Atomo Diagnostics (ASX: AT1) has cleared a major regulatory hurdle in the US for a rapid COVID-19 antibody test it helped develop after receiving emergency use authorisation (EUA) from the Food and Drug Administration (FDA).
The EUA means sales of the CareStart EZ COVID-19 test for use in point-of-care settings like doctors' offices, hospitals and emergency rooms in the US can commence.
Shares in Sydney-based Atomo have spiked as a result, up more than 37 per cent at the time of writing to $0.18 per share.
The medical device is a rapid antibody test made by combining an integrated device developed by Atomo and a rapid COVID-19 antibody test strip from South Korean company Access Bio.
It has been designed to identify individuals with an adaptive immune response to SARS-COV-2, indicating recent or prior infection.
"We are happy that our integrated test device has enabled Access Bio to secure EUA for point-of-care use for their COVID-19 antibody test and for it to be used in a broad range of non-laboratory settings in the US," says Atomo managing director John Kelly.
Access Bio CEO Young Ho Choi said the test will be useful in the US where nearly half of country's population has been vaccinated against COVID-19.
"As vaccinations are accelerating, the demand to check whether or not antibodies are produced is only increasing. Our rapid tests will be useful in doctor's offices and clinics in pharmacies with good accessibility," Choi said.
"As the possibility of a third vaccination is emerging as a prediction of the re-spreading of the coronavirus this fall, we expect that the antibody diagnosis will help in the determination of the need for a further booster vaccination."
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