HelioLiver LDT now available to order throughvia Quest Diagnostics

HelioLiver LDTDetect liver cancer earlier with a simple blood test

HelioLiver™ LDT is an epigenomic blood test for liver cancer surveillance in high-risk patients. It analyzes cell-free DNA methylation together with protein tumor markers to detect HCC at its earliest, most treatable stages. In the CLiMB trial, it detected 4× more Stage I cancers than ultrasound.1

44% vs 11% Stage I HCC detection · CLiMB Trial Validated in the CLiMB Trial Published in the Journal of Hepatology
Clinician collecting a blood sample from a patient in a bright, modern diagnostics laboratory
More effective than ultrasound at Stage I HCC detection
44% Stage I HCC detection vs. 11% ultrasound · CLiMB Trial
Journal of HepatologyPeer-reviewed, May 2026
Validated · CLiMB Trial

Clinical evidence

Innovative technology with higher sensitivity makes early detection possible

By combining the results of cell-free DNA methylation testing with data from protein tumor markers and other clinical information, HelioLiver LDT delivers superior performance characteristics when compared to traditional tests for hepatocellular carcinoma (HCC).

Higher sensitivity to detecting smaller cancerous tumors means catching liver cancer cases in early stages, when curative options are available.

HelioLiver vs. Ultrasound — CLiMB Trial Results1

  • T1 HCC detection44% vs. 11%
  • Tumours ≤ 2 cm29% vs. 0%

CLiMB trial: prospective, blinded, multicenter US evaluation in patients with cirrhosis.

Stage I HCC sensitivity — CLiMB Trial

HelioLiver LDT Ultrasound
Stage I (T1) HCC+33 pts
HelioLiver
44%
Ultrasound
11%
Tumours ≤ 2 cm+29 pts
HelioLiver
29%
Ultrasound
0%
Source: CLiMB Trial · Journal of Hepatology, 2026 Prospective · Blinded · Multicenter

Sensitivity by tumor size — CLiMB Trial

HelioLiver LDT Ultrasound
Tumor ≤ 2 cmPotential treatment: resection or transplant
HelioLiver
29%
Ultrasound
0%
> 2 cm to ≤ 3 cmPotential treatment: ablation
HelioLiver
54%
Ultrasound
31%
> 3 cmChemotherapy · poorer prognosis
HelioLiver
75%
Ultrasound
75%
Source: CLiMB Trial · Journal of Hepatology, 2026

What is HelioLiver

A breakthrough in liver cancer testing

HelioLiver is an epigenomic blood test that combines cell-free DNA methylation, protein tumor markers, and clinical context to support early HCC detection in high-risk patients.

HelioLiver LDT Collection Kit

cfDNA methylation

Reads cancer-related DNA changes circulating in the blood.

Protein tumor markers

Add a second layer of HCC signal alongside the methylation data.

Clinical context

Brings both together for a clear result in high-risk patients.

more effective than ultrasound at detecting Stage I HCC1

44% vs 11%

T1 HCC detection in the CLiMB trial1

29% vs 0%

sensitivity for tumours ≤ 2 cm1

Find your path

Find resources for your role

For Healthcare Providers

If you are a hepatologist, gastroenterologist, or oncologist, HelioLiver LDT can support liver cancer screening and HCC surveillance in high-risk patients. It is a blood test for liver cancer that uses a simple blood draw during a regular physician visit.

Key benefits
  • Supports liver cancer screening in appropriate high-risk patients.
  • Simple blood draw during a routine office visit.
  • Designed to fit into HCC surveillance workflows.
For Patients

If you have cirrhosis or another liver cancer risk factor, ask your doctor about HelioLiver LDT for early HCC detection. Liver cancer screening is especially important for people at higher risk, including those with cirrhosis and chronic hepatitis-related liver disease.

Know your risk factors
  • Cirrhosis from hepatitis B or C, alcohol use, or NAFLD.
  • Chronic hepatitis B infection.
  • Advanced liver fibrosis.
For Investors

Helio Genomics is focused on early cancer detection through a clinically grounded blood test platform for liver cancer. The company’s CLiMB study publication and broader market coverage support its positioning in liver cancer diagnostics.

Key highlights
  • The CLiMB study was published in the Journal of Hepatology.
  • Strategic commercial expansion through Quest access.
  • Public coverage highlighting the need for earlier detection.
  • Multi-analyte blood-based approach for HCC detection.

Why it matters

Timing matters: early detection saves lives

Liver cancer is often diagnosed after it has already advanced. Finding it earlier can expand treatment options and improve outcomes.

Early-Stage (Localized) HCC
37%
5-Year Relative Survival Rate2

Curative options may include resection, transplant, or localized therapy.

Advanced-Stage (Distant) HCC
3%
5-Year Relative Survival Rate2

Treatment often focuses on systemic therapy and symptom management.

If you have cirrhosis, chronic hepatitis B or C, heavy alcohol use, or NAFLD, you may be at higher risk for HCC. AASLD recommends HCC surveillance about every 6 months for people with cirrhosis.3

Check If You're at High Risk

Simple process

How to order HelioLiver

1

Order Test

Each provider is set up with an ordering process that fits their office workflow, either through TRF or EMR.

2

Collect Sample

The HelioLiver Collection Kit includes the materials needed to collect and prepare serum and plasma samples from each patient.

3

Ship It Back

A prepaid return shipping label is included in each test kit for easy shipping.

4

Wait for Analysis

Average turnaround time is 10–14 days for each sample.

5

Receive Report

You’ll receive a Normal or Abnormal result to indicate the likelihood of HCC.

Partnerships

Trusted partners

cfDNA methylation — methyl markers binding along a DNA helix

The technology

The science behind HelioLiver

HelioLiver LDT combines cfDNA methylation, protein biomarkers, and clinical data to support early HCC detection in high-risk patients.

Why it matters

Cancer cells can create detectable methylation changes in blood.

Clinical validation

  • CLiMB trial in high-risk cirrhotic patients.
  • Head-to-head comparison with ultrasound.
  • MRI is used to confirm HCC status in clinical evaluation.

Newsroom

Latest news & updates

Medical journal on a desk — CLiMB Study publication
Publication · May 2026

CLiMB Study Published in Journal of Hepatology

The largest prospective, multicenter U.S. trial of its kind demonstrates superior sensitivity for early HCC detection.

Read the Publication
Two healthcare professionals reviewing a partnership plan
Partnership April 2026

Helio Genomics partners with Syneos Health to accelerate liver cancer detection

Read Press Release
Scientist examining a blood sample in a molecular biology laboratory
Research March 2026

Landmark CLiMB Study Demonstrates Superior Sensitivity of HelioLiver™, a Multi-Analyte Blood Test, Over Ultrasound for Early Detection of Hepatocellular Carcinoma

Read Press Release

Watch

See the science in action

Questions

Frequently asked questions about HelioLiver

HelioLiver LDT is a multi-analyte, epigenomic blood test for liver cancer surveillance and early hepatocellular carcinoma (HCC) detection. It combines cell-free DNA methylation patterns, protein tumor markers, and clinical information to detect liver cancer with superