Liquid Biopsy Assay Demonstrates High Accuracy for Detection of Hepatocellular Carcinoma

New data showed the Helio Liver Test, a liquid biopsy assay, demonstrated high accuracy and screening value of this cell-free DNA (cfDNA) methylation blood-based assay for the detection of hepatocellular carcinoma (HCC), Helio Health, an AI-driven company focused on early cancer detection tests and developer of this blood-based assay, announced in a press release.¹

These findings were presented during a poster at the virtual 2020 Annual Meeting of the American Association for the Study of Liver Diseases, which was held virtually November 13-16, 2020, suggesting the Helio Liver Test could provide, compared with the current screening modalities, greater sensitivity, and specificity for the detection of early-stage HCC and disease surveillance among high-risk patients.

"Patients with HCC suffer from high mortality, often associated with poor rates of early detection. There is a significant unmet need to advance standard surveillance methods for this disease and also improve adherence to screenings and subsequent surveillance for those at high risk of HCC," said Robert Gish, MD, clinical professor of Medicine at Loma Linda University Medical Center, University of Nevada Las Vegas, University of Nevada Reno, and Medical Director of the Hepatitis B Foundation, in a statement.

Together with protein markers and demographics, the multi-analyte HCC-specific liquid biopsy was validated in an independent cohort, which included 631 total patients, 291 of whom had HCC, and 340 were age-matched controls. The test was compared with serum alpha-fetoprotein (AFP) alone, which is a well-known marker for HCC.

The Helio Liver Test had 88.7% sensitivity (95% CI, 87.3%-90.0%) in early-stage disease of stage 1 and 2 compared with 57.5% sensitivity (95% CI, 52.6%-61.8%) with AFP alone. The current standard of care for the detection of early-stage disease is ultrasound, which has approximately 47% sensitivity (95% CI, 33%-61%).

"Liver cancer is 1 of the fastest growing and deadliest cancers worldwide and early detection is critical to successful outcomes, especially among high-risk populations. These positive data provide further evidence of the Helio Liver Test's ability to provide earlier detection with greater accuracy for liver cancer and enable groundbreaking advances in the detection and management of this growing disease," stated Kenneth Chahine, PhD, JD, chief executive officer of Helio Health. "We look forward to advancing development of this important and easy to use test as we work to make it available to patients and healthcare providers who currently have limited options for accurate and sensitive early-stage detection."

HCC is known as the fifth most common, as well as the second deadliest, cancer across the globe. With the development of more personalized therapeutic approaches in the HCC treatment landscape, the role of biopsies for genetic analysis is becoming increasingly important.²

Surgical resection of the tumor plays an important role in the treatment of patients with HCC, but the fact that many patients also have cirrhosis complicates the therapeutic approach to these patients. A multidisciplinary team is needed to manage these patients. Alternative treatment approaches include different types of locoregional therapy, immunotherapy, targeted therapy, and chemotherapy.

_References

_{1. Positive data presented on helio health liver test for the detection of hepatocellular carcinoma (HCC) advances product development. Helio Health. November 13, 2020. Accessed November 16, 2020.}

_{2. What is Hepatocellular Carcinoma (HCC)? Mount Sinai. Accessed November 5, 2020. Mountsinai.org/care/cancer/services/liver/hepatocellular-carcinoma.}