Genomictree "Upgraded COVID-19 Molecular Diagnostic Product... Export Approval and European CE-IVD Certification"

[Asia Economy Reporter Yoo Hyun-seok] Genomictree, a biomarker-based in vitro cancer early diagnosis specialist company, announced on the 16th that its molecular diagnostic kit for COVID-19, AccuraDtect RT-qPCR SARS-CoV2, obtained both export approval from the Korea Ministry of Food and Drug Safety (hereinafter ‘MFDS’) and European CE-IVD certification on the 15th.

The diagnostic product that received MFDS export approval and European CE-IVD certification targets the leader sequence (Leader sequence 72nts), which is most abundant in COVID-19 infected cells, and the N2 gene region, amplifying them via real-time polymerase chain reaction (RT-qPCR) to diagnose viral infection.

This product has completed submission for Emergency Use Authorization (EUA) approval to the U.S. FDA to be sold and supplied in the U.S. market under the Genomictree brand name as a ‘diagnostic kit’ and is currently under review. During the review period, the diagnostic kit can be provisionally supplied to the U.S. market. It is also currently supplied as diagnostic reagents necessary for developing laboratory developed tests (LDT) at a clinical diagnostic lab (CLIA LAB) located in the Los Angeles area.

Considering the urgency of the COVID-19 situation, the U.S. conditionally allows the supply and use of diagnostic kits during the review period before FDA EUA approval if the diagnostic kit manufacturer completes and notifies the validation process.

A Genomictree official stated, “To obtain MFDS export approval, clinical tests were conducted using specimens from actual COVID-19 positive patients and normal specimens, confirming that the clinical sensitivity targeting the leader sequence is relatively superior.” He added, “Although the number of new COVID-19 cases is decreasing domestically, overseas companies where patients continue to occur show high interest in the distinctiveness of our product targeting the leader sequence.”

He emphasized, “With the acquisition of MFDS export approval and European CE-IVD certification, we can now actively proceed with exports responding to supply inquiries not only from the U.S. market but also from most regional markets including Europe. We have also completed the expansion of production facilities for diagnostic products that comply with domestic and international medical device manufacturing management and quality control system standards to meet demand.”

Meanwhile, Genomictree is a cancer early diagnosis specialist company that has developed and patented proprietary cancer biomarker discovery and detection technologies. To respond to the globally prevalent COVID-19, the company has developed molecular diagnostic products with high accuracy and sensitivity using its technology and is exporting them overseas.

This content was produced with the assistance of AI translation services.