News

Apr 28

Helio Health and National Cancer Center Awarded Grant from Ministry of Science and Technology to Evaluate Helio Liver Test in Real-World Screening Scenario in China

Strategic partnership with NCC enables accelerated development of its Helio Liver Test for early liver cancer detection and screening

IRVINE, Calif., April 28, 2021 – Helio Health, an AI-driven healthcare company focused on commercializing early cancer detection tests from a simple blood draw, today announced that it was awarded a grant in partnership with the National Cancer Center (NCC) from the Ministry of Science and Technology of China, which will enable accelerated development of its Helio Liver Test, the Company’s first blood test designed for the early detection of HCC or liver cancer.

This award and strategic partnership with the NCC, a national organization that leads cancer prevention and control programs and sets cancer treatment guidelines in China, will support a study evaluating the performance of the Helio Liver Test in real-world screening scenarios. The prospective and blinded study will measure 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. The study is currently enrolling subjects at Jiangsu Provincial Center for Disease Control and Prevention.

“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 charactertistics 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,” said Kenneth Chahine, Ph.D., J.D., Chief Executive Officer of Helio Health.

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 undergo survaliance screening every six months.[1],[2],[3] Early detection of liver cancer is critical to successful outcomes with a survival rate that is 12 times higher if caught in early versus late stages.[4]

About the Helio Liver Test

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).

About Helio Health

Helio Health is an AI-driven healthcare company focused on commercializing early cancer detection tests from a simple blood draw. The company’s mission is to simplify cancer screening so lives can be saved by detecting cancer earlier. With Helio’s AI-driven technology, both physicians and their patients gain powerful insights from accurate, accessible, and convenient blood tests.

Building on a robust research and development program, and with access to thousands of patient samples, the company is currently in clinical trials in the US and China with its lead liver cancer detection test. Helio’s development program is focused on liver, colon, breast and lung cancer.

Helio Health is headquartered in Irvine, CA, with R&D, GMP and CLIA facilities in Irvine, CA and West Lafayette, IN, Guangzhou and Beijing.

 

Media

Terri Clevenger

Westwicke/ICR

Terri.clevenger@westwicke.com

(203) 856-4326

 

Investors

Mike Cavanaugh

Westwicke/ICR

Mike.Cavanaugh@westwicke.com

(646) 877-9641

 

[1] World Health Organization: Globocan 2020 – China Factsheet. Available at: http://gco.iarc.fr/today/data/factsheets/populations/160-china-fact-sheets.pdf [accessed March 5, 2021]

[2] World Health Organization: Up to 10 million people in China could die from chronic hepatitis by 2030 – Urgent action needed to bring an end to the ‘silent epidemic.’ Available at: https://www.who.int/china/news/detail/26-07-2016-up-to-10-million-people-in-china-could-die-from-chronic-hepatitis-by-2030-urgent-action-needed-to-bring-an-end-to-the-silent-epidemic- [accessed March 5, 2021]

[3] World Health Organization: Hepatitis B. Available at: https://www.who.int/news-room/fact-sheets/detail/hepatitis-b [accessed March 5, 2021]

[4] National Cancer Institute: Cancer Stat Facts – Liver and Intrahepatic Bile Duct Cancer. Available at: https://seer.cancer.gov/statfacts/html/livibd.html [accessed March 8, 2021]