Macrogen gets MFDS approval to export Axen Covid-19 RT test kit

The new Covid-19 test kit from Macrogen uses RT-PCR technology, and is capable of confirming infection in a person with two hours

Macrogen has secured the South Korea’s Ministry of Food and Drug Safety (MFDS) approval to export its Covid-19 test kit, dubbed Axen Covid-19 RT.

The biotech company said that its Covid-19 test kit leverages RT-PCR, and is capable of confirming infection in a person with two hours, allowing large number of tests conducted in a less time.

The kit has been designed to detect two genes ORF1ab and E, which are associated with Covid-19, and has a high level of accuracy and target detection. The test is said to be the more appropriate option to screen patients with trace amounts of Covid-19.

Macrogen CEO Sukang Lee said: “We are planning to supply our test kit to major countries, which contacted us even during the test kit development phase and were looking forward to export approval together with us, first and as early as possible.

“We will not only improve our test kit’s performance to detect numerous mutations of coronavirus, which continue to appear in the future, but also promptly respond to prolonged Covid-19 and any new emerging virus.”

Axen Covid-19 RT has been approved based on results from the Macrogen’s clinical trial

Macrogen has previously conducted a clinical trial with its Axen Covid-19 RT, on samples collected from the nose, mouth, neck, and bronchus of Covid-19 patients.

The South Korean regulatory agency has approved the Axen Covid-19 RT, based on results from the clinical trial, which showed 100% consistency in 20 samples each in the positive and negative groups.

The company has applied various guidelines including a Draft International Standard by the International Organization for Standardization’s (ISO) technical committees of medical devices to complete its self-development of the Axen COVID-19 RT test kit.

Macrogen is currently in preparations to secure Emergency Use Authorization (EUA) from the US FDA and CE In-Vitro Diagnostics (CE-IVD) approval in Europe.

Once received, the authorisations are expected to increase exports of test kits across the US and Europe along with Brazil and Uruguay. – NSMedical

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