Home testing currently for TGA, CE and FDA is not regulatory permitted as consumers are error prone with these tests. Currently testing is conducted by a clinician, for data reliability and reporting. However Atomo is the first to have the regulatory approval medical device for home testing via their HIV test.
There is no supply and significant pent up demand for the supply of these RDT test kits. Also the significant bigger opportunity is if regulatory policy is relaxed around the world for RDT home testing for COvid19 , this opens up a very significant market for Atomo as they are one of the leaders in their field.
COVID-19, page-251
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