Macrogen said that it has recently won Europe’s Conformite Europeenne Mark-In Vitro Diagnostic (CE-IVD) certification for its new coronavirus test kit, Axen COVID-19 RT.

Macrogen received CE-IVD certification for Axen COVID-19 RT from the EU health regulators on Monday. (Macrogen)

Macrogen plans to enter the European market in earnest and supply diagnostic kits to government agencies and medical institutions through local corporations, branch offices, and diagnostic reagent distributors.

"The company's test kit detects two Covid-19 related genes -- E gene and ORF1ab – using a reverse transcription-polymerase chain reaction (RT-PCR) platform. It can diagnose coronavirus patients in two hours, allowing them to conduct a large number of tests quickly and efficiently," Macrogen said. "Also, as a result of clinical trials, the company has confirmed 100 percent accuracy for the kit in detecting Covid-19."

Macrogen CEO Lee Su-kang said, "With the steady increase of Covid-19 diagnoses worldwide, the company has significantly expanded its raw material acquisition and production and logistics systems to meet the demand."

Currently, the firm is discussing the supply of diagnostic kits with major countries in Europe, Latin America, Southeast Asia, and the Middle East, he added.

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