OraSure Technologies
OraSure Technologies Gets FDA Emergency Use Authorization for Home-Use COVID-19 Antigen Tests
The firm said that its InteliSwab point-of-care antigen tests have received FDA authorization for over-the-counter, professional, and prescription use.
In Brief This Week: PerkinElmer, OraSure Technologies, LabCorp, Molzym, UniLabs, and More
News items for the in vitro diagnostics industry for the week of May 10, 2021.
OraSure Technologies Q1 Revenues Jump 85 Percent
The firm announced that it has submitted a COVID-19 antigen test for Emergency Use Authorization review by the US Food and Drug Administration.
FDA has signaled via public comments that it is flexible on test performance specs, but firms remain wary of falling short of official agency requirements.
After nearly a year in development, the firm's rapid antigen test will be submitted by the end of March for a prescription-use claim.
Dec 3, 2020
Will US Ever Get to Mass Testing for COVID-19?
Nov 4, 2020
OraSure Q3 Revenues Jump 33 Percent
Aug 7, 2020