OraSure’s OMNIgene®·ORAL Collection Device Receives FDA Emergency Use Authorization for SARS CoV-2
OraSure Technologies (NASDAQ: OSUR) announced that its subsidiary DNA Genotek received Emergency Use Authorization (EUA) from the FDA for its OMNIgene®·ORAL saliva collection device for COVID-19 testing. This marks a significant milestone as it allows unsupervised at-home sample collection. The device has already been CE marked for use in the EU. The company is scaling up manufacturing to meet growing demand and has reported success in various testing programs across educational institutions and pharmacies. This development is crucial given the anticipated 2.4 billion annual tests needed in the U.S.
- Receipt of FDA EUA for OMNIgene®·ORAL device, allowing unsupervised at-home collection.
- Device already CE marked for in vitro diagnostics in the EU.
- Growing use of collection kits in educational and back-to-work programs.
- Increased manufacturing scale to meet anticipated demand.
- None.
BETHLEHEM, Pa., Oct. 19, 2020 (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 DNA Genotek subsidiary has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the use of DNA Genotek’s OMNIgene®·ORAL (OM-505, OME-505) saliva collection and stabilization device in COVID-19 testing. This is the first FDA EUA that allows for the unsupervised use of the device at-home or in a healthcare setting when used as part of an approved or validated at-home test kit, meaning patients can safely collect their own sample, without the presence of a healthcare professional.
With this FDA authorization, OMNIgene®·ORAL devices can be used for the self-collection, transport and laboratory testing of saliva specimens suspected of containing SARS-CoV-2 ribonucleic acid (RNA). This EUA follows the CE marking of OMNIgene®·ORAL (OME-505) for in vitro diagnostic use, including for COVID-19 testing, in the European Union.
“Since the beginning of the pandemic, DNA Genotek has been committed to addressing this global health emergency, and we are pleased to be able to provide a robust solution for easy, safe sample collection that supports detection of this highly contagious virus,” said Kathleen Weber, Executive Vice President, Business Unit Leader, Molecular Solutions at DNA Genotek. “Laboratories and test providers in both the U.S. and European Union can benefit from having a device that collects RNA for SARS-CoV-2, as evidenced by it being both CE marked and FDA authorized.”
“Easy-to-use and reliable methods to detect SARS-CoV-2 are crucial to meet the massive need for testing which the Rockefeller Foundation estimates at 2.4 billion tests annually in the U.S. alone,” said Stephen S. Tang, Ph.D., OraSure President and Chief Executive Officer. “The DNA Genotek team quickly leveraged its innovative spirit and expertise with molecular sample collection to address this need with OMNIgene®·ORAL and the unsupervised, in-home sample collection that it supports when used as part of a validated at-home test kit.”
In addition to its device EUA, OraSure announced several other milestones related to the use of DNA Genotek’s collection devices for COVID-19 testing:
- Use of DNA Genotek collection kits continue to grow in back-to-work settings, back-to-school programs, and laboratory testing, including:
- 30,000 students tested at the University of Kansas before returning to campus, via Clinical Reference Laboratory;
- 64 State University of New York campuses testing students and employees, via Quadrant Biosciences;
- Test kits available at Albertsons Companies pharmacies throughout the U.S. via Phosphorus Diagnostics;
- Back-to-work programs integrating COVID-19 testing, monitoring, assessment and access to telemedicine visits for companies, through Azova, Inc.
- DNA Genotek has scaled up manufacturing of saliva collection devices to meet customer demand for COVID-19 testing, and plans to significantly increase capacity in the first quarter of 2021.
- The DNA Genotek kits for detection of the SARS-CoV-2 virus have been included in six customer EUAs. The OMNIgene®·ORAL device has been included in EUAs granted to Clinical Reference Laboratory (CRL) and P23. The OraCollect®·RNA device has been included in EUAs granted to Biocerna LLC, MiraDx and Quadrant Biosciences. The Oragene®·Dx device has been included in an EUA granted to Phosphorus Diagnostics.
- DNA Genotek’s devices support both PCR and sequencing-based COVID-19 tests, and its collection kits can be used for collection at home by consumers or by laboratory staff and healthcare providers.
About OraSure Technologies
OraSure Technologies empowers the global community to improve health and wellness by providing access to accurate, essential information. Together with its wholly-owned subsidiaries, DNA Genotek, Diversigen, CoreBiome (now operating under the Diversigen brand), UrSure and Novosanis, OraSure 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 June 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 | VP Corporate Communications |
| 212-602-1902 | 484-353-1575 |
| orasure@argotpartners.com | media@orasure.com |
FAQ
What is the significance of the FDA EUA for OraSure's OMNIgene®·ORAL device?
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