Aegirbio commences FDA fast track process with the Company's COVID-19 test
Aegirbio's U.S. team has reviewed the U.S. Food and Drug Administration's (FDA) requirements for marketing COVID-19 tests on the U.S. market. Building on the previous work undertaken to market the product in Europe, the Company is now ready to commence the FDA authorization process. Aegirbio's systematic effort to document the Company's COVID-19 tests for a launch in Europe under the CE-IVD Directive is thus expanded, as the request for Emergency Use Authorization (EUA) is submitted in the United States.The Company has further decided to invest in additional production capacity, expecting