[Asia Economy Reporter Park Jihwan] Access Bio is soaring over 15% following the news that it received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its COVID-19 antibody rapid diagnostic kit.
As of 2:47 PM on the 25th, Access Bio is trading at 31,050 KRW, up 15.08% from the previous trading day.
On this day, Access Bio announced that it had obtained the FDA's EUA for its All-In-One COVID antibody rapid diagnostic kit. The approved product, 'CareStart™ EZ COVID-19 IgM/IgG,' combines the All-In-One device developed by Australia's Atomo Diagnostics with Access Bio's COVID antibody diagnostic strip. It can determine the presence of antibodies in the body and diagnose COVID infection within 15 to 20 minutes using a simple finger prick blood sample.
A company representative stated, "With predictions of a COVID resurgence this fall and the possibility of a third vaccine dose, antibody testing is expected to assist in determining the timing for the third vaccination."
Currently, Access Bio is also in the process of obtaining EUA from the U.S. FDA for its COVID-19 antigen self-test kit. Clinical trials have been completed, and the product is under FDA review.
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