Genomictree, Export of COVID-19 Molecular Diagnostic Products to the United States

[Asia Economy Reporter Hyunseok Yoo] Genomictree, a biomarker-based in vitro early cancer diagnosis specialist company, announced on the 30th that it will export its molecular diagnostic products for the novel coronavirus infection (COVID-19) to the Los Angeles area in the United States.

Currently, the United States allows entry into the market for COVID-19 molecular diagnostic products either through the FDA's Emergency Use Authorization (EUA) or through verification procedures conducted by diagnostic testing companies managed by state governments (CLIA Laboratory).

Genomictree has completed the development of an upgraded product for the U.S. FDA Emergency Use Authorization (EUA). This upgraded product enhances sensitivity by simultaneously measuring the N gene recommended by the U.S. CDC, the leader sequence most commonly present along with the N gene, and the internal control gene RNase P in a single tube.

A Genomictree official stated, “The upgraded product meets all the requirements for U.S. EUA and diagnostic testing companies’ LDT (laboratory developed test) by including not only internal and external controls but also controls that evaluate whether the entire testing process was conducted properly. Our U.S. subsidiary, ‘Promise Diagnostics,’ directly contacted local diagnostic testing companies in the U.S. and achieved satisfactory performance through consulting and technical guidance for LDT verification locally, enabling export to the Los Angeles area.”

Meanwhile, Genomictree is separately preparing for the U.S. FDA Emergency Use Authorization with the help of FDA consultants and plans to apply as soon as possible.