Atomo Diagnostics Limited announced that Access Bio Inc. has received Emergency Use Authorisation (EUA) from the U.S. Food and Drug Administration (FDA) for point-of-care use of its CareStartTM EZ COVID-19 IgM/IgG test. CareStart EZ COVID-19 IgM/IgG is a rapid antibody test made by combining an integrated device developed by Atomo and a rapid COVID-19 antibody test strip from Access Bio. Atomo announced on 28 July 2020 that it had entered into an agreement to supply Access Bio with its unique, integrated rapid diagnostic test (RDT) devices for use in North America with Access Bio's rapid test strip for detection of antibodies to COVID-19 subject to FDA clearance. Atomo thereafter announced, on 29 September 2020, the expansion of this rapid test partnership to grant Atomo non-exclusive rights to market and distribute Access Bio's COVID-19 rapid antigen test in Australia, New Zealand and India, subject to obtaining the required regulatory approvals in each jurisdiction. This EUA allows sales of the CareStart EZ COVID-19 IgM/IgG test for use in point-of-care settings like doctors' offices, hospitals and emergency rooms in the United States. Atomo and Access Bio are in discussions regarding their COVID-19 rapid test commercial arrangements and Atomo will keep the market informed as to any material developments.