NEW YORK – Kogene Biotech said last week that it has received regulatory approval in Korea for its novel coronavirus test. The test, called the 2019 Novel Coronavirus Real-time PCR Kit, has been granted Emergency Use Assessment and Listing (EUAL) in Korea.
Specifically, the Seoul, Korea-based company has been granted EUAL from the Korea Centers for Disease Control and the Korea Food and Drug Administration. It is also the first novel coronavirus test to be granted EUAL in Korea, according to the firm.
Kogene has now ramped up production of the test to provide it to the Korea CDC as well as 50 Korean hospitals that have designated nCoV testing labs. The company is also beginning to evaluate the test in China, Japan, KSA, UAE, Iraq, Vietnam, and Bahrain.