Irvine California Venture Inks Deal with China’s National Cancer Center to Study Cancer Detection Test Starting with Liver Cancer

Irvine California Venture Inks Deal with China’s National Cancer Center to Study Cancer Detection Test Starting with Liver Cancer

An Orange County, California-based venture commercializing an AI-based, early cancer detection test from a simple blood draw recently announced they received a strategically important grant award in partnership with the National Cancer Center (NCC) from the Ministry of Science and Technology of China. The Chinese government money will help support the accelerated development of the Helio Liver Test, Helio Health’s first blood test designed for the early detection of HCC or liver cancer. This award and bundled partnership with China’s national cancer research organization, the NCC, supports the investigation into the performance of the Helio Liver Test in real-world screening scenarios.

The Study at Jiangsu Provincial Center for Disease Control and Prevention

This grant essentially funds a China-based prospective and blinded study measuring the sensitivity and specificity of the Helio Liver Test compared with current standards of care for the detection of liver cancer in approximately 3,000 subjects in China. This study is now actively enrolling subjects at Jiangsu Provincial Center for Disease Control and Prevention.

The Challenge

Liver cancer is the fastest growing and second deadliest cancer worldwide. In China alone, there are more than 400,000 liver cancer diagnoses each year and nearly 100 million people in China are living with hepatitis B virus (HBV), which significantly increases the risk of liver cancer; and global guidelines, including in the U.S. and China, recommend undergoing surveillance screening every six months. Early detection of liver cancer is critical to successful outcomes with a survival rate that is 12 times higher if caught in the early versus late stages as reported by the National Cancer Institute (NCI).

Helio Health Point of View

The Chief Executive Officer of Helio Health, Kenneth Chahine, PhD, JD, went on the record in a recent press release: “We are excited to receive this award from the NCC and partner with the leading cancer institute in China as we gather evidence on the Helio Liver Test’s early detection and screening performance characteristics in a real-world screening setting. This particular study is uniquely designed to evaluate the test in a larger screening population and will allow us to gain a better understanding of the real-world application for this important technology, including across rural parts of China where access to cancer detection and screening tests is often limited.”

The Partner/Grant Source

The National Cancer Center in China (NCC) is a governmental organization much like the U.S.-based NCI. Founded in 1958 in Beijing, China, they employ about 2,317 and manage and maintain a hospital with 1,291 beds. The NCC actively funds and supports cancer research, including a range of activities from assisting the National Health Commission of China in formulating the National Cancer Prevention and Control Plans to establishing a national cancer prevention and control collaborative network, organizing and executing cancer registration and other data collection and management activities. They also draw up technical specifications and relevant standards for cancer diagnosis and treatment and carry out scientific and translational research on cancer prevention and control.

The Investigational Product

The Helio Liver Test is a cell-free DNA (cfDNA) methylation blood-based assay that can be conducted from a simple blood draw and is designed for the early detection of hepatocellular carcinoma (HCC), or liver cancer. Data presented in November 2020 suggest that the Helio Liver Test may provide greater sensitivity and specificity for the detection of early-stage (stages 1 and 2) HCC and disease surveillance in a high-risk population compared to current screening modalities. Results showed that the Helio Liver Test produced 88.7% sensitivity in early-stage HCC, while sensitivity for AFP, a well-known marker for liver cancer, alone was 57.5%. Ultrasound, the current standard of care for early-stage HCC detection, has approximately 47% sensitivity. The Helio Liver Test is currently being evaluated in a U.S. multi-center, prospective clinical trial and is also under regulatory review for registration by the China National Medical Products Administration (NMPA).

The Company

Headquartered in Irvine, CA, Helio Health has set up research and development, and manufacturing and lab facilities in Irvine; West Lafayette, IN; as well as Guangzhou and Beijing, China. An AI-driven healthcare company, the company focuses on commercialization of early cancer detection tests from a simple blood draw. They are on a mission to simplify cancer screening so lives can be saved by detecting cancer earlier. The company positions that with their investigational AI-driven tests, both physicians and their patients gain powerful insights from accurate, accessible and convenient blood tests.

Founded in 2014, this venture has raised $86 million according to Crunchbase. This venture is also known as Laboratory for Advanced Medicine. CEO Kenneth Chahine, a Utah resident, also serves as a professor at University of Utah teaching new venture development and entrepreneurial law. He got into life sciences nearly 30 years ago as a patent attorney.

Dr. Richard Van Etten, Director of the Chao Family Comprehensive Cancer Center at UCI, serves the company as Chief Medical Officer

Back in 2020, they announced a new CEO for their China operation, Samuel Tong