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The HelioLiver test

Check for liver cancer with a simple blood draw.

The HelioLiver test

Check for liver cancer with a simple blood draw.

Detect cancer with a simple blood draw

HelioLiver is a multi analyte blood test that evaluates cell free DNA (cfDNA) methylation patterns, serum protein markers, and demographic information for the detection of hepatocellular carcinoma (HCC) - the most common form of liver cancer.

Early detection improves survival

For at risk patients, getting tested every 6 months is critical to discovering the cancer as early as possible, when it can still be cured.

Patients with liver cirrhosis and chronic hepatitis B are at high risk for HCC and are recommended for surveillance every 6 months by the American Association for the Study of Liver Diseases (AASLD).

Major causes of cirrhosis include Hepatitis B, Hepatitis C, excessive alcohol use, obesity, diabetes, and nonalcoholic fatty liver disease (NAFLD).

Early-Stage Patients Have Better Outcomes & More Treatment Options

Early-stage Liver Cancer

>70% Survival at 5 Years

Resection (Partial Hepatectomy)
Microwave Ablation
Nuclear Ablation
Targeted Therapies
Radioembolization (Y90)
Transplant

Late-stage Liver Cancer

Median Survival <1.5 Years

Chemotherapy
Late-stage Drugs
Palliative Therapy

For symptomatic advanced stage cases treated with systemic therapies. https://www.nature.com/articles/s41572-020-00240-3

Elevating the standard of care

Ultrasound is the standard of care for liver surveillance, yet is widely perceived by physicians as inadequate, owing both to performance factors and barriers to patients receiving the ultrasound.

HelioLiver offers a reliable and accessible approach to testing as a simple blood draw and has been validated in clinical studies with promising results.

Test Performance Characteristics

HelioLiver Dx test was 20% more sensitive and 6% less specific than ultrasound alone.

HelioLiver Dx had a higher sensitivity and specificity than the combination of ultrasound + AFP (10 ng/mL).

Image of sensitivity and specificity in the CLiMB Trial

HelioLiver Dx Test Meets Coprimary and Secondary Study Endpoints in the CLIMB Trial, presented at the EASL Congress 2024

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Cell-free DNA Methylation as an Alternative to Imaging

HelioLiver is a DNA-based test that examines a person’s specific genetic markup. When cells shed DNA into the bloodstream, that becomes “cell-free DNA”, or cfDNA. HelioLiver utilizes innovative new technology to isolate cfDNA from blood samples and analyzes for signs of cancer.

Most cfDNA comes from non-cancerous cells, but when it is released from cancerous cells, there are certain patterns that can be detected to suggest the presence of cancer in the body

These patterns come from a biological process called DNA methylation, which is an epigenetic mechanism used by cells to control gene expression. Research has shown that certain areas in DNA are methylated differently when cancer is present.

Helio has developed a groundbreaking algorithm to detect hepatocellular carcinoma within a blood sample. The algorithm can detect certain methylation patterns that signal cancer, while also searching for proteins that are known to be elevated with the presence of HCC.

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