LAM-Helio Secures Hundreds of Millions in Funding, Surpassing RMB 1 Billion Total to Accelerate Dual-Market Commercialization and Regulatory Submissions in the U.S. and China
VCBeat has learned that LAM-Helio Group, committed to becoming a global leader in early cancer screening, recently announced the completion of a financing round worth hundreds of millions of yuan, bringing its cumulative fundraising to over RMB 1 billion. Investors include CAS Venture Capital, the CAS Fund of Funds, and Fulgent Genetics, a leading company in genetic testing. The funds will be used to build and strengthen the commercialization team and organizational structure for its liver cancer screening product, advance the clinical approval processes for its colorectal and lung cancer early screening products in both China and the United States, and accelerate the joint optimization of early screening technologies for lung cancer, colorectal cancer, and other cancers with the National Cancer Center.
LAM-Helio is a “"AI + Genomics"
LAM-HelioLeveraging leading patented methylation technologies and clinical resources, we have analyzed over 200,000 blood samples, covering 22 major cancer types.Published multiple landmark research findings in top-tier international journals such as Nature, Science, Cell, and PNAS, along with their affiliated journals, and established comprehensive product pipelines for the early screening and diagnosis of liver cancer, colorectal cancer, lung cancer, and pan-cancer types in both China and the United States.
China and the United States are the two largest markets for early cancer screening globally, with data showing that the market size in both countries exceeds $100 billion. Notably, LAM-Helio Group is commercializing its technologies and products in both countries simultaneously as an independent entity.It is the only global group enterprise to have independently established fully integrated teams for R&D, manufacturing, testing, regulatory approval, and commercialization in both China and the United States.Its pioneering early screening product for liver cancer was approved in early 2019U.S. FDA Breakthrough Device Designation; IVD certificates for ctDNA methylation in the field of liver cancer are currently under simultaneous regulatory review by the U.S. FDA and China's NMPA,Poised to become the first to obtain the world’s inaugural IVD certificate in the field of methylation testing for liver cancer.
Advanced-stage cancers are difficult to treat and associated with low survival rates; early diagnosis can significantly improve patient outcomes. It is reported that through early screening, early diagnosis, and early treatment, the 10-year survival rate for some patients with early-stage cancer can exceed 90%, whereas the 10-year survival rate for most patients with advanced-stage cancer remains below 5%.
Early cancer screening has become a prime sector, with surging industry and capital interest, broad development prospects, and numerous companies accelerating their strategic deployments. Among these, ctDNA methylation has emerged as the mainstream focus for companies in the molecular diagnostics field specializing in early cancer detection.
ctDNA refers to DNA fragments in the blood that carry cancer-related genetic variants and epigenetic information. Methylation changes within ctDNA can indicate cancer at an ultra-early stage of its onset and progression. Compared with circulating tumor cells (CTCs) and microRNAs (miRNAs), ctDNA methylation holds greater potential for development.
Zhang Zeyue, Partner and CEO of LAM-Helio in China, stated that achieving early cancer screening and diagnosis through methylation technology, and enhancing the sensitivity and specificity of early cancer detection, requires a robust foundation of large-scale sample training, as well as deep integration based on AI, genomics technologies, and clinical medicine.LAM-Helio leverages AI and bioinformatics technologies to better train and determine biomarker combinations, effectively enhancing detection sensitivity and specificity.
The LAM-Helio team boasts extensive expertise in AI and genomics. Dr. Li Shu, Founder and Chairman, holds a Ph.D. from Harvard University, conducts research in the field of artificial intelligence, and is a serial successful entrepreneur.Has founded and successfully taken three companies public.
Co-founder and Chief Scientific AdvisorProfessor Zhang Kang is the inventor of methylation technology,A globally renowned genomics expert, Professor Kang Zhang is the first individual from mainland China since the founding of the People's Republic of China to be awarded dual doctoral degrees: a Doctor of Medicine (M.D.) from Harvard University and a Doctor of Philosophy (Ph.D.) in Genetics from the Massachusetts Institute of Technology. From 2014 to 2019, he founded and served as Director of the Institute for Genomic Medicine at the University of California, San Diego (UCSD), Director of the Biomaterials & Tissue Engineering Center, and held the position of Tenured Full Professor of Human Genetics. In 2017, Professor Zhang published an article in Nature Materials on the detection of early-stage hepatocellular carcinoma via ctDNA methylation, which remains one of the most highly cited papers in the field of methylation to date.
Article published in Nature Communications by Professor Wei Li, Chief Bioinformatics Advisor at LAM-Helio and Chair of the Department of Bioinformatics at UCI: The patented method for Clonal Heterogeneity-Adjusted Local Methylation (CHALM) has been incorporated into the company’s DNA methylation prediction model.
