TCM Saenggwa Supplies COVID-19 Diagnostic Kits to US CLIA-Certified Laboratory

[Asia Economy Reporter Hyungsoo Park] Molecular diagnostic developer TCM Life Sciences announced on the 3rd that it has signed a contract to supply its self-developed "Novel Coronavirus Infection (COVID-19) Diagnostic Kit" to the US company Lab USA.

Lab USA, located in Massachusetts, USA, is a laboratory that diagnoses and treats diseases using diagnostic reagents and medical devices. It has completed CLIA (Clinical Laboratory Improvement Amendments) certification, the US federal government's medical analysis standard. Under this contract, Lab USA will receive 100 kit samples from TCM Life Sciences for internal evaluation and plans to request additional product supplies.

TCM Life Sciences' diagnostic kit is based on RT-PCR (reverse transcription polymerase chain reaction) technology, which diagnoses COVID-19 infection within 1 hour and 30 minutes after ribonucleic acid (RNA) extraction, following the World Health Organization (WHO) recommended guidelines. On the 16th of last month, TCM Life Sciences obtained the European in vitro diagnostic device (CE-IVD) certification for this kit.

In the US, laboratories with CLIA certification can autonomously use COVID-19 diagnostic kits without FDA approval. While supplying to laboratories, the company plans to submit documentation for FDA approval next week. The domestic supply strategy involves emergency use authorization from the Korea Disease Control and Prevention Agency, and exports will proceed after export approval from the Ministry of Food and Drug Safety, following a two-track strategy.

A company official stated, "Since we have started entering the worsening US market, we will actively respond and contribute to calming the global spread of COVID-19," adding, "Inquiries for overseas orders have surged besides the US."

He continued, "As soon as we receive emergency use authorization from the Korea Disease Control and Prevention Agency or government export-import approval, we will be able to supply products to various countries," emphasizing, "We will strive to enable additional supplies as soon as possible."

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