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OraSure Files Emergency Use Application For COVID-19 Kits For Home Use And Professional Test


OraSure Technologies Inc (NASDAQ: OSURhas submitted an application to the FDA seeking Emergency Use Authorization (EUA) for its COVID-19 rapid antigen test for both Prescription Home Use and Professional Use in point of care (POC) settings.

  • These lateral flow, rapid diagnostic tests are designed to detect active COVID-19 infection, using samples self-collected from the lower nostrils.
  • After users swab their lower nostrils, the test stick is swirled in a pre-measured buffer solution. No instrumentation, batteries, smartphone, or laboratory analysis is needed to read the result.
  • The company OraSure has started manufacturing the COVID-19 rapid antigen test in parallel with EUA submission.
  • It has well-established manufacturing capabilities, producing over 80 million rapid HIV, HCV, and Ebola tests.
  • OraSure is working on manufacturing capacity expansion that will bring annual capacity for its rapid tests from 55 million tests at the end of the first quarter to 70 million tests beginning in the third quarter of 2021 and further to 120 million units per year by the second quarter of 2022. 
  • Price Action: OSUR shares are up 3.46% higher at $11.36 in the premarket on the last check Tuesday.

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Posted-In: COVID-19 Coronavirus Emergency Use AuthorizationBiotech News Health Care Small Cap FDA General

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