We have had multiple questions raised in recent days about the number of companies announcing various forms of tests for COVID-19. The trend has been towards blood-based tests for antibodies that identify if the subject has or has had the virus. The trend is also towards point of care tests to facilitate localised testing.
Virtually without exception the existing tests are either dependent on laboratory type equipment to assess the result, or they are mini "chemistry set" type tests, which require the measurement and addition of reagents to perform the test. With rare emergency exceptions, these 'chemistry set’ type tests are only for professional use, and are not typically approved by regulators for self-test use due to the risk of operator errors.
We can expect more news stories about different test methods, but it is important to note that Atomo isn't competing on the test method itself, but as a fully integrated blood-based device for both professional and self-testing.
Atomo can incorporate other company's lateral flow tests in their device, which has already been approved for self-tests for other applications, such as HIV testing. This approach is validated by the agreement with NG Biotech announced today.
Atomo’s RDT devices have been proven in the market through the development, regulatory approval and commercialisation of a range of blood based rapid test applications, including the Company’s own HIV Self-Test product which has received prequalification from the World Health Organisation, as well as securing approval by the Australian TGA and CE Mark for Europe. Atomo has been successful in the HIV test market where there are also many competing tests.
