Macrogen, Inc. Obtains Export Approval for COVID-19 Test Kit AxenTM Covid-19 RT
May 20, 2020 at 10:03 pm EDT
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Macrogen, Inc. announced that it has obtained export approval for COVID-19 test kit AxenTM COVID-19 RT from the Ministry of Food and Drug Safety. Earlier, Macrogen collected samples from the upper and lower airway of COVID-19 patients, and conducted a clinical trial with its test kit AxenTM COVID-19 RT. Macrogen confirmed 100% consistency in 20 samples each in the positive and negative groups and reported these results to the MFDS. Macrogen applied various guidelines including a Draft International Standard by the International Organization for Standardization's technical committees of medical devices, and completed its self-development of the test kit AxenTM COVID-19 RT. Currently, Macrogen is preparing to obtain Emergency Use Authorization from the U.S. FDA and Europe's CE In-Vitro Diagnostics. These authorizations are expected to increase Macrogen's exports across the U.S. and Europe as well as Brazil and Uruguay, in which the test kit is currently under negotiation.
Macrogen, Inc. is a Korea-based company mainly engaged in the customized transgenic and other services in the field of biomedical research. The Company operates its business through four divisions: deoxyribonucleic acid (DNA) sequencing division, DNA chips division, transgenic and knockout mouse division and oligonucleotide DNA division. Its DNA sequencing division provides genome sequencing analysis services. Its DNA chips division develops DNA chips products, such as Illumina chips, MacArray chips and customized chips. Its transgenic and knockout mouse division offers gene engineering services. Its oligonucleotide DNA division offers oligonucleotide DNA manufacturing services. The Company operates its business within domestic market and in overseas markets.