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OraSure Subsidiary DNA Genotek’s OMNIgene(R)– ORAL Saliva Assortment Product Gets Wellness Canada Authorization for use in COVID-19 Tests

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OTTAWA, Jan 28, 2021 (Globe NEWSWIRE by way of COMTEX) —
OTTAWA, Jan. 28, 2021 (Globe NEWSWIRE) — OraSure Technologies, Inc. (NASDAQ: OSUR), a leader in position-of-care diagnostic tests, specimen assortment gadgets, and microbiome laboratory and analytical products and services, nowadays announced its OMNIgene(R)— ORAL (OME-505) saliva collection system, a product or service of Ottawa-based mostly subsidiary DNA Genotek, has acquired authorization from Well being Canada for use as a part in molecular diagnostic checks for the detection of SARS-CoV-2. Diagnostic labs, provincial and territory health and fitness authorities and COVID-19 take a look at package companies in Canada now have obtain to a non-invasive and pain-free saliva selection device to aid enlargement of their COVID-19 screening plans.

Wellness Canada’s Interim Get authorization of OMNIgene(R)— ORAL (OME-505) will allow diagnostic labs, provincial and territory health and fitness authorities and COVID-19 test kit companies to offer you screening more broadly, including for each at-house self-selection and through healthcare specialists. These incorporating saliva to their workflow need to validate the use of the OMNIgene(R)?ORAL with their assay prior to SARS-CoV-2 screening in accordance with relevant regulations.

“Common testing for COVID-19 is most likely to come about for the foreseeable potential, with periods of intense testing required to answer to the local outbreaks that will inevitably occur,” stated Kathleen Weber, Govt Vice-President, Organization Unit Leader, Molecular Remedies at DNA Genotek. “Offering labs, health units and exam package companies with technology like saliva assortment for use at property or supervised by health care companies is crucial in the battle from COVID-19. This authorization could be transformative for public health attempts in Canada and is an significant instrument to maximize access to tests. As an Ottawa-centered enterprise, we are very pleased that this is now accessible to enable fight the pandemic in Canada and we glance ahead to functioning with screening facilities to add our selection kit to their exam offerings.”

Self-collected saliva is painless, non-invasive, and can be accessible to anyone not like nasopharyngeal swabs which demand supervision by a health care supplier. Saliva-dependent selection is a cornerstone of that contains the COVID-19 pandemic, to help establish circumstances and avert new outbreaks from emerging.

In addition to this authorization from Health and fitness Canada, OMNIgene(R)— ORAL (OME-505) also has Unexpected emergency Use Authorization (EUA) from the U.S. Foods and Drug Administration and has CE marking for in vitro diagnostic use, like for use in COVID-19 screening, in the European Union.

About OraSure Technologies

OraSure Technologies empowers the world-wide community to boost health and wellness by supplying entry to precise, essential facts. OraSure, alongside one another with its wholly-owned subsidiaries, DNA Genotek, Diversigen, and Novosanis, delivers its prospects with end-to-close solutions that encompass resources, solutions and diagnostics. The OraSure household of firms is a chief in the enhancement, manufacture, and distribution of swift diagnostic tests, sample collection and stabilization devices, and molecular expert services answers built to find and detect vital healthcare conditions. OraSure’s portfolio of solutions is bought globally to scientific laboratories, hospitals, physician’s places of work, clinics, public overall health and neighborhood-based mostly corporations, investigation establishments, government companies, pharma, industrial entities and direct to people. For much more data on OraSure Systems, make sure you go to www.orasure.com.

About DNA Genotek

DNA Genotek Inc., a subsidiary of OraSure Systems, Inc., focuses on giving higher-top quality organic sample collection solutions and close-to-conclusion companies for human genomics and microbiome programs. The Firm’s Oragene(R)?Dx and ORAcollect(R)?Dx solution strains are the first and only Food and drug administration 510(k) cleared saliva-based DNA collection devices for in vitro diagnostic use. DNA Genotek also gives Investigate Use Only items to obtain and protect massive amounts of DNA or RNA from multiple sample varieties. DNA Genotek markets its products and solutions throughout the world and has a world shopper base with hundreds of customers in over 100 international locations. For more information and facts about DNA Genotek, check out www.dnagenotek.com.

