2020

Dec 23

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• OraSure’s OMNIgene®·ORAL Device Included in EUA Amendment Granted to 3B BlackBio Biotech India for SARS-CoV-2 Test

  OTTAWA, ON, December 23, 2020 – 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 OMNIgene®·ORAL (OM/OME-505) collection device was included in the U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) amendment granted to 3B BlackBio Biotech, one of the leading suppliers and developers for RT-PCR diagnostic assays in India. This is the seventh customer EUA that includes a collection device from the company’s DNA Genotek subsidiary.

Nov 03

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• OraSure’s DNA Genotek Subsidiary Receives FDA Emergency Use Authorization for its ORAcollect®·RNA Saliva Collection Device for SARS CoV-2

  BETHLEHEM, PA, November 3, 2020 - 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 the ORAcollect®·RNA (OR/ORE-100) saliva collection device for the collection, stabilization and transport of saliva specimens suspected of containing SARS-CoV-2 RNA. This is the second FDA EUA that DNA Genotek has received for its saliva collection devices.

Sep 24

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• OraSure’s ORAcollect®·RNA Device Included in EUA Granted to Quadrant Biosciences Inc. for COVID-19 Test

  BETHLEHEM, Pa., September 24, 2020 - 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 ORAcollect®·RNA (OR-100) saliva collection device has been included in the U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) granted to Quadrant Biosciences Inc. for a COVID-19 laboratory test.

Sep 15

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• Former CEO of H2O+ Beauty, Former Chief Chemist of MAC Cosmetics Launch Innovative Skincare Brand Using First-Ever Scientific Microbiome Testing

  Pure Culture Beauty has partnered with DNA Genotek and Diversigen, the leading providers of high-quality biological sample collection products and end-to-end services for genomics and microbiome applications. DNA Genotek will supply the OMNIgene·SKIN microbiome collection kits and Diversigen will provide full microbiome analysis services, offering a complete understanding of the users’ skin microbiome. DNA Genotek and Diversigen are wholly owned subsidiaries of OraSure Technologies, Inc. (NASDAQ: OSUR).

Sep 03

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• OraSure’s ORAcollect®·RNA Device Included in EUA Granted to MiraDx Inc. for SARS-CoV-2 Test

  BETHLEHEM, PA -- September 3, 2020 - 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 ORAcollect®·RNA (OR-100) collection device was included along with other devices in the U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) granted to MiraDx Inc., a Los Angeles-based molecular genetics company. This is the fifth EUA to include a collection device from the company’s DNA Genotek subsidiary.

July 31

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• OraSure’s OMNIgene®·ORAL Device Included in EUA Granted to Clinical Reference Laboratory for Self-Collected SARS-CoV-2 Saliva Test

  BETHLEHEM, PA, July 31, 2020 - 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 OMNIgene®·ORAL (OM-505) saliva collection device is included in the U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) granted to Clinical Reference Laboratory (CRL), one of the largest privately held clinical testing laboratories in the United States, for SARS-CoV-2 testing. This is the fourth EUA to include a collection device manufactured and sold by the Company’s DNA Genotek subsidiary.

June 17

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• DNA Genotek unveils first in-home self-collection device for Metabolomics

  OTTAWA, ON, June 17, 2020 - OraSure Technologies, Inc. (NASDAQ: OSUR), a leader in point-of-care diagnostic tests, specimen collection devices, and microbiome laboratory and analytical services is introducing the first and only commercially available device for in-home, self-collection of fecal samples for metabolomics. A product of OraSure’s DNA Genotek subsidiary, the OMNImet™·GUT (ME-200) augments the Company’s portfolio of multiomic sample collection products. The device is intended for research use only.

June 08

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• Oragene^®·Dx included in EUA allowing at-home saliva collection for Phosphorus SARS-CoV-2 test

  OTTAWA, ON, June 8, 2020 - OraSure Technologies, Inc. (NASDAQ: OSUR), a leader in point-of-care diagnostic tests, specimen collection devices, and microbiome laboratory and analytical services, announced today that Phosphorus Diagnostics, a leader in diagnostic and bioinformatic solutions for clinical next generation sequencing (NGS)

May 22

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• OraSure’s OMNIgene^®·ORAL kit included in EUA granted to P23 Labs for at-home collection of saliva samples for SARS-CoV-2 test

  OTTAWA, ON, May 22, 2020 - OraSure Technologies, Inc. (NASDAQ: OSUR), a leader in point-of-care diagnostic tests, specimen collection devices, and microbiome laboratory and analytical services, (NASDAQ: OSUR), announced today that its OMNIgene®·ORAL saliva collection device (OM-505) was included in the U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) recently granted to P23 Labs. This EUA permits individuals to self-collect saliva specimens at-home for the detection of SARS-CoV-2.

May 04

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• DNA Genotek's ORAcollect^®·RNA kit included in EUA granted to Biocerna SARS-CoV-2 test

  OTTAWA, ON, May 4, 2020 - DNA Genotek Inc., a leading provider of sample collection kits and end-to-end services and a wholly-owned subsidiary of OraSure Technologies, Inc. (NASDAQ: OSUR), announced today that its ORAcollect®·RNA kit (OR-100) was included as the collection device for anterior nares (nasal) samples under a U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA)granted to Biocerna LLC for its PCR-based SARS-CoV-2 assay.

January 22

DNA Genotek Announces FDA General Use Clearance for Oragene®·Dx Family of Products

OTTAWA, ON, January 22, 2020 - DNA Genotek Inc., a leading provider of sample collection kits and end-to-end services and a wholly-owned subsidiary of OraSure Technologies, Inc. (NASDAQ: OSUR), announced today that the U.S. Food and Drug Administration (FDA) has granted a general use 510(k) clearance for its Oragene®•Dx family of products.