Helio Health, a Subsidiary of LAMH Group, Launches Commercial Liver Cancer Screening Test in the U.S., Becoming the First Company to Achieve Dual Commercialization in Both China and the U.S.

As an independently operated U.S. subsidiary of LAMH Group (Laboratory for Advanced Medicine & Helio Health Group), Helio Health announced the official commercial launch of Helio Liver™ in the United States on December 6. Helio Liver™ is a multiplex blood assay for detecting hepatocellular carcinoma, analyzing both cfDNA methylation and serum protein biomarkers.

Mr. Zhang Zeyue, Chairman and CEO of LAMH China, stated, “The official commercial launch of the Helio Liver™ early liver cancer screening test in the United States marks a milestone. Coupled with the formal large-scale commercial promotion in China starting in Q3 of this year, LAMH has become the first company globally in the early cancer screening sector to successfully achieve commercialization in both China and the United States.”

Zhang Zeyue stated, “In 2019, LAMH’s liver cancer methylation product became the first from a Chinese early-screening company to receive the U.S. FDA Breakthrough Medical Device designation. At last month’s AASLD (American Association for the Study of Liver Diseases) Annual Meeting, LAMH was also the only company to present data on early screening for liver cancer. The official launch of this commercialized test further solidifies LAMH’s global technological and commercial leadership in the field of early liver cancer screening. Prerequisites for launching commercial testing in the U.S. cancer early-screening market include excellent data performance and product efficacy, subject to extremely stringent requirements. The United States imposes strict regulatory standards on Laboratory Developed Tests (LDTs), with requirements for product performance verification and validation, as well as quality control, that are no less rigorous than those for In Vitro Diagnostics (IVD). Meanwhile, the provision of commercial testing services in the U.S. demands exceptionally high standards in a company’s front-, mid-, and back-office operational capabilities, as well as its commercialization strategy. This launch represents a concentrated demonstration of LAMH’s technological prowess and commercialization capabilities in cancer early screening.”

Since LAMH officially launched large-scale commercial promotion of its early liver cancer screening test in China in Q3 this year, the company has expanded its commercialization team and rapidly achieved strong commercial results. During this year’s “Double 11” online shopping festival, LAMH ranked second in sales across all cancer early screening categories and first in the liver cancer early screening category. Meanwhile, the clinical trial completed by the company at the end of last year demonstrated a sensitivity of 92.5% and a specificity of 97.5%. The regulatory approval process is progressing smoothly, and the company is expected to soon obtain the first Class III in vitro diagnostic (IVD) certificate for liver cancer methylation detection.

Helio Liver™ is capable of detecting hepatocellular carcinoma (HCC) at a very early stage, when lesions are often too small to be identified by conventional imaging modalities. Early detection of liver cancer allows for ample curative treatment options, resulting in a five-year survival rate for early-stage patients that is 13 times higher than that of patients with late-stage metastatic disease¹'². Reportedly, Helio Liver™ received enthusiastic orders from healthcare professionals in the United States within one hour of its launch, underscoring the urgent demand in the U.S. market for breakthrough technologies in early liver cancer screening.

“We are thrilled to provide a convenient and sensitive method for cancer detection to individuals at high risk for liver cancer. We are honored to introduce this non-invasive, convenient, and reliable test—a method that has the potential to redefine cancer screening and benefit more cancer patients in the future.”

——Justin Chen Li, CEO of Helio Health

Helio Liver™ requires only a single blood draw, offers simple operation, and can be integrated into routine check-ups. It provides a rapid and accurate method for regular monitoring of individuals at high risk for liver cancer. Although the AASLD guidelines recommend biannual ultrasound screening for high-risk populations, studies have shown that due to the inconvenience associated with ultrasound examinations, only 20% of individuals actually undergo such regular monitoring5.

“Through our partnership with Helio, we are jointly prioritizing the launch of Helio Liver to suppliers and patients. We have a strong commercial foundation and are prepared to provide first-class service to suppliers throughout the process, making it very easy for them to engage with us.”

— Brandon Perthui, Chief Commercial Officer at Fulgent Genetics

LAMH (Laboratory for Advanced Medicine & Helio Health Group) is an AI-driven healthcare company focused on commercializing early cancer detection through simple blood tests. The company’s mission is to simplify cancer screening, making it more accurate, earlier, and easier. Leveraging LAMH’s AI-driven technology, both physicians and their patients can gain powerful insights from more accurate, earlier, and more convenient blood test results.

Helio Health, a U.S.-based entity headquartered in Irvine, California, operates a CLIA- and CAP-certified laboratory in Indiana.

LAMH (Laboratory for Advanced Medicine & Health), a Chinese entity headquartered in the Beijing Economic-Technological Development Area, operates a third-party clinical laboratory (ICL) compliant with PCR and NGS standards on Guangzhou International Bio Island, and an IVD GMP-certified manufacturing facility in Guangzhou Science City that has passed the NMPA system assessment.

LAMH Group conducts full-scale R&D, manufacturing, regulatory approval, laboratory operations, and commercialization in both China and the United States, the world’s two largest economies. Leveraging its robust R&D infrastructure, LAMH Group completed registration clinical trials in China by the end of 2020, while enrollment for its U.S. clinical trials has progressed rapidly, securing a leading position in the field of early liver cancer screening. LAMH Group’s product pipeline also covers pan-cancer detection, as well as colorectal, breast, and lung cancers.

1 Yu, N. C., Chaudhari, V., Raman, S. S., et al. CT and MRI improve detection of hepatocellular carcinoma, compared with ultrasound alone, in patients with cirrhosis. Clinical Gastroenterology and Hepatology. 2011;9(2):161-167.

2 National Cancer Institute: Cancer Stat Facts – Liver and Intrahepatic Bile Duct Cancer. Available at: https://seer.cancer.gov/statfacts/html/livibd.html [accessed November 30, 2021]

3 Lin N, Lin Y, Xu J, et al. A multi-analyte blood test for accurate and early detection of hepatocellular carcinoma. Poster presented at: American Association for the Study of Liver Diseases – The Liver Meeting; November 12-15, 2021; Virtual.

4 Tzartzeva K, Obi J, Rich NE, et al. Surveillance Imaging and Alpha Fetoprotein for Early Detection of Hepatocellular Carcinoma in Patients With Cirrhosis: A Meta-analysis. Gastroenterology. 2018;154(6):1706-1718.e1. doi:10.1053/j.gastro.2018.01.064

5 Wang C, Chen V, Vu V, et al. Poor adherence and low persistency rates for hepatocellular carcinoma surveillance in patients with chronic hepatitis B. Medicine (Baltimore). 2016;95(35):e4744. doi:10.1097/MD.0000000000004744