近日，莱盟健康LAMH旗下的广州优泽生物技术有限公司研发生产的甘倍康获得欧盟CE认证，代表该产品的安全性和有效性符合欧盟相关的法律法规和标准的要求，可以在欧盟市场销售，进一步提升了莱盟健康LAMH产品的国际竞争力。
LAMH is pleased to announce that its subsidiary, Guangzhou Elitehealth Biotech Co., Ltd. has recently obtained the CE certification from the European Union for its flagship product, “Ganbeikang”. This certification signifies that the product meets the safety and efficacy requirements set forth by the relevant laws, regulations, and standards of the European Union. With this achievement, Ganbeikang is now authorized for sale in the European Union market, further enhancing the international competitiveness of LAMH’s product portfolio.
此次通过CE认证的产品甘倍康是通过检测人血液游离DNA（cfDNA）中肝癌相关基因甲基化水平，从而检测原发性肝细胞癌及混合癌，整个过程无创无痛，检测结果精准可靠，对于肝癌的检测灵敏度高达95.42%，I期肝癌灵敏度也可以达到93.79%，特异性高达96.02%。
Ganbeikang, the product that has obtained CE certification, is a non-invasive and painless testing method for the detection of primary hepatocellular carcinoma and mixed carcinoma. It achieves this by analyzing the methylation levels of liver cancer-related genes in circulating free DNA (cfDNA) extracted from human blood. The testing process is precise and reliable, with a high sensitivity of up to 95.42% for detecting liver cancer. Even in Stage I liver cancer, the sensitivity can reach 93.79%, with a high specificity of 96.02%.
莱盟健康LAMH成立于2015年，拥有国际PCT及中美66项发明专利，也是首个获得 FDA突破性医疗器械证书的中国癌症早筛早诊企业，并于2023年6月20日，莱盟集团 GMP实体公司广州优泽生物技术获得全球肝癌早筛早诊领域首个注册证书。其美国公司Helio则为全球首个/唯一获得美国肝癌早筛保险CPT代码及保险定价（660 美元/次，一年 2 次）的企业。公司在“2023未来医疗100强”的榜单估值为55亿元，董事长兼CEO张泽跃作为癌症早筛早诊领域唯一代表上榜2023《财富》“40 位 40 岁以下的商界精英”。
LAMH was established in 2015 and holds 66 international PCT and US/China patents. It is the first Chinese company to have obtained the FDA’s Breakthrough Device Certification for cancer early screening and diagnosis. On June 20, 2023, Guangzhou Elitehealth Biotech Co., Ltd., a GMP entity under LAMH Group, obtained the world’s first registration certificate for liver cancer early screening and diagnosis. Additionally, their US-based company, Helio, is the first and only enterprise globally to receive the CPT codes and insurance pricing (USD 660 per test, twice a year) for liver cancer early screening. LAMH has achieved significant recognition in the healthcare industry. The company was valued at 5.5 billion yuan and secured a position on the “2023 Future Medical Top 100” list. Furthermore, Zhang Zeyue, the Chairman and CEO, was listed, as the only representative from the cancer early screening and diagnosis field, in the “40 Under 40” elite business leaders by FORTUNE magazine in 2023.
莱盟健康LAMH董事长兼CEO张泽跃表示：“莱盟集团通过整合领先的全球创新技术和独特的中国临床资源优势，取得了在中美癌症早筛领域的领先，在今年6月获得了全球第一个肝癌早筛早诊证书，现在又获得欧盟CE认证。我们始终投入全球领先创新技术转化，实现更多癌症早筛早诊产品在全球的获批和商业化，同时会加大国际业务布局，持续拓展全球海外市场，以更好解决人类未被满足的临床及健康需求。”
LAMH Chairman and CEO, Zhang Zeyue, stated, “Through the integration of cutting-edge global innovative technologies and unique Chinese clinical resources, LAMH Group has achieved a leading position in the field of cancer early screening and diagnosis in both China and the United States. In June, 2023 we obtained the world’s first certificate for liver cancer early screening and diagnosis, and now we have also obtained the CE certification from the European Union. We are committed to investing in global leading innovative technology transfer, obtaining approvals and commercializing more cancer early screening and diagnosis products worldwide. Additionally, we will expand our international presence and continuously explore overseas markets to better address the unmet clinical and healthcare needs of humanity.”