Essential Information

This push release includes particular ahead-seeking statements, which include with regard to anticipated revenues and earnings/decline per share. Forward-searching statements are not guarantees of future effectiveness or final results. Identified and unfamiliar factors that could induce genuine general performance or effects to be materially unique from individuals expressed or implied in these statements incorporate, but are not minimal to: means to effectively regulate and integrate acquisitions of other companies in a way that enhances or leverages our present enterprise, or usually expands or enhances our portfolio of goods and our end-to-close support choices, and the diversion of management’s awareness from our ongoing business and normal enterprise obligations to effect such integration the predicted economic added benefits of acquisitions (and enhanced returns for our stockholders), including that the expected synergies, revenue improvement methods and other benefits from the acquisitions may possibly not be absolutely recognized or may perhaps acquire extended to comprehend than anticipated and our real integration costs may exceed our estimates effects of amplified or distinct risks arising from the acquisition of organizations situated in international nations means to market place and provide items, irrespective of whether via our inside, direct profits power or third functions impression of major shopper concentration in the genomics business failure of distributors or other consumers to meet purchase forecasts, historic buy amounts or minimum amount obtain needs for our items means to manufacture merchandise in accordance with relevant specs, effectiveness specifications and excellent necessities capability to receive, and timing and value of getting, essential regulatory approvals for new merchandise or new indications or purposes for existing solutions means to comply with relevant regulatory demands ability to efficiently resolve warning letters, audit observations and other findings or remarks from the U.S. Food stuff and Drug Administration (“Food and drug administration”) or other regulators the influence of the novel coronavirus (“COVID-19”) pandemic on our business and our ability to productively develop new merchandise, validate the expanded use of current collector products and solutions and commercialize this sort of goods for COVID-19 tests modifications in interactions, which includes disputes or disagreements, with strategic associates or other get-togethers and reliance on strategic partners for the functionality of vital routines less than collaborative preparations potential to meet up with greater demand from customers for the Firm’s merchandise effects of changing distributors inventory concentrations at distributors and other clients capacity of the Enterprise to realize its fiscal and strategic targets and carry on to raise its revenues, which includes the ability to develop global product sales means to discover, finish, combine and recognize the full advantages of long term acquisitions effect of opponents, competing goods and technological innovation modifications reduction or deferral of community funding out there to customers opposition from new or superior know-how or reduced charge items potential to establish, commercialize and industry new products marketplace acceptance of oral fluid or urine tests, assortment or other products and solutions current market acceptance and uptake of microbiome informatics, microbial genetics engineering and relevant analytics companies variations in sector acceptance of products based mostly on product performance or other factors, like changes in testing recommendations, algorithms or other tips by the Facilities for Ailment Control and Prevention (“CDC”) or other businesses potential to fund investigation and progress and other products and functions potential to attain and sustain new or current solution distribution channels reliance on sole provide resources for crucial products and solutions and elements availability of relevant merchandise developed by 3rd parties or merchandise essential for use of our products effect of contracting with the U.S. authorities affect of detrimental economic conditions ability to sustain sustained profitability skill to benefit from web functioning loss carry forwards or other deferred tax property volatility of the Firm’s stock cost uncertainty relating to patent security and probable patent infringement statements uncertainty and fees of litigation relating to patents and other mental house availability of licenses to patents or other engineering means to enter into intercontinental producing agreements road blocks to worldwide advertising and marketing and producing of merchandise means to market products and solutions internationally, such as the effects of adjustments in international funding resources and testing algorithms adverse movements in foreign currency trade rates decline or impairment of resources of capital skill to entice and retain competent staff exposure to product legal responsibility and other styles of litigation adjustments in worldwide, federal or condition legislation and polices consumer consolidations and inventory practices devices failures and capacity to receive essential raw products and elements the effect of terrorist assaults and civil unrest and basic political, business enterprise and financial circumstances. These and other aspects that could impact our benefits are mentioned extra totally in our SEC filings, including our registration statements, Yearly Report on Sort 10-K for the calendar year finished December 31, 2019, Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, and other filings with the SEC. While forward-on the lookout statements enable to offer information about long term potential customers, viewers must preserve in intellect that forward-wanting statements could not be reliable. Readers are cautioned not to area undue reliance on the forward-hunting statements. The forward-on the lookout statements are built as of the day of this push release and OraSure Systems undertakes no duty to update these statements.


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