The Ministry of Science and Technology of China has awarded a grant to Helio Health and the Chinese National Cancer Center (NCC) to expedite the development of the Helio Liver Test for early identification of hepatocellular carcinoma (HCC) or liver cancer.
Helio will collaborate with the NCC to put the grant towards a study that will assess the performance of the blood test in real-world screening settings.
The Helio Liver Test is a cell-free DNA methylation blood-based assay, which can be carried out using a simple blood draw.
The prospective study will be blind and involve around 3,000 participants in China. It will evaluate the sensitivity and specificity of the Helio Liver Test versus existing standards of care for liver cancer detection.
It is currently enrolling participants at Jiangsu Provincial Center for Disease Control and Prevention.
Helio Health CEO Kenneth Chahine said: “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 Helio Liver Test is also currently undergoing analysis in a US multi-centre, prospective trial as well as being under regulatory review for registration by the China National Medical Products Administration.
According to data reported from a study in November last year, the test could potentially offer increased sensitivity and specificity versus existing screening modalities in detecting early-stage (stages 1 and 2) HCC and disease surveillance in high-risk groups.
The Helio Liver Test demonstrated a sensitivity of 88.7% in early-stage HCC, while sensitivity for AFP, a marker for liver cancer, was 57.5%. An existing standard of care for early-stage HCC detection, Ultrasound, showed a sensitivity of approximately 47%.