Genomictree Obtains Export Approval and European Certification for COVID-19 Diagnostic Kit

[Asia Economy Reporter Choi Dae-yeol] Genomictree, a company specializing in in vitro diagnostic devices, announced on the 16th that its COVID-19 diagnostic kit 'AccuraDtect' has received domestic export certification and European certification (CE-IVD).

The newly certified AccuraDtect (RT-qPCR SARS-CoV2) uses a molecular diagnostic method targeting the most abundant leader sequence and the N2 gene region within COVID-19 infected cells. It diagnoses viral infection by amplifying the target using real-time polymerase chain reaction (PCR).

The company is currently undergoing review after applying for Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for this diagnostic kit. It is also being supplied as a diagnostic reagent necessary for developing proprietary diagnostic methods used in a clinical diagnostic lab (CLIA lab) located in Los Angeles, USA. The United States currently has the highest number of COVID-19 patients worldwide, and considering the urgent situation, diagnostic kit companies can use their kits conditionally before receiving domestic emergency use approval once verification procedures are completed and notified.

A company representative stated, "To obtain export approval from the Ministry of Food and Drug Safety, we conducted clinical tests on specimens from COVID-19 patients and normal specimens, confirming high clinical sensitivity of the target," adding, "We have also completed expansion that meets domestic and international manufacturing and quality management system standards to meet overseas export demand."

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