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OraSure’s Oragene®•Dx included in EUA allowing at-home saliva collection for use with Phosphorus SARS-CoV-2 test
The number of EUAs utilizing OraSure’s saliva collection products continues to grow OTTAWA, June 08, 2020 (GLOBE NEWSWIRE) -- OraSure Technologies, Inc.
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[{"type":"text","content":"The number of EUAs utilizing OraSure’s saliva collection products continues to grow\nOTTAWA, June 08, 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, announced today that Phosphorus Diagnostics, a leader in diagnostic and bioinformatic solutions for clinical next generation sequencing (NGS), was granted an Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA) allowing individuals to self-collect saliva specimens with the Company’s Oragene®•Dx (OGD-510) collection kit for the detection of SARS-CoV-2 using the Phosphorus COVID-19 RT-qPCR test.\n The Phosphorus COVID-19 RT-qPCR test detects nucleic acid from SARS-CoV-2 in the saliva of individuals who are suspected of being infected with COVID-19 by a healthcare professional. Combined with the easy-to-use Oragene®•Dx (OGD-510) saliva collection device from OraSure’s subsidiary, DNA Genotek, this is an easily deployable testing option for patient or employee populations and for at-home use. Eligibility to receive an Oragene®•Dx collection device for in-home self-collection will be determined based on a medical questionnaire reviewed by a healthcare professional before shipment. This is the third EUA for SARS-CoV-2 testing that utilizes a DNA Genotek collection device and the first that allows a fully at-home, unsupervised collection solution utilizing a DNA Genotek device. Earlier this month, the Company’s ORAcollect®•RNA kit (OR-100) was included as the collection device for the EUA granted to Biocerna LLC. The Company’s OMNIgene®•ORAL (OM-505) was included in the EUA recently granted to P23 Labs. “DNA Genotek continues to find new ways to help patients and healthcare providers fight the COVID-19 crisis through our leading saliva-based collection devices,” said Kathleen Weber, Executive Vice President, Business Unit Leader, Molecular Solutions at DNA Genotek. “Our at-home collection kits are designed to make it easier and safer to self-collect samples during this important time. Working with the FDA, regulatory bodies around the world, and laboratories like Phosphorus, we are committed to expanding the availability of saliva-based collection devices to prevent the spread of this disease.” Alexander Bisignano, CEO ...