Laboratory for Advanced Medicine & Health

LAMH is an Al-driven cancer screening and diagnostic innovation enter- prise, founded by international business leaders, top scientists and medical professionals, with the idea of "making cancer screening earlier, more accurate,more accessible and easierLAMH is the "Global first and only" early cancer screening and di- agnostic company that is fully established in China and the United States, the world's two largest economies, for technology de- velopment,manufacturing,NMPA/FDA approval and commercialization.On June 20.2023.Guangzhou Elitehealth Biotech Co.LTD.a GMP entity of LAMH, accomplished a remarkable milestone by obtaining the world's first (and currently the only)registration certificate for liver cancer early screening from the China National Medical Products Administration(NMPA).The Company successfully launched its liver cancer early screening products,甘倍康and HelioLiver in China and the U.S. respectivelyproviding accurate, accessible,and user-friendly screening and diagnostic solutions for liver cancer. This groundbreaking achievement has revolutionized the landscape of clinical screening, diagnosis, and monitoring of liver cancer, thereby establishing and enhancing the standards and protocols for cancer screening in both coun- tries. By adopting a value-based medicine approach, the company aims to address the challenges associated with early cancer screening,diagnosis, and treatment. effectively meeting the unmet clinical and health needs in both China and the United States.

The Chinese independent entity LAMH is headquartered in the Pazhou Central Business District, Guangzhou. It has a research and registration center in the Beijing Economic and Technological Development Zone, Southern and Northern medical testing labs (ICL) compliant with PCR and NGS standards in Guangzhou's Biotech Island and Beijing's Yizhuang respectively. A NMPA-assessed IVD GMP factory is located in Guangzhou's Science City. The American independent entity Helio Genomics is based in Irvine, California, with a certified CLIA and CAP central lab in Indiana.

Mission

Making cancer screening earlier,

more accurate, accessible and convenient.

Vision

A technology-driven global leader

in early cancer detection.

Values

Result-oriented, customer-centric,

and people-oriented.

Core Technology
A technology-driven global leader in early cancer detection.
The world's first large scale liver cancer early screening research results based on cfDNA methylation technology, pioneering the use of cfDNA methylation for early cancer screening.
LAMH research results show that methylation markers can be used effectively in the diagnosis and prognosis of breast, colorectal, liver and lung cancers.
CHALM-cell heterogeneity-adjusted methylation quantitative analysis method.
Research published in the Journal of the American Association for the Study of Liver Cancer has shown that the LAMH HelioLiver Test, a liver cancer early screening product, can accurately detect early stage liver cancer.
Product
早诊精准解决方案
IvyGene® Liver
Hepatocellular carcinoma gene
methylation test
IvyGene®Liver Plus
Hepatocellular carcinoma gene
methylation test
lvyGene® PLUS
Early and accurate cancer screening
Company History
2010
The world's earliest methylation technology company
Obtains UCSD's global first methylation cancer screening technology.
2015
LAMH was officially established.
2016
Granted PCT patent
Including methylation markers for solid tumors, colorectal cancer, lung cancer, leukemia, breast cancer, ovarian cancer, and liver cancer.
2017
Granted Chinese patents
For methylation markers for diagnosing liver cancer and lung cancer, as well as methylation markers for cancer diagnosis.
2018
Completed NMPA registration for liver cancer detection
Becoming the first company to pass China's liver cancer methylation detection IVD registration.
2019
The first to launch China's NMPA liver cancer clinical trial
Receive a major project from the Ministry of Science and Technology of China
And jointly develop Chinese population-based liver cancer, colorectal cancer, and lung cancer screening standards and technical routes.
2020
Completed NMPA liver cancer clinical trial and releases clinical trial data.
2021
Completed product standardization for colorectal cancer early screening
multi-omics blood products by PCR laboratory acceptance.
2021
Commercialization of liver cancer products officially launches.
LAMH launches commercialization of scale liver cancer LDT testing products
Pan-cancer early screening multi-omics blood products marker screening
and five-cancer early screening LDT products launched
2022
Launches MR liver cancer recurrence monitoring project.
LAMH was recognized as the first batch of "National High-tech Enterprises" in 2022.
History
全球最早甲基化技术公司
莱盟健康LAMH通过UCSD全球首创甲基化癌症筛查技术
莱盟健康LAMH正式成立
获授PCT专利
包括实体肿瘤、结肠癌、肺癌、白血病、乳腺癌和卵巢癌、肝癌甲基化标记物及其用途
获授中国专利
用于诊断干细胞癌和肺癌甲基化的甲基化标记物、用于癌症诊断的甲基化标记物
肝癌NMPA注册检完成
全球首家通过中国肝癌甲基化检测IVD
注册检的企业
首家启动中国NMPA肝癌临床试验
获得中国科技部重大专项
与国家癌症中心NCC共同获得科技部重大
专项
完成NMPA中国肝癌临床试验
发布肝癌NMPA临床试验数据
通过PCR实验室验收
肠癌早筛多组学血液产品定型
中国肝癌产品商业化
正式启动中国肝癌LDT检测产品规模化
商业化
泛癌种早筛多组学血液产品marker筛选
五癌种早筛LDT产品启动
莱盟健康LAMH MR肝癌复发监测项目启动
莱盟健康LAMH获2022年度首批“国家高新技术企业”认定
Cutting-edge cooperation
Stanford Medicine
Johns Hopkins
Harvard Medical School
Cleveland Clinic
UCI Rvine
Uc San Diego
Purdue University
University Of Arizona
U Health
Moffitt Cancer Center
Ochsner Health
Cedars Sinai
Listed in no particular order
《Nature Materials》
Researchers analyzed ctDNA methylation models of 1098 liver cancer patients and 835 normal individuals, and established integrated diagnostic models (AUC: 0.969) and comprehensive prognostic models with 10 and 8 methylation sites, respectively, which possess high sensitivity and specificity. These models were used for real-time tumor load detection, treatment response, recurrence monitoring and prognosis evaluation of liver cancer patients. Compared with AFP detection, the integrated diagnostic model has higher sensitivity and specificity in stages I, II, and III tumors, while AFP does not change much except in stages III and IV liver cancer.
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《PNAS》
Researchers used AI training on methylation data from TCGA and Chinese clinical samples in NGS technology, and screened out specific methylation models for four common cancers (breast cancer, colorectal cancer, liver cancer, and lung cancer). The verification results showed that the methylation model can detect the four types of cancer with an accuracy rate of over 95% in the Chinese population.
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《Nature Communications》
The current methylation quantitative analysis method does not consider the heterogeneity of cells during sequencing, which may lead to weak correlation between methylation analysis results and gene expression data. The CHALM algorithm helps us better reveal the function of DNA methylation and its correlation with gene expression.
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《Nature Materials》
HelioLiver Test is a blood test that combines cfDNA methylation patterns with tumor protein markers analysis. In a double-blind, multi-center clinical validation study of 122 liver cancer patients and 125 cirrhosis patients, HelioLiver Test had a sensitivity of 85% for detecting liver cancer, and 76% for early-stage (AJCC I and II) liver cancer, while the specificity was also up to 91%, which is significantly better than AFP and GALAD models.
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