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Atomo Diagnostics (ASX:AT1) - Managing Director, John Kelly
Managing Director, John Kelly
Source: Atomo Diagnostics
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  • Atomo Diagnostics (AT1) is granted FDA clearance for its COVID-19 antibody test
  • The CareStart EZ Covid-19 test is a rapid antibody check which combines the company’s integrated device with a COVID-19 antibody test strip from Access Bio
  • The Emergency Use Authorisation from the FDA allows Atomo to sell its CareStart test for use in point-of-care settings in the United States
  • Both companies are now looking into commercial arrangements for the test
  • Atomo shares last traded at 13.5 cents on June 25

Atomo Diagnostics (AT1) has received FDA clearance for its COVID-19 antibody test.

The company has been granted Emergency Use Authorisation (EUA) from the US Food and Drug Administration (FDA) for point-of-care use of its CareStart EZ Covid-19 test.

CareStart is a rapid antibody test which combines its integrated device with a COVID-19 antibody test strip from Access Bio, following a supply agreement with the company.

The test is intended to detect the difference between IgM and IgG antibodies to SARS-CoV-2 in fingerstick whole blood, indicating individuals with a current or prior infection to SARS-COV-2.

In the clinical trial conducted for the FDA’s emergency use authorization, the test’s sensitivity was recorded at 97 per cent for IgG and 100 per cent for IgM, with 100 per cent specificity.  Due to these high results, CareStart is one of only a small number of rapid COVID-19 Antibody tests authorized by the FDA.

“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,” Young Ho Choi, CEO of Access Bio, said.

The EUA allows the company the sell its CareStart test for use in point-of-care settings like doctors’ offices, hospitals and emergency rooms in the United States.

“We are happy that our integrated test device has enabled Access Bio to secure EUA for point-of-care use for their COVID19 antibody test and for it to be used in a broad range of non-laboratory settings in the US,” Atomo’s Managing Director, John Kelly said.

The rapid test partnership also grants Atomo non-exclusive rights to market and distribute Access Bio’s rapid antigen test in Australia, New Zealand and India. The companies are now looking into commercial arrangements for the test.

Meanwhile, Access Bio are looking to progress an EUA for self-test kits in the United States, which can diagnose different variants of COVID-19, like the Delta variant from India, the Beta variant from South Africa, and the Alpha variant from the UK.

Atomo shares last traded at 13.5 cents on June 25.

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