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In Development

COVID-19

OraSure has been awarded a $710,310 contract from the Biomedical Advanced Research and Development Authority (BARDA), part of the Department of Health and Human Services (HHS), to develop a pan-SARS-coronavirus antigen rapid in-home self-test that uses oral fluid samples, the Company announced on April 6, 2020. This support from BARDA will enable OraSure to file for FDA Emergency Use Authorization (EUA) allowing for an in-home self-test to debut into the U.S. market. Built on OraSure’s OraQuick® platform, the rapid test would allow for in-home self-testing by lay users as well as by medical professionals. OraSure’s portable rapid test platform uses an oral fluid sample and provides results in 20 minutes. No instrumentation or trained personnel would be needed to administer the test or to read the results. OraSure has a well-documented history of success with in-home infectious disease testing; the Company’s oral fluid self-test for HIV has been used to diagnose millions of people around the world and connect them to life-saving care.

OraSure envisions a rapid development cycle of approximately 4-6 months prior to seeking Emergency Use Authorization (EUA).

“Lives and global economies are at stake. It’s crucial that we understand just how many people are infected with SARS-coronavirus,” said OraSure President and Chief Executive Officer Stephen S. Tang, Ph.D. “In-home self-testing will dramatically increase the capacity for SARS-coronavirus testing and give our healthcare systems and labs some much-needed breathing room. We believe that the development of an easy-to-use device that delivers accurate results to individuals in their homes can play a significant role in impacting infection rates. We are proud to bring our expertise with quality, rapid, oral fluid self-tests to the battle against the COVID-19 pandemic.”

“We need to put tests into people’s hands to know their infection status and protect their loved ones. At BARDA, we are continually looking for transformative technologies to combat public health threats, and rapid at-home coronavirus testing would be a game-changer,” said BARDA Director Rick Bright, Ph.D. “We know that people can spread COVID-19 without showing any symptoms, and with rapid at-home testing people could take immediate action to prevent the spread of the virus.”

The pan-SARS-coronavirus antigen rapid in-home self-test project has been funded in whole or in part with Federal funds from the Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. 75A50120C00061.

More details can be found here: Full Press Release

OraSure Technologies, Inc.