SEASUN BIOMATERIALS Launches COVID-19 Rapid Molecular Assay

This kit targets the ORF1ab gene of the SARS-CoV-2 with an endogenous control human RNase P gene. The kit obtained CE-IVD marking in March, and now examinations of an export approval of MFDS (Korea's Ministry of Food & Drug Safety) and the FDA EUA are underway.

“Customers don't need to purchase additional equipment. The existing real-time PCR instrument which is frequently used for COVID-19 diagnosis can be used as it is. The average number of specimens that can be tested per unit (12 hours per day) is 3,400, which is 5-6 times faster than before,” said CEO Hee-Kyung Park. “Currently, as COVID-19 is rapidly spreading globally and re-infection is reported frequently, we will produce more than 200,000 tests per day to deliver as fast as possible. As soon as the permit for the AQ-TOP COVID-19 Rapid Detection Kit has been completed, the kit will be provided globally and with the advantage that the rapid COVID-19 diagnosis will contribute to quick follow-up.”

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