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The OraSure Family of Companies

Understanding human (and animal) health is more than reading a test result. It's diagnosing disease. It's linking patients to precise care. It's unlocking the stories that our DNA can tell. It's an inside-out and outside-in view of the trillions of bacteria and other microorganisms that make up the microbiome.

The OraSure family of companies delivers the innovative solutions and services backed by science that our customers need to solve the world’s greatest health and wellness challenges. We seek out and tackle our customers’ most complex problems head-on and give them access to actionable and insightful information. Whether that’s developing new sampling and data analysis methods, or creating new ways to diagnose and link patients to critical treatments and support — we are committed to finding new routes of discovery.

Our legacy lies in developing and delivering game-changing, innovative sampling tools, services and diagnostics designed to help our customers and partners get the best answers to their most critical questions, more easily and with more illuminating insights.

Diagnostics & Testing

We are committed to solving the world’s most complex testing challenges. Our legacy of innovation includes first-to-market rapid diagnostics for HIV, Hepatitis C and Ebola, as well as oral fluid laboratory tests for detecting various drugs of abuse. View Diagnostics & Testing Products »

Sampling Tools

We develop easy-to-use and reliable biological sample collection and stabilization devices. Our products maximize sample quality to ensure the highest integrity, from initial collection through downstream analysis. View Sampling Tools »

Services & Analysis

We accelerate the microbiome industry toward breakthrough discoveries through our innovative and accurate lab services, augmented by state-of-the-art data analytics and reporting. View Services & Analysis »

COVID-19

Since its inception in 2000, OraSure Technologies has been a leading innovator in diagnostic technologies. We are leveraging our expertise in infectious disease and molecular sample collection to advance three distinct COVID-19 testing solutions that feature convenient, pain-free self-collection, and help improve access to testing, alleviate the burden on the healthcare system, minimize exposure risks, and conserve PPE.

Molecular sample collection devices made by our DNA Genotek subsidiary are widely used in lab-based COVID-19 molecular tests. They have been included in multiple customer Emergency Use Authorizations (EUAs) held by a range of laboratories facilitating non-invasive collection of saliva samples for COVID-19 tests. We have also received our own FDA EUAs for the use of our OMNIgene®•ORAL and ORAcollect®•RNA collection devices in COVID-19 testing, which allow for the unsupervised use of these devices at home or in healthcare settings when used as part of an approved or validated at-home COVID-19 test kit.

OraSure has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its COVID-19 rapid antigen tests, which the Company is branding as InteliSwab™. The FDA has authorized the InteliSwab™ COVID-19 Rapid Test for Over-the-Counter (OTC) use without a prescription. FDA has also authorized the InteliSwab™ COVID-19 Rapid Test Pro for professional use in point of care (POC) CLIA-waived settings, and InteliSwab™ COVID-19 Rapid Test Rx for Prescription Home Use. These remarkably simple COVID-19 lateral flow tests use samples self-collected from the lower nostrils. InteliSwab’s unique design incorporates a built-in swab fully integrated into the test stick. After users swab their lower nostrils, the test stick is swirled in a pre-measured buffer solution, and the result appears right on the test stick within 30 minutes, with no instruments, batteries, smartphone or laboratory analysis needed to see the result.

OraSure is also working to secure EUA for its lab-based OraSure SARS-CoV-2 Antibody ELISA using oral fluid as a sample. Currently no COVID-19 antibody tests that use oral fluid samples have received EUA. This lab-based antibody test can aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating prior infection. Antibody tests are well suited for community surveillance and seroprevalence studies to identify people who have antibodies against COVID-19.