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  • Inside DNA Genotek → Press Releases → 2021

    Press Releases

    2021

    Jan 29

    • ORAcollect®·RNA (OR-100)
    • OraSure Subsidiary DNA Genotek’s OMNIgene·ORAL Included in EUA Granted to Ambry Genetics for Use in COVID-19 RT-PCR Saliva Test

      BETHLEHEM, PA, January 29, 2021 - 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 (OM-505) saliva collection kit, a product of subsidiary DNA Genotek, was included in the Emergency Use Authorization (EUA) granted to Ambry Genetics for use in its Ambry COVID-19 RT-PCR saliva test. OMNIgene·ORAL will be utilized for non-invasive and self-administered collection and stabilization of saliva for the detection and identification SARS CoV-2 RNA. This is the eighth EUA to include a collection device from the Company’s DNA Genotek subsidiary.

    Jan 28

    • ORAcollect®·RNA (OR-100)
    • OraSure Subsidiary DNA Genotek’s OMNIgene·ORAL Saliva Collection Device Receives Health Canada Authorization for use in COVID-19 Testing

      OTTAWA, ON, January 28, 2021 - 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.

    Jan 26

    • ORAcollect®·RNA (OR-100)
    • OraSure's Oragene®·ORAL Saliva Collection Kit Selected by Chronomics for Use in UK Government “Test to Release for International Travel” COVID-19 Testing Program

      BETHLEHEM, PA, January 26, 2021 - OraSure Technologies, Inc. (NASDAQ: OSUR), a leader in point-of-care diagnostic tests, specimen collection devices, and microbiome laboratory and analytical services, today announced that Chronomics Limited has selected the OMNIgene®·ORAL (OME-505) saliva collection device as a component of its SARS CoV-2 PCR test. Chronomics Limited will supply its test for the United Kingdom’s “Test to Release for International Travel” program. The OMNIgene®·ORAL device is a product of OraSure’s DNA Genotek subsidiary.

    Jan 21

    • ORAcollect®·RNA (OR-100)
    • OraSure's Oragene®·Dx Saliva Collection Kit Included in Industry's First FDA Authorization for a Whole Exome Sequencing Platform

      BETHLEHEM, PA, January 21, 2021 - OraSure Technologies, Inc. (NASDAQ: OSUR), a leader in point-of-care diagnostic tests, specimen collection devices, and microbiome laboratory and analytical services, today announced that its Oragene®·Dx (OGD-610) saliva collection device was included as a component in the De Novo authorization granted by the U.S. Food & Drug Administration (FDA) to Helix for their Helix® Laboratory Platform1, a whole exome sequencing platform. This is the first exome sequencing-based platform authorized by the FDA. Oragene·Dx is a product of OraSure's DNA Genotek subsidiary.

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    DNA Genotek Inc., a subsidiary of OraSure Technologies, Inc. (NASDAQ: OSUR), focuses on providing high-quality biological sample collection products and end-to-end services for human genomics, microbiome and infectious disease 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.

    © 2025 DNA Genotek Inc., a subsidiary of OraSure Technologies, Inc., all rights reserved.

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