LAMH Health Submits IPO Prospectus Following Global First Approval of Liver Cancer Methylation Detection Kit

China has a high incidence of liver cancer. According to Globocan 2020 data, China accounted for nearly half of the global incidence and mortality rates of primary liver cancer in 2020. Liver cancer has an insidious onset with nonspecific early symptoms but progresses rapidly. Consequently, 80% of patients in China are diagnosed at an advanced stage or with distant metastasis, missing the opportunity for curative surgery. These patients have a poor prognosis, with a median survival time of less than 12 months. Therefore, early prevention, early detection, and early treatment of liver cancer are crucial.

LAMH has collaborated with multiple top-tier cancer centers, universities, and their affiliated hospitals, publishing relevant research findings in prestigious international journals such as Nature, Science, Cell and its subsidiary journals, and PNAS. It has established a comprehensive product pipeline for the early screening and diagnosis of liver cancer, colorectal cancer, lung cancer, and pan-cancer types. Leveraging AI-driven technologies combined with genomics and clinical medical theories, LAMH is dedicated to providing users with early cancer screening solutions. On June 20, 2023, LAMH obtained the Class III medical device registration certificate for the world’s first methylation detection kit for liver cancer.

On Tuesday, September 19, at 16:00, the 28th edition of VCBeat Select New Product Appreciation invitesLong Hao, Product Director at Laimeng Health, and Zhao Yanping, Deputy Product DirectorPresenting the promotion of “【Ganbeikang】The World’s First Methylation Detection Kit for Liver Cancer”

BMPR1A/PLAC8 Gene Methylation Detection Kit (Digital PCR Method) detects the methylation levels of liver cancer-associated BMPR1A/PLAC8 genes in human blood cell-free DNA (cfDNA), thereby identifying hepatocellular carcinoma and combined hepatocellular-cholangiocarcinoma. The entire process is non-invasive and painless, with objective and accurate test results.

First, cell-free DNA (cfDNA) is extracted from the subject's blood. Following methylation processing, digital PCR is performed to assess the methylation levels of the BMPR1A and PLAC8 gene regions. The methylation levels of these two genes are then analyzed to generate a corresponding diagnostic report. The test demonstrates a sensitivity of 95.42% and a specificity of 96.02% for detecting hepatocellular carcinoma and combined hepatocellular-cholangiocarcinoma.

1. Pioneered the first multicenter study in China on cfDNA methylation detection for liver cancer, with findings published in Nature Materials (impact factor: 43.8), the highest in the field.

2. For patients in whom imaging cannot provide a definitive diagnosis, particularly those with hepatocellular carcinoma lacking typical imaging features, the test demonstrated a sensitivity of 95.92%, a specificity of 93.62%, and an overall agreement rate of 94.79%.

3. The world's first NMPA-approved methylation detection kit for liver cancer, with registration certificate number: National Medical Device Registration No. 20233400836;

4. Excellent performance in early-stage hepatocellular carcinoma (HCC) detection, with an overall diagnostic sensitivity of 95.42%. The sensitivity for Stage I HCC was 93.8%, and reached 93.55% for tumors smaller than 2 cm. The overall specificity was 96.02%.

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Longhao

Product Director, LAMH Health

• Managed tumor early screening products and promoted their clinical adoption at multiple companies specializing in early cancer detection.

• Responsible for multi-center clinical trials and clinical promotion of products for benign/malignant diagnosis of pulmonary nodules and early screening of colorectal cancer, as well as product development and clinical promotion of early screening and diagnosis solutions for liver cancer.

Zhao Yanping

LAMH Deputy Product Director

• Biotechnology Background of the Genetic Testing Industry

• 8 Years of Experience in the Field of NGS-Based Cancer Testing

• Possesses extensive experience in sales, marketing, and product management.

• Focused on the field of early cancer screening, responsible for the management and promotion of products for liver cancer, colorectal cancer, lung cancer, and multi-cancer detection, and established strong connections with hospitals and experts in the oncology sector.

LAMH (Laboratory for Advanced Medicine & Health Group) is an innovative enterprise dedicated to AI-driven early screening and diagnosis of cancer. It was co-founded by international business leaders, top-tier scientists, and medical professionals, adhering to the philosophy of “making cancer early screening earlier, more accurate, more accessible, and simpler.” LAMH is the “world’s first and only” cancer early screening and diagnostics company with full-scale capabilities in technology development, manufacturing, NMPA/FDA regulatory approval, and commercialization in both China and the United States, the world’s two largest economies.

"Artery Select New Product Showcase" is a live-streaming program under the "Artery Select" brand, dedicated to supporting healthcare companies in launching innovative products. The program's mission is: to empower the milestone launch of every medical innovation product.

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