NEW YORK ─ Irvine, California-based Helio Health on Thursday announced a multicenter collaboration to compare the performance of its circulating tumor DNA assay with abbreviated magnetic resonance imaging and ultrasound for hepatocellular carcinoma (HCC) screening.
To compare the detection performance of the different screening modalities, Helio Health is co-sponsoring a prospective cross-sectional, single arm, non-randomized study, called FAST-MRI, which is funded by the US National Cancer Institute. Over four years, the study aims to enroll 820 patients with liver cirrhosis who are at risk of developing liver cancer. Four centers are participating in the study, including the Icahn School of Medicine at Mount Sinai in New York.
"The current standard for detecting early stages of hepatocellular carcinomas is lacking, as ultrasound is not sensitive enough," Bachir Taouli, the principal investigator of the FAST-MRI study and a professor at the Icahn School of Medicine, said in a statement. "In this study, we will be able to investigate novel liver cancer detection techniques, including a hepatobiliary phase abbreviated gadoxetate-MRI exam, as well as circulating tumor DNA liquid biopsies, against ultrasound to identify better screening options for patients."
Kenneth Chahine, CEO of Helio Health – formerly called Laboratory for Advanced Medicine – said the company's objective is to improve upon its liver test and further validate its performance and clinical utility. He noted that validations are already occurring in US and China-based prospective trials.