By integrating AI with genomics technologies, LAM-Helio selected millions of DNA methylation sites as potential biomarkers, from which it identified the 3,000 sites exhibiting the greatest differential methylation between the blood of cancer patients and that of healthy individuals. This finding was validated across nearly hundreds of thousands of samples, leading to the development of early-screening products for multiple cancer types. Consequently, LAM-Helio has established a comprehensive product pipeline for the early screening and diagnosis of liver cancer, colorectal cancer, lung cancer, and pan-cancer indications, thereby ensuring the analytical accuracy of its tests.
Targeting the cancer early screening sector, LAM-Helio has implemented a comprehensive product portfolio, developing multiple solutions for early detection of liver cancer, colorectal cancer, lung cancer, and pan-cancer screening.
Among these, early screening for liver cancer is the fastest-developing and most advanced product under LAM-Helio.
The global market for liver cancer diagnosis and treatment is substantial and continues to grow year by year. Liver cancer ranks sixth in incidence among all malignant tumors worldwide, and the World Health Organization estimates that annual deaths from liver cancer will exceed 1 million by 2030.
As a country with a high prevalence of hepatitis B, China faces a particularly severe situation in the prevention and control of liver cancer. The target high-risk populations for early screening of liver cancer include individuals infected with hepatitis B, those with cirrhosis, fatty liver disease (including both alcoholic and non-alcoholic fatty liver), and those with a family history of liver cancer, totaling over 200 million people who are at significantly increased risk of developing liver cancer. According to the latest 2020 global cancer burden data released by the International Agency for Research on Cancer (IARC) of the World Health Organization, the incidence of liver cancer in China accounts for approximately 9% of all cancer cases, ranking fifth.
Currently, there is a lack of effective products for early screening of liver cancer in clinical practice. The primary methods for early liver cancer screening are ultrasound and AFP testing. It is reported that the sensitivity of ultrasound examination is only 45%, with approximately 20% for very early-stage cancers. The combined sensitivity of ultrasound and AFP testing is merely 51%.
LAM-Helio has accumulated over 40,000 biological samples in the field of liver cancer detection and has developed a highly accurate, cost-effective, and user-friendly product for early liver cancer screening using digital PCR and NGS platforms.This product enables early detection of liver cancer by assessing the methylation levels of cell-free DNA (cfDNA) in blood. By leveraging the quantitative capabilities of digital PCR and next-generation sequencing (NGS), it ensures both sensitivity and specificity while controlling testing costs.
It is understood that among thousands of subjects in China,LAM-Helio's liver cancer early screening product has a sensitivity of 92% and a specificity of 97%,Its accuracy is significantly superior to that of traditional detection methods such as ultrasound and AFP. In the United States, LAM-Helio’s early liver cancer screening product has received the FDA Breakthrough Device Designation, and patient enrollment for its FDA-regulated in vitro diagnostic (IVD) clinical trial for early liver cancer screening is progressing rapidly.The company is poised to obtain the first IVD certificate in the global field of liver cancer methylation testing.
Furthermore, LAM-Helio’s early screening products for colorectal cancer, lung cancer, and pan-cancer are under continuous development. Notably, the colorectal cancer early screening technology has been published in Science. Data from a prospective study involving 1,493 participants demonstrated that this colorectal cancer detection product achieved a sensitivity of 90% and a specificity of 85%. Unlike conventional stool-based tests currently available on the market, this technology employs blood samples for methylation detection.
Leveraging its leading technological advantages and comprehensive product portfolio in the field of early cancer screening, LAM-Helio has established strategic collaborations with Sun Yat-sen University Cancer Center, the National Cancer Center, Ping An Insurance, Fulgent Genetics, the Keck Medical Center of USC, and Mount Sinai Hospital. Furthermore, as a technology provider participating in the National Key R&D Program of the Ministry of Science and Technology, LAM-Helio has significantly strengthened its global research and development and commercialization capabilities.
Zhang Zeyue stated: “Accuracy, simplicity, speed, and cost-effectiveness have always been the development directions for cancer early screening products.“The Company places great emphasis on the successful productization and commercialization of its technological achievements, striving to become a global leader in the field of early cancer screening.” Moving forward, LAM-Helio will continue to deepen its expertise in early cancer screening along these key strategic directions, accelerating clinical registration studies and regulatory approvals for its early screening and diagnostic products for liver cancer, colorectal cancer, lung cancer, and pan-cancer indications in both China and the United States, leveraging technology to enable early cancer detection and save lives.