PR83799

SEOUL, South Korea, Apr. 29, 2020 /PRNewswire=KYODO JBN/--

SEASUN BIOMATERIALS announced on 1 May that they are about to release their

second COVID-19 assay "AQ-TOP COVID-19 Rapid Detection Kit" just after the

completion of FDA EUA (April-27) of their U-TOP COVID-19 Real-Time Detection

Kit.

Analytical Speed, Sensitivity and Specificity of the conventional molecular

methods were enhanced with AQ-TOP technology through the combination of

isothermal amplification and PNA (Peptide Nucleic Acid) detection probe, which

has high accurate binding efficiency to the target nucleic acid.

This kit targets ORF1ab gene of 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.

CEO Hee-Kyung Park said, "Customers don't need to purchase an 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. 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."

SEASUN BIOMATERIALS is currently distributing its real-time PCR based "U-TOP

COVID-19 Detection Kit" which acquired CE-IVD marking, Certificate of Free

Sales of MFDS (in February) and the FDA-EUA (on April-27), to overseas

including Europe and the Middle Eastern countries.

About SEASUN BIOMATERIALS

SEASUN BIOMATERIALS is an in vitro diagnostic company that develops molecular

diagnostic platforms of infection diseases, cancer as well as genetic and

epigenetic disorders.

We develop and commercialize innovative real-time PCR-based diagnostic

platforms through the development of our proprietary technologies to provide

more advanced molecular diagnostic services.

www.seasunbio.com

Source: SEASUN BIOMATERIALS

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Caption: SEASUN BIOMATERIALS, AQ-TOP COVID-19 rapid detection Kit