Atomo Diagnostics Limited Receives FDA Clearance for Covid-19 Antibody Test
June 27, 2021 at 06:19 pm EDT
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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.
Access Bio, Inc. is engaged in research, development and manufacturing of in vitro rapid diagnostic tests, biosensors and molecular diagnostic products. Its product list includes covid-19 detection kits, rapid diagnostic tests, analyzers and molecular diagnostics. Its covid-19 detection kits include CareStart COVID-19 Antigen Home Test, CareStart COVID-19 Antigen, CareStart COVID-19 MDx RT-PCR, CareStart COVID-19 lgM/lgG and CareStart EZ COVID-19 lgM/lgG. Its rapid diagnostic tests include CareStart EZ HIV, CareStart Flu A&B Plus+, CareStart G6PD RDT, CareStart Malaria RDT, CareStart Dengue RDT, care US HIV 1/2 and care US Syphilis. The analyzers include care SURE Analyzer 100, care SURE A1c Cartridge, care SURE ACR Cartridge, care SURE CRP Cartridge, care START S1 Analyzer and care START G6PD Biosensor. The molecular diagnostics include care GENE HPV Screening kit-H, care GENE Zika Virus RT-PCR kit, care GENE STD detection kit, care GENE Dengue Virus genotyping kit and others.