K-Bio Stands Tall on Global Stage... International Standard Established for Infectious Disease Gene Amplification Testing Method

Only Member State Approval Left for Enactment... "Set to Become a Global Standard"

[Image source=Yonhap News]

[Asia Economy Reporter Moon Chaeseok] The gene amplification method for infectious disease in vitro diagnostic testing proposed by Korea is becoming the global standard.

On the 29th, the Ministry of Trade, Industry and Energy's National Institute of Technology and Standards and the Ministry of Food and Drug Safety announced that Korea's "Gene Amplification Testing Method for Detection of Microbial Pathogens" has been approved as an International Standard Draft (DIS).

The international standard has passed up to the 4th stage out of 6. Generally, the process goes through 'New Proposal (NP) → Working Draft (WD) → Committee Draft (CD) → Draft International Standard (DIS) → Final Draft International Standard (FDIS) → International Standard (IS) establishment.'

According to the National Institute of Technology and Standards and the Ministry of Food and Drug Safety, only the approval of all member countries remains for this standard draft. It is expected to be established as an international standard within this year. Legally, it is like passing the review of the National Assembly's Legislation and Judiciary Committee and only awaiting submission to the plenary session.

The method approved as the international standard draft defines the entire procedure and method for nucleic acid amplification-based in vitro diagnostic testing that can be used for diagnosing various infectious diseases.

It is a standard applicable to various nucleic acid amplification testing methods, including the real-time gene amplification method applied to kits used domestically for diagnosing the novel coronavirus infection (COVID-19).

The government proposed the draft to the International Organization for Standardization in 2016. Since then, it has closely cooperated with technical committees of the ISO from the United States, Europe, Japan, and other countries. Finally, in February of this year, the draft international standard (DIS) passed the vote with unanimous approval from member countries.

The government stated that this case of international standardization is significant because diagnostic kits developed with domestic technology have successfully entered the market and are now establishing themselves as the global standard.

Officials from the National Institute of Technology and Standards and the Ministry of Food and Drug Safety said, "The approval of this international standard draft is the result of collaborative efforts by government agencies to proactively develop infectious disease diagnostic methods and lead international standardization," adding, "Amid growing global interest in Korea's COVID-19 diagnostic capabilities, this will enhance international trust in Korea's infectious disease diagnostic devices and help domestic companies expand into overseas markets."