TCM Life Sciences Completes Development of Novel Coronavirus Diagnostic Reagent... Moves Toward Commercialization

[Asia Economy Reporter Yoo Hyun-seok] TCM Life Sciences, a specialized company in molecular diagnostics and in vitro diagnostic devices, announced on the 30th that it has completed the development of a diagnostic reagent for the novel coronavirus and is moving forward with the commercialization of the diagnostic kit. The kit is expected to be commercialized within next month.

The diagnostic kit to be commercialized (TCM-Q Corona Ⅲ) is a kit for testing “acute respiratory infectious diseases caused by the novel coronavirus.” TCM Life Sciences leverages its experience in developing detection kits for SARS (Severe Acute Respiratory Syndrome) and MERS (Middle East Respiratory Syndrome), which belong to the same virus group Coronaviridae.

The kit diagnosis is performed by collecting specimens using a nasal swab method. RNA of the novel coronavirus is extracted from the specimen, and test results are derived through reverse transcription real-time polymerase chain reaction (RT-PCR) using a fluorescently labeled DNA probe.

The Korea Disease Control and Prevention Agency held a briefing session on the 27th for diagnostic equipment companies including TCM Life Sciences regarding the “Emergency Use Authorization System for Infectious Disease In Vitro Diagnostic Products” and confirmed their participation in the system. This system expands the scope of product approval to allow the use of unapproved products through urgent evaluation or review under the Medical Device Act when there is a national crisis risk due to infectious diseases. This system was implemented during the MERS outbreak in 2016 and the Zika virus (a virus causing fetal microcephaly) incident in 2017.

The novel coronavirus infection started in Wuhan, Hubei Province, China, and is referred to as “Wuhan pneumonia.” The virus has spread throughout China and to countries worldwide including Korea, the United States, Japan, and Singapore.

A company official stated, “Since we have the know-how of developing simultaneous confirmation test kits for novel influenza, avian influenza, and seasonal flu during the spread of the novel flu in the past, we will quickly commercialize this diagnostic kit as well,” adding, “We will do our best to ensure the safety of the public and prevent nationwide virus spread.”

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