a TGA approved Class 4 Self-Test in Australia, listed as the...

a TGA approved Class 4 Self-Test in Australia, listed as the ‘Atomo HIV Self-Test’ on the

ARTG.

In Atomo’s opinion, if it is successful in obtaining the required regulatory approvals in each of

the exclusive markets and securing commercial sales arrangements, the potential revenue

and earnings generated will be material.

As CE Marking is an internationally recognised quality standard for medical devices, Atomo

believes that approaching regulators in South-East Asia with the CE Marking of the

AtomoRapid™ COVID-19 (IgG/IgM) test in place, is likely to assist with the regulatory

process, particularly in Hong Kong, Taiwan and the Philippines. Atomo further believes that

the regulatory requirements in each of the South-East Asian and New Zealand markets will

be no more onerous than the CE Marking and TGA approval processes. All approvals

sought by Atomo for the AtomoRapid™ COVID-19 (IgG/IgM) test will be limited to

professional use only.

Atomo has made an application to the TGA for a Conformity Assessment Certificate for the

AtomoRapidTM COVID-19 (IgG/IgM) test. The approval sought is limited to professional use

only, and subject to TGA approval, the test will be added to Atomo’s existing ARTG listing.

The Peter Doherty Institute for Infection and Immunity (Doherty Institute) has been

engaged by the Department of Health to assist with the post-market validation of new

COVID-19 rapid tests to inform their best use and Atomo has committed to the submission of

its product for assessment by the Doherty Institute upon listing on the ARTG.

Now that Atomo has secured exclusive distribution rights, Atomo will progress regulatory

applications within its exclusive jurisdictions in the coming months and will keep the market

informed of its progress. Based on an assessment of regulatory pathways, Atomo’s initial

focus will be Australia, the Philippines, Hong Kong and Taiwan.

Atomo’s co-founder and Managing Director John Kelly said, “Atomo is delighted to have

secured exclusive rights to market, as the listed manufacturer, the COVID19 test which NG

Biotech has successfully launched in Europe with initial sales to the French Ministry of the

Armies (Defence) and a number of public hospitals, following strong results in independe