Ncitron "Haim Biotech Develops COVID-19 Diagnostic Kit Applying Bidirectional Gene Amplification Technology"
[Asia Economy Reporter Hyunseok Yoo] NCtron announced on the 30th that its affiliate Haim Biotech has succeeded in developing a molecular diagnostic kit using specific bidirectional strand displacement gene amplification technology (SBDE-PCR).
Haim Biotech achieved this result after receiving emergency guidelines from the Korea Disease Control and Prevention Agency and the Ministry of Food and Drug Safety to begin developing a diagnostic kit for the novel coronavirus infection (COVID-19). Haim Biotech is a company possessing technology to detect and analyze microRNA, a next-generation molecular diagnostic biomarker. Globally, only three companies, including Haim Biotech and two US-based global firms, have this related technology. Haim Biotech has already completed domestic patent registration for its core technology and is currently filing international patents in the US, Europe, Japan, and China.
Haim Biotech plans to apply for emergency use authorization for the COVID-19 diagnostic kit and is proceeding with approval procedures with the Korea Disease Control and Prevention Agency and the Ministry of Food and Drug Safety, while also promoting related approvals for overseas exports. NCtron plans to distribute Haim Biotech’s diagnostic kits as soon as the relevant approvals are obtained.
This molecular diagnostic kit can confirm COVID-19 even with a small amount of virus, making it applicable to asymptomatic or mildly symptomatic patients. A Haim Biotech representative explained, "Many molecular diagnostic kits released so far have often misdiagnosed positive cases as negative when there was not enough virus present. However, the molecular diagnostic kit developed by Haim Biotech this time uses specific bidirectional strand displacement gene amplification technology (SBDE-PCR) and can confirm COVID-19 even with a small amount of virus. Since the amount of virus in specimens from asymptomatic or mildly symptomatic patients is quite low, this is the only molecular diagnostic kit capable of identifying confirmed cases among them."
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Meanwhile, besides the COVID-19 diagnostic kit, Haim Biotech is engaged in businesses applying microRNA technology for opportunistic infection diagnosis, anticancer drug efficacy prediction diagnosis, and early cancer diagnosis. In February last year, it succeeded in developing a BK virus diagnostic kit. Additionally, since November last year, it has been conducting research and development in a consortium format in Korea and the US with the goal of developing various virus diagnostic kits.
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