®·ORAL Saliva Collection Device Receives Health Canada Authorization for use in COVID-19 Testing
OraSure Technologies, Inc. (NASDAQ: OSUR) announced that its OMNIgene®·ORAL (OME-505) saliva collection device has received authorization from Health Canada for use in molecular diagnostic tests to detect SARS-CoV-2. This approval allows broader accessibility for COVID-19 testing, including at-home self-collection. The device is non-invasive, easing the testing process compared to traditional methods. In addition, OMNIgene®·ORAL has Emergency Use Authorization from the FDA and CE marking for use in the EU.
- Authorization from Health Canada expands the market for OMNIgene®·ORAL, potentially increasing revenue.
- Non-invasive saliva collection could enhance patient compliance for COVID-19 testing.
- The device has received emergency use authorization from the FDA, indicating regulatory confidence.
- None.
OTTAWA, Jan. 28, 2021 (GLOBE NEWSWIRE) -- OraSure Technologies, Inc. (NASDAQ: OSUR), a leader in point-of-care diagnostic tests, specimen collection devices, and microbiome laboratory and analytical services, today announced its OMNIgene®·ORAL (OME-505) saliva collection device, a product of Ottawa-based subsidiary DNA Genotek, has received authorization from Health Canada for use as a component in molecular diagnostic tests for the detection of SARS-CoV-2. Diagnostic labs, provincial and territory health authorities and COVID-19 test kit providers in Canada now have access to a non-invasive and painless saliva collection device to facilitate expansion of their COVID-19 testing programs.
Health Canada’s Interim Order authorization of OMNIgene®·ORAL (OME-505) will permit diagnostic labs, provincial and territory health authorities and COVID-19 test kit providers to offer testing more broadly, including for both at-home self-collection and via healthcare professionals. Those adding saliva to their workflow must validate the use of the OMNIgene®•ORAL with their assay prior to SARS-CoV-2 testing in accordance with applicable regulations.
“Widespread testing for COVID-19 is likely to occur for the foreseeable future, with periods of intense testing required to respond to the local outbreaks that will inevitably arise,” said Kathleen Weber, Executive Vice-President, Business Unit Leader, Molecular Solutions at DNA Genotek. “Providing labs, health units and test kit providers with technology like saliva collection for use at home or supervised by healthcare providers is critical in the fight against COVID-19. This authorization could be transformative for public health efforts in Canada and is an important tool to increase access to testing. As an Ottawa-based company, we are proud that this is now available to help combat the pandemic in Canada and we look forward to working with testing facilities to add our collection kit to their test offerings.”
Self-collected saliva is painless, non-invasive, and can be accessible to everyone unlike nasopharyngeal swabs which require supervision by a healthcare provider. Saliva-based collection is a cornerstone of containing the COVID-19 pandemic, to help identify cases and prevent new outbreaks from emerging.
In addition to this authorization from Health Canada, OMNIgene®·ORAL (OME-505) also has Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration and has CE marking for in vitro diagnostic use, including for use in COVID-19 testing, in the European Union.
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.
About DNA Genotek
DNA Genotek Inc., a subsidiary of OraSure Technologies, Inc., focuses 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 Use Only products to collect and preserve large amounts of DNA or RNA from multiple 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.
Important Information
This press release contains certain forward-looking statements, including with respect to expected revenues and earnings/loss per share. 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: ability to successfully manage and integrate acquisitions of other companies in a manner that complements or leverages our existing business, or otherwise expands or enhances our portfolio of products and our end-to-end service offerings, and the diversion of management’s attention from our ongoing business and regular business responsibilities to effect such integration; the expected economic benefits of acquisitions (and increased returns for our stockholders), including that the anticipated synergies, revenue enhancement strategies and other benefits from the acquisitions may not be fully realized or may take longer to realize than expected and our actual integration costs may exceed our estimates; impact of increased or different risks arising from the acquisition of companies located in foreign countries; 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 our business and our ability to successfully develop new products, validate the expanded use of existing collector products 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; ability to identify, complete, integrate and realize the full benefits of future acquisitions; 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, 2019, Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, 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: |
| Sam Martin | Jeanne Mell |
| Argot Partners | OraSure Technologies |
| 212-600-1902 | 484-353-1575 |
| orasure@argotpartners.com | media@orasure.com |
FAQ
What is the significance of OMNIgene®·ORAL (OME-505) receiving Health Canada authorization?
How does OMNIgene®·ORAL (OME-505) improve COVID-19 testing?
Has OMNIgene®·ORAL (OME-505) been authorized elsewhere?
