TCM Saengmyeong Science Obtains European CE Certification for COVID-19 Diagnostic Kit... "Actively Promoting Exports"
[Asia Economy Reporter Hyunseok Yoo] Molecular diagnostics specialist TCM Life Sciences announced on the 16th that its "Novel Coronavirus Infection (COVID-19) Diagnostic Kit" has obtained the European In Vitro Diagnostic Device (CE-IVD) certification.
With this certification, exports are expected to be possible to numerous countries including those in the European Union (EU) as well as Southeast Asia and the Middle East where CE-IVD certification is applicable.
The diagnostic kit "TCM-Q CoronaⅢ," developed by TCM Life Sciences in February, is based on RT-PCR gene amplification technology that rapidly diagnoses COVID-19 infection within 1 hour and 30 minutes after RNA (ribonucleic acid) extraction, following the World Health Organization (WHO) recommended guidelines. Leveraging its experience and patented technology from developing kits during the 2009 H1N1 flu outbreak, the company has drastically reduced the time required for COVID-19 diagnosis while enhancing sensitivity and accuracy.
A company official stated, "Since February, there have been continuous inquiries from overseas stakeholders, mainly in the Middle East and Europe, regarding the COVID-19 diagnostic kit, and we have now obtained CE-IVD certification. Overseas demand is surging due to the global spread of COVID-19 and last week's pandemic declaration by the World Health Organization." He added, "We are rapidly negotiating exports with countries such as Iran, India, Malaysia, and Egypt, and we will actively enter global markets including Europe and the United States."
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TCM Life Sciences' affiliated hospital, TCM Lab Testing Center (TCM Lab Clinic), was designated as a COVID-19 testing institution by the Korea Disease Control and Prevention Agency on the 3rd and is currently conducting COVID-19 confirmation tests for patients. TCM Life Sciences is the largest shareholder of BioLeaders, a company listed on the KOSDAQ.
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