Access BioCareSuppub COVID19 Self-Diagnosis Kit Gets FDA Approval for Sale
Feb 04, 2025
Access Bio (CEO Choi Young-ho) announced on the 4th that it has obtained official sales approval (FDA 510(k) from the U.S. Food and Drug Administration (FDA) for the CareSuperb COVID-19 Antigen Home Test (CareSuperb COVID-19) with its high-sensitivity rapid diagnosis technology.
Access Bio's CareShopped Corona Self-Diagnosis Kit is a product that implements sensitivity beyond the limits of existing rapid diagnostic kits by dramatically increasing the antigen-antibody reaction time by installing a special adapter in a rapid diagnostic device. At the same time, it is designed to provide rapid diagnosis results within 15 minutes, boasting technology with both high sensitivity and convenience.
The product has demonstrated outstanding performance close to molecular diagnostics, recording a sensitivity of 97.2% and a specificity of 98.8% in clinical trials for FDA marketing authorization. This is the highest level of sensitivity among FDA-approved products, and compared to the 82-91% sensitivity of current products on the market, AccessBio products show an overwhelming sensitivity of more than 97%, with differentiated competitiveness.
During the COVID-19 pandemic, rapid diagnosis kits were in the spotlight for their advantages such as low diagnostic cost, quick results, and ease of use, but lower sensitivity than molecular diagnosis has been pointed out as a disadvantage. However, AccessBio has successfully overcome these limitations through CareShoop technology, and it has already completed a U.S. patent to protect the technology.
The worry-sensitive CareShoop technology developed by Access Bio is significant in that it has established itself as a key base technology that can expand beyond COVID-19 to diagnosing various infectious diseases. Based on this, Access Bio plans to continue to expand its lineup of quick diagnostics for anxiety.
A company representative said "As we are diversifying our portfolio to diagnostic products for various infectious diseases such as malaria, flu, and venereal diseases, including combo kits that can diagnose both COVID-19 and flu at the same time, we look forward to further performance of CareShopped technology in the diagnostic market in the future."
Access Bio's CareShopped Corona Self-Diagnosis Kit is a product that implements sensitivity beyond the limits of existing rapid diagnostic kits by dramatically increasing the antigen-antibody reaction time by installing a special adapter in a rapid diagnostic device. At the same time, it is designed to provide rapid diagnosis results within 15 minutes, boasting technology with both high sensitivity and convenience.
The product has demonstrated outstanding performance close to molecular diagnostics, recording a sensitivity of 97.2% and a specificity of 98.8% in clinical trials for FDA marketing authorization. This is the highest level of sensitivity among FDA-approved products, and compared to the 82-91% sensitivity of current products on the market, AccessBio products show an overwhelming sensitivity of more than 97%, with differentiated competitiveness.
During the COVID-19 pandemic, rapid diagnosis kits were in the spotlight for their advantages such as low diagnostic cost, quick results, and ease of use, but lower sensitivity than molecular diagnosis has been pointed out as a disadvantage. However, AccessBio has successfully overcome these limitations through CareShoop technology, and it has already completed a U.S. patent to protect the technology.
The worry-sensitive CareShoop technology developed by Access Bio is significant in that it has established itself as a key base technology that can expand beyond COVID-19 to diagnosing various infectious diseases. Based on this, Access Bio plans to continue to expand its lineup of quick diagnostics for anxiety.
A company representative said "As we are diversifying our portfolio to diagnostic products for various infectious diseases such as malaria, flu, and venereal diseases, including combo kits that can diagnose both COVID-19 and flu at the same time, we look forward to further performance of CareShopped technology in the diagnostic market in the future."
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This article was translated by Naver AI translator.
