Seegene unveils new assay optimized for on-site testing in 'living with Covid-19' era

SEOUL,South Korea,Feb. 24,2022 -- Seegene Inc. (KQ 096530),South Korea's leading molecular diagnostics company,today,announced the CE-IVD marking of its Allplex™SARS-CoV-2 fast MDx Assay.

This new assay is optimized for the 'living with COVID-19' era,where mass,swift and cost-efficient testing is vital. The test can deliver results within 30 minutes,the fastest among diagnostics assays developed by Seegene,while matching the accuracy of RT-PCR tests.

Thanks to its cost efficiency,the assay is expected to allow wide-spread access and can be easily used at airports,schools and other large-scale facilities.

Faster Turnaround Times: The new test uses an isothermal amplification method thatdoes not require a thermal cycler used during the amplification process,thereby reducing the turnaround time. Seegene advanced the isothermal amplification method by utilizing its AI-based assay design system,to specifically target the genes of SARS-CoV-2. By combining such method and Seegene's applied TOCE™ technology,Allplex™SARS-CoV-2 fast MDx Assay delivers highly accurate results within 30 minutes.

Greater Testing Capacity: Fasterturnaround times lead to greater lab testing capacity of up to five times with existing Seegene's PCR instruments. Increased testing is critical as countries ease Covid-19 restrictions. Mass testing can be the most effective tool for large-scale events and venues such as concerts,airports,schools and stadiums.

High Accuracy: The assay can deliver accurate results near RT-PCR tests,even detecting COVID-19 virusesfrom asymptomatic patients.In a recent experiment,Seegene's new assay results agreed with positive results generated through conventional RT-PCR. Rapid antigen tests have been the go-to solution for timely,point-of-care testing. However,its accuracy has been questioned as,in some cases,it can givefalse-negative results,especially for transmissible but asymptomatic patients.

In the coming months,Seegene will allow laboratories to process Allplex™SARS-CoV-2 fast MDx Assay using its fully automated MDx system,AIOS. The combination of these two will offer a 'hands-free' workflow from extraction to the interpretation of results without manual intervention. This will increase the access to testing at venues where they need fast,accurate and large-scale testing. This assay's price will also be more economical than standard RT-PCR assays.

"Large-scale on-site testing is more important than ever as many countries decide to live with Covid-19," said Ho Yi,Seegene's Chief Sales and Marketing Officer. "The newly developed test canprovide accurate results and greatly reduce the turnaround time. Seegene will target global markets that require large-scale on-site testing by offering the new test at a reasonable price and will make efforts to normalize daily lives by fostering an environment where anybody can get swiftly tested."

*TOCE™ technology enables detecting and differentiating multiple targets in a single tube.