LDX Q1 FY22 report is out - some excerpts from it about FebriDx:
(news posted by Goldsu earlier) "Emergency Department (ED) at Box Hill Hospital, Melbourne Australia, initiated at 300-subject real-world clinical study using FebriDx to evaluate patients presenting to the ED with suspected COVID-19 infection."
".... FebriDx is currently being evaluated in 10 investigator-led post market studies, including both outcome and clinical validation studies, across Europe and Australia."
"The U.S. FDA is actively reviewing Lumos’ 510(k) application for FebriDx for the identification of patients with bacterial or viral acute respiratory infection. Lumos is expecting an outcome from this review process during FY22 which, if successful, will allow Lumos to commence sales and marketing activities in the U.S...."
"..is preparing to complete the development and file an application for its ViraDx™ test that combines the COVID-19 antigen testing with a rapid antigen test for influenza A/B. Lumos’ ViraDx test would specifically identify the leading ARI viral infections (COVID-19 and influenza), and potentially provide a natural follow-up test to a positive viral infection reading from FebriDx"
"...FebriDx U.S. commercialisation following U.S. FDA 510(k) clearance is anticipated in FY 2022 along with the follow-on publication of clinical trial results. In anticipation of this market access, Lumos will continue to build its U.S. commercial infrastucture, multispecialty medical advisory boards, specialty regional distribution partnerships, and solidify milestones to support Medicare and 3rd party reimbursement. Further, the ability to supply additional synergistic tests to FebriDx through existing sales channels, such as for CoviDx and ViraDx, will enhance market adoption"
