Lumos Diagnostics announced that it has completed all the development, verification and validation activities to support regulatory submissions for ViraDx, a three-in-one COVID-19/Flu A/Flu B rapid antigen test. Regulatory submissions are underway in the U.S. and Canada where ViraDx falls into a category that is prioritized for regulatory reviews. ViraDx is a 15-minute, three-in-one COVID-19/Flu A/Flu B rapid antigen test for use by qualified healthcare professionals to assess patients with acute respiratory symptoms. Following necessary regulatory authorizations, ViraDx may complement Lumos' FebriDx test. FebriDx is an all-in-one, 10-minute test that measures a patient's immune response to acute respiratory infections (ARIs) using a patented dual biomarker technology ­ without any additional instruments or equipment. When used as part of a clinical exam, FebriDx helps healthcare professionals manage patients with a wide range of acute respiratory symptoms such as sore throat, acute cough and sinus congestion. For bacterial infections, FebriDx provides a 99% negative predictive value (NPV), allowing healthcare professionals to confidently rule out bacterial infections for their patients. The ability to rule out bacterial infection is especially important during the respiratory (cold and flu) season because it can help reduce the use of medically unnecessary antibiotics. FebriDx is manufactured in the U.S. in ISO 13485 and MDSA-certified facilities. FebriDx is under review with the U.S. FDA and not cleared for use in the U.S.