One of the few ASX stocks involved in COVID-19 testing, Atomo Diagnostics (ASX:AT1), just obtained Emergency Use Authorisation from the FDA.

Atomo Diagnostics makes rapid COVID-19 tests (among other medical tests) one of which — CareStart EZ COVID-19 IgM/IgG — was developed with Korean listed company Access Bio.

CareStart is a blood test intended to identify recent or prior COVID-19 infections utilising Atomo’s platform.

The FDA has given CareStart Emergency Use Authorisation (EUA), essentially meaning it can be rolled out. While EUA has been obtained by other COVID-19 tests most have been restricted to lab use.

Atomo listed last April at a time markets were beginning to recover from the  COVID-19 crash.

Shares went as high as 52c last year but have been below the 20c IPO price for some weeks now as the vaccine roll out speeds up everywhere but in Australia.

Today, Atomo shares rose by as much as 50 per cent  making it one of the biggest winners and briefly taking it above its IPO price.

Atomo Diagnostics (ASX:AT1) share price chart


What is Emergency Use Authorisation?

EUA is not full approval, but requires less due diligence to get to market and is employed in times of medical emergencies in the US.

EUA was first employed when HIV/AIDs emerged and has been heavily utilised during the COVID-19 pandemic.

It is how all 3 COVID-19 vaccines in the US – Pfizer, Moderna and Johnson & Johnson – have been rolled out.

 Atomo has long argued vaccines wouldn’t take away the need for COVID-19 tests.

Atomo’s managing director John Kelly says there is uncertainty as to whether two vaccine jabs will be enough to provide long term protection.

“The official jury is still out on whether people need boosters, but I think the scientific consensus is they will,” he said.

“An accurate, easy to use test to see whether people had an robust antibody response or whether that antibody response has fallen away will be important for a number of years.”


What now for Atomo Diagnostics?

Kelly told Stockhead this was not the only thing his company was working on.

These included a separate agreement for a rapid antigen COVID-19 test and potentially applications outside COVID-19.

“The FDA approval opens up a lot of doors for registrations globally and we’re in discussions with Access Bio about that,” he said.

“And we’re also in discussions with Access Bio about a number of applications outside COVID.

“We did a deal with them for HIV which we’re looking to commercialise in partnership with them.

“They’ve a broad range of assays that they’re interested in possibly putting on our platform, now we’ve showed them we can get them extra approvals for use in home care settings that they couldn’t get with their standard offering.”