HeimBiotek Recognized as “Top Tech Company” at 2024 China Overseas Talent Innovation and Entrepreneurship Competition
HeimBiotek Recognized as Top Tech Company in Life and Health at 2024 China Overseas Talent Innovation and Entrepreneurship Competition HeimBiotek has been selected as the “Top Tech Company” in Life and Health at the “2024 China Overseas Talent Innovation and Entrepreneurship Competition,” held in Nanning, China, from the 11th~13th of July. This competition provides a platform for participants to showcase their technology and innovation, with outstanding projects receiving substantial support. The event was hosted by the China Association for Science and Technology and the People’s Government of Guangxi Zhuang Autonomous Region, and co-organized by several organizations, including the China International Science and Technology Exchange Center, Guangxi Association for Science and Technology, Nanning People’s Government, Nanning Association for Science and Technology, National Offshore Innovation and Entrepreneurship for Overseas Professionals (Nanning), and Shanghai Oracle Bay Group. The competition featured five categories: Life and Health, Information Technology, Green and Low-Carbon, Advanced Manufacturing, and Future Industry and Cultural Creativity, with a total of 2032 project submissions from 50 countries. 136 outstanding projects from 24 countries advanced to the finals with 10 teams from each track being selected for the Innovation and Entrepreneurship List. HeimBiotek was recognized as the “Top Tech Company” for its HB miRDx™ EarlyHCC Kit, which utilizes circulating miRNA biomarkers for early-stage liver cancer (stages 1-2) diagnosis. The HB miRDx™ EarlyHCC Kit has concluded exploratory clinical trials, having demonstrated significant results in two clinical experiments with a total of 500 samples. Preparation are currently underway for confirmatory clinical trials with the Ministry of Food and Drug Safety of the Republic of South Korea.
HeimBiotek Transfers Technology to Prevent False Positive PCR Results
HeimBiotek Transfers Technology to Prevent False Positive PCR Results HeimBiotek announced on the 16th that it has signed a technology transfer agreement with the National Fisheries Products Quality Management Service (NFQS) under the Ministry of Oceans and Fisheries. Through this agreement, HeimBiotek will receive the patented technology from NFQS, an OIE standard laboratory, to prevent false positive reactions in PCR (Polymerase Chain Reaction) tests. PCR is a method that amplifies and detects specific target DNA, enabling the mass amplification of identical DNA from very small amounts. The patented technology transferred from NFQS is designed to determine false positive reactions that can occur during the diagnosis of White Spot Syndrome Virus (WSSV) in shrimp, which causes significant damage to the global shrimp farming industry, due to contamination of the positive control DNA. HeimBiotek plans to utilize this technology to develop a COVID-19 diagnostic kit that can solve the issue of misdiagnosis caused by false positives. HeimBiotek’s CEO stated, “We aim to minimize the possibility of misdiagnosis with a COVID-19 diagnostic kit incorporating technology to identify false positive reactions and hope to widely disseminate this highly reliable diagnostic technology to other countries.” The NFQS director promised, “We will provide unwavering support to ensure that the developed diagnostic technology enhances the reliability of COVID-19 test kits, enabling more thorough quarantine measures based on accurate testing.” This content is partially excerpted from a news article. Source: https://www.docdocdoc.co.kr/news/articleView.html?idxno=2001028
HeimBiotek’s COVID-19 Diagnostic Kit Receives CE Certification in Europe
HeimBiotek’s COVID-19 Diagnostic Kit Receives CE Certification in Europe HeimBiotek has received CE certification for its COVID-19 diagnostic kit, paving the way for exports to Europe. On the 23rd, HeimBiotek announced that it obtained the CE certification following the manufacturing approval for in vitro diagnostic medical devices for COVID-19. HeimBiotek is currently in contact with several buyers for export to the European region. A company representative stated, “Inquiries for European distribution of our COVID-19 diagnostic kit are ongoing, and we plan to finalize distribution agreements soon to commence exports.” HeimBiotek is also seeking FDA approval for its COVID-19 diagnostic kit in the United States. The representative added, “We expect to receive FDA approval soon and are discussing export plans for the North American market.” The certified COVID-19 diagnostic kit uses the RT-PCR method, allowing for the confirmation of COVID-19 infection within two hours, enabling rapid large-scale testing. The representative further noted, “Inquiries about the diagnostic kit have surged, and with the approval from the Ministry of Food and Drug Safety and this certification, we expect to boost our export efforts significantly.” This content is partially excerpted from a news article. Source: https://www.mdtoday.co.kr/mdtoday/index.html?no=390809
MFDS Approves HB BestPlex™ COVID-19 In vitro Diagnostic Medical Device
MFDS Approves HB BestPlex™ COVID-19 In vitro Diagnostic Medical Device HeimBiotek Receives Manufacturing Approval for COVID-19 Diagnostic Device On June 12, HeimBiotek announced that it has been granted manufacturing approval by the Ministry of Food and Drug Safety (MFDS) for a COVID-19 in vitro diagnostic device. The newly approved product is a diagnostic kit that can quickly detect COVID-19 infection in vitro. A company representative stated, “As COVID-19 continues to spread and persist both domestically and internationally, we are expanding our related business to offer products that are easy for consumers to use and exhibit excellent efficacy.” This content is partially excerpted from a news article. Source: https://www.mdtoday.co.kr/mdtoday/index.html?no=389792
HeimBiotek Develops COVID-19 Diagnostic Kit Using SBDE™ PCR Technology
HeimBiotek Develops COVID-19 Diagnostic Kit Using SBDE™ PCR Technology HeimBiotek announced that it has successfully developed a diagnostic kit using specific bi-directional extension PCR technology (SBDE™-PCR). HeimBiotek possesses technology for detecting and analyzing microRNA, a next-generation molecular diagnostic biomarker. The company has completed domestic patent registration for its core technology and is currently in the process of international patent applications in the United States, Europe, Japan, and China. The company plans to apply for emergency use authorization for its COVID-19 diagnostic kit. HeimBiotek is proceeding with approval procedures from the Korea Disease Control and Prevention Agency (KDCA) and the Ministry of Food and Drug Safety (MFDS), while also pursuing related approvals for international export. This content is partially excerpted from a news article. Source: https://www.mdtoday.co.kr/mdtoday/index.html?no=382241
HeimBiotek Forms Consortium for Virus Diagnostic Kit Development
HeimBiotek Forms Consortium for Virus Diagnostic Kit Development HeimBiotek announced its success in developing a BK virus diagnostic kit in February and is now forming consortia in South Korea and the United States to accelerate the development of various virus diagnostic kits. The company will leverage its proprietary Specific Bidirectional Elongation Polymerase Chain Reaction (SBDE™ PCR) technology to develop miRNA analysis diagnostic kits. Consortia in both countries will spearhead this research and development. HeimBiotek entered the miRNA detection and analysis market as the third company globally and the first in South Korea. Their Reverse Transcription Quantitative PCR (RT-qPCR) technology offers higher reactivity and accuracy compared to existing miRNA detection methods. In South Korea, HeimBiotek is collaborating with Yonsei University Severance Hospital to develop diagnostic kits capable of simultaneously detecting BKV, EBV, and CMV.In the United States, the company is working with UNT Children’s Medical Center to develop molecular diagnostic kits for RSV and secondary infections. This content is partially excerpted from a news article. Source: https://www.mdtoday.co.kr/mdtoday/index.html?no=369173
HeimBiotek, Successful Development of Companion Diagnostic for Anticancer Drug Irinotecan
HeimBiotek, Successful Development of Companion Diagnostic for Anticancer Drug Irinotecan HeimBiotek announced on the 1st that it has successfully developed a companion diagnostic (CDx) for irinotecan, the most prescribed anticancer drug for solid tumors in cancer patients, utilizing Specific Bi-Direction-Extension (SBDE) technology. The newly developed CDx kit for irinotecan allows simultaneous detection and analysis of the heterozygous and homozygous forms of patient gene ‘UGT1A1’ variants *6 (SNP) and *28 (TA repeat sequence variation) in a single PCR tube, a global first. Irinotecan is commonly prescribed for cancers such as gastric, lung, and colorectal cancers, but dosing and prescription must consider the patient’s genotype. Patients with genotypes that can cause adverse reactions to irinotecan may experience severe diarrhea due to damage to the intestinal mucosa post-drug administration, and in some cases, may even lead to sepsis and death. A representative from HeimBiotek explained, “Incorrect administration of irinotecan can tragically result in patients suffering fatal adverse effects from the drug they received to treat their cancer, highlighting an ironic situation.” They added, “For this reason, the US FDA and European CE recommend companion diagnostics through UGT1A1 gene analysis before prescribing irinotecan.” Furthermore, they emphasized, “HeimBiotek now offers a much simpler and cost-effective method for irinotecan companion diagnostics compared to traditional parallel experimental analysis using multiple PCR tubes or genetic sequencing methods.” This content is partially excerpted from a news article. Source: https://www.mdtoday.co.kr/mdtoday/index.html?no=322747
HeimBiotek and Kyung Hee University Hospital at Gangdong Collaborate on BK Virus Diagnostic Kit Research
HeimBiotek and Kyung Hee University Hospital at Gangdong Collaborate on BK Virus Diagnostic Kit Research Kyung Hee University Hospital at Gangdong has signed a collaborative research agreement with HeimBiotek for developing a diagnostic kit for BK virus. The BK virus, named after a patient in 1971, is a virus that causes renal dysfunction and transplant kidney loss in kidney transplant recipients. Patients who undergo kidney transplantation should undergo regular screening to suppress early activation of BKV (BK virus infection) because it is crucial. Previously, diagnosis was invasive via blood tests, but this joint research aims to enable easy and rapid diagnosis through urine tests, a non-invasive method. Director Kim Ki-Taek of Kyung Hee University Hospital at Gangdong stated, “Through this agreement, the diagnostic kit to be developed will be the world’s first BK virus diagnostic kit,” adding, “We will continue to enhance research capabilities with leading domestic companies to advance medical technology and contribute to public health.” This content is partially excerpted from a news article. Source: https://www.mdtoday.co.kr/mdtoday/index.html?no=322057
