2021

Jan 29

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• 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

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• 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

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• 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

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• 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.