Genomictree said Thursday that its Covid-19 test kit has won both the export approval from the Ministry of Food and Drug Safety and Conformite Europeen marking for in-vitro diagnostics (CE-IVD).
The company’s molecular diagnostics kit, named AccuraDtect RT-qPCR SARS-CoV2, targets the leader sequence 72nts N2 gene sites, which are most present in the infected cells. The test kit amplifies the virus in the patients’ sample by using real-time polymerase chain reaction (RT-PCR).
Genomictree has also submitted emergency use approval (EUA) to the U.S. Food and Drug Administration for its sales and distribution.
While waiting for the FDA’s approval, the company can temporarily supply its diagnostic kits to the U.S. market. State-managed Clinical Laboratory Improvement Amendments Laboratories in Los Angeles are importing Genomictree’s test kits to develop their laboratory-developed test for Covid-19.
Given the urgent situation, the U.S. government is allowing foreign test kit developers to export their products temporarily while they wait for the FDA’s emergency use approval if they submitted validation reports to it.
According to a Genomictree official, the company conducted clinical trials with samples of coronavirus patients and healthy people to gain export permission. The Korean company found that the clinical sensitivity of the leader sequence target was exceptionally higher.
“Although the number of new Covid-19 patients is decreasing in Korea, those of some foreign countries are continually increasing. Foreign companies were very interested in our test kit’s method to target leader sequence distinctly,” the Genomictree official said.
With the export permission from the Korean regulator and the CE-IVD certification, the company has become capable of making shipments in earnest responding to supply requests from abroad, including the U.S. and Europe, the official added.
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