[Asia Economy Reporter Yoo Hyun-seok] On the 20th, Haim Biotech, an affiliate of NCITRON, announced that it has signed a technology transfer agreement with the National Fishery Products Quality Management Service (NFQS), under the Ministry of Oceans and Fisheries. Through this agreement, Haim Biotech will receive the patented technology for preventing false-positive PCR (Polymerase Chain Reaction) reactions developed by NFQS, which is designated as a World Organisation for Animal Health (OIE) standard laboratory.
To address misdiagnosis issues caused by false-positive results in COVID-19 testing, Haim Biotech shared its patented technology and information on preventing false-positive PCR reactions with NFQS on the 16th, leading to a mutual technology transfer agreement.
PCR is a testing method that amplifies and detects specific target DNA. It can amplify the same DNA in large quantities from a very small amount of DNA. Haim Biotech plans to develop a COVID-19 diagnostic kit that can resolve misdiagnosis issues caused by false-positive results by acquiring NFQS’s technology for preventing false-positive PCR reactions.
The patented technology from NFQS is used to determine whether false-positive reactions occur when positive control DNA contamination happens during PCR testing for shrimp white spot syndrome virus, which causes significant damage to the global shrimp aquaculture industry.
NFQS has continuously conducted research to prevent false-positive PCR reactions during precise diagnosis of aquatic animal infectious diseases that may enter the country during quarantine. It has published two papers in internationally renowned journals and holds three patented technologies. These have been applied to all precise quarantine inspections of aquatic animal infectious diseases to build a system that minimizes misdiagnosis.
Additionally, NFQS has participated in international proficiency tests organized by the European Union and has received excellent evaluations for seven consecutive years in fish disease diagnostic capability assessments designated by the OIE. It has developed and validated a new PCR method that resolves false-negative issues of viral hemorrhagic septicemia (VHS) genotypes from the US and Asia, currently adopted as an international diagnostic guideline, and has submitted proposals for revising international diagnostic guidelines to the OIE, leading the establishment of international diagnostic standards.
Haim Biotech, a molecular diagnostic technology specialist company, has obtained European Conformity (CE) certification for COVID-19 and received medical device manufacturing approval from the Ministry of Food and Drug Safety. It developed the world's first BK virus diagnostic kit using miRNA detection analysis and holds various technological capabilities in the molecular diagnostics field, including European CE certification.
Lee Jae-hoon, CEO of Haim Biotech, stated, "We want to contribute to minimizing the possibility of misdiagnosis by developing a COVID-19 diagnostic kit incorporating technology that can distinguish false-positive reactions, and we hope to widely disseminate this highly reliable diagnostic technology to other countries seeking greater trustworthiness." He added, "Through this MOU, we expect both organizations to achieve synergy effects, develop highly reliable diagnostic kits, and stabilize COVID-19 diagnostic results."
Yang Dong-yeop, Director of NFQS, emphasized, "We will provide unwavering support so that the diagnostic technology developed by NFQS enhances the reliability of COVID-19 diagnostic kits, enabling thorough quarantine based on more accurate testing."
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