Where are you getting information that LDX's CovidX is a self test? The website says:
CoviDx™ SARS-CoV-2 Rapid Antigen Test is a lateral flow assay intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasal swabs and nasopharyngeal swabs from patients suspected of a Coronavirus-19 (COVID-19) infection by their healthcare provider within the first 5 days of symptoms.1
I hope they provide more information on sales to Europe for the products, all they have said so far was in the annual report where they state:
Lumos’ CoviDx SARS-CoV-2 Rapid Antigen Test detects antigens
present on the COVID-19 virus from a nasal swab of patients
suspected of having COVID-19. Through the rapid detection of
SARS-CoV-2, CoviDx is designed to optimise patient isolation
decisions and help prevent the spread of infection. This
product has CE Mark in Europe with initial sales in Italy. In
addition, it has been submitted to the FDA for Emergency Use
Authorization (EUA) in the U.S. and to Health Canada for Interim
Order authorisation.
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- Ann: Victorian Government Intent for Lumos Manufacturing Hub
Ann: Victorian Government Intent for Lumos Manufacturing Hub, page-16
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