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Seegene Obtains CE Mark for Isothermal Amplification-Based SARS-CoV-2 Assay

NEW YORK — Seegene on Thursday announced it has obtained the CE-IVD mark for its Allplex SARS-CoV-2 fast MDx Assay, an isothermal amplification test that provides results in 30 minutes.

The Seoul, South Korea-based firm said the assay is expected to allow broad access to testing at airports, schools, and other large-scale facilities.

"Seegene will target global markets that require large-scale, on-site testing by offering the new test at a reasonable price," Ho Yi, Seegene's chief sales and marketing officer, said in a statement.

In the coming months, laboratories will process the Allplex SARS-CoV-2 fast MDx Assay using Seegene's All-In-One System, or AIOS, enabling a hands-free workflow from extraction to the interpretation of results, the firm added.

Seegene said it used artificial intelligence to develop the isothermal amplification method for its new assay. Combined with tagging oligonucleotide capture and extension technology, the method enables "highly accurate results," the firm said, adding that the assay can provide results with accuracy levels near those of RT-PCR tests and detect SARS-CoV-2 in asymptomatic patients.