TCM Life Sciences Obtains Export Approval for COVID-19 Diagnostic Kits "Accelerating Overseas Supply"

[Asia Economy Reporter Jang Hyowon] Molecular diagnostics specialist TCM biosciences announced on the 9th that it has received export approval from the Ministry of Food and Drug Safety for its self-developed "Novel Coronavirus Infection (COVID-19) Diagnostic Kit."

TCM biosciences' diagnostic kit, "TCM-Q CoronaⅢ," is a product based on gene amplification (RT-PCR) technology following the World Health Organization (WHO) recommended guidelines. It can diagnose COVID-19 infection within 1 hour and 30 minutes after ribonucleic acid (RNA) extraction.

After conducting clinical trials with a major domestic clinical contract organization, TCM biosciences explained that its diagnostic kit demonstrated excellent performance with both sensitivity (the probability of detecting positive samples as positive) and specificity (the probability of detecting negative samples as negative) at 99.9%.

Based on the product's competitiveness, the company plans to accelerate overseas supply of the COVID-19 diagnostic kit through this approved authorization. It has also established an export foundation by acquiring European in vitro diagnostic device (CE-IVD) certification and completing kit supply and evaluation contracts with LabUSA in the United States.

A company official stated, "With a flood of order inquiries from overseas, obtaining this approval has made product export possible," adding, "We will proceed with supply contracts sequentially and strive to supply worldwide without any setbacks."

He further emphasized, "We will also create synergy by linking with COVID-19 related businesses of affiliated companies."

TCM biosciences is a subsidiary of the BioLeaders Group, with NextBT as its largest shareholder.

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