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Regulators OKs Macrogen’s export of Covid-19 diagnostic kits

Lee Han-soo  Published 2020.05.21  17:02  Updated 2020.05.21 17:02

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Macrogen said Thursday that it has obtained approval to export AxenTM COVID-19 RT, a Covid-19 test kit, from the Ministry of Food and Drug Safety.

Macrogen's Covid-19 test kit AxenTM COVID-19 RT

The company’s test kit uses 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, which is what Macrogen said.

“Our test kit detects ORF1ab and E genes, two genes related to Covid-19, and has a high level of accuracy and target detection,” the company said. “Therefore, the test kit is regarded as a more appropriate tool to screen patients with trace amounts of Covid-19.”

Macrogen confirmed 100-percent consistency in 20 samples collected from the upper and lower airways of COVID-19 patients, the company added.

Macrogen had followed various guidelines, including a draft international standard by the International Organization for Standardization’s (ISO) technical committees of medical devices, and applied it to the test kit in April. The company also secured sufficient raw materials to produce at least 100,000 tests a week and completed the establishment of the kit production system and the process by GMP regulations.

“We are preparing to obtain emergency use authorization from the U.S. Food and Drug Administration and Europe’s CE In-Vitro Diagnostics (CE-IVD) certification,” the company said. “These authorizations are likely to increase Macrogen’s exports to the U.S. and Europe as well as Brazil and Uruguay, with which the supplies of test kits are under negotiation.”

Macrogen CEO Lee Su-kang said, “We are planning to supply our test kit to countries, which contacted us even during the test kit development phase as early as possible.”

The company will improve its test kit’s performance to detect numerous mutations of coronavirus and promptly respond to prolonged Covid-19 and other viruses, Lee added.

corea022@docdocdoc.co.kr

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