Seegene Inc. 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 that does 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: Faster turnaround 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 viruses from 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 give false-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.