South Korean molecular diagnostics firm Seegene has secured CE-IVD mark approval for its Allplex SARS-CoV-2 fast MDx Assay.

With the potential to deliver results within 30 minutes, the Allplex SARS-CoV-2 fast MDx Assay is suitable for use in airports, schools, and other large-scale facilities.

Seegene said that its new test leverages an isothermal amplification method, which will help avoid the use of a thermal cycler during the amplification process and minimise the turnaround time.

Using an AI-based assay design system, Seegene advanced the isothermal amplification method to specifically target the genes of SARS-CoV-2. Allplex SARS-CoV-2 fast MDx Assay also uses applied TOCE technology.

Allplex SARS-CoV-2 fast MDx Assay, which also uses applied TOCE technology, is said to facilitate faster turnaround times to increase lab testing capacity of up to five times with existing Seegene’s PCR instruments.

Seegene chief sales and marketing officer Ho Yi said: “The newly developed test can provide 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.”

Designed to deliver accurate results near RT-PCR tests, the Allplex test also can identify Covid-19 viruses from asymptomatic patients.

Seegene stated that it will enable laboratories to process Allplex SARS-CoV-2 fast MDx Assay using its AIOS fully automated MDx system in the coming months.

Earlier this month, Seegene announced that it had developed Allplex SARS-CoV-2 Variants Ⅰ Assay, which is claimed to be the world’s first Covid-19 diagnostic variant test.