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GCMS wins regulatory nod to export rapid Covid-19 test kit
  • By Shim Hyun-tai
  • Published 2020.08.04 17:33
  • Updated 2020.08.04 17:33
  • comments 0

GC Medical Science (GCMS) on Monday won permit from the Ministry of Food and Drug Safety Monday to export its point-of-care molecular diagnostic kit "GENEDIA W COVID-19 Colorimetric LAMP premix kit."

GCMS had obtained export approval for two anti-body and one molecular test kits. The newly approved test kit can check Covid-19 using Loop-Mediated Isothermal Amplification (LAMP), which amplifies genes at a constant temperature without needing to repeat heating and cooling.

GC Medical Science (GCMS)’s GENEDIA W COVID-19 Colorimetric LAMP premix kit obtained export approval from the Ministry of Food and Drug Safety on Monday. (GCMS).

The test kit can shorten the time to less than an hour required to collect samples and analyze the result.

Also, the new assay of GCMS is characterized by not requiring large equipment than the existing molecular diagnostic kit as the presence of a virus can be confirmed immediately through the color change of reagent with the applied colorimetric technology.

The company explained that strengthening the product line of Covid-19 test kits would allow efficient responses to meet each country's different demands.

"We expect this test kit will be distributed mainly to developing countries where they have a hard time installing large and expensive diagnostic equipment," GCMS CEO Ahn Eun-eok said. "GCMS plans to build an integrated diagnostic platform for new infectious diseases by adding our own researched and developed items."

shim531@docdocdoc.co.kr

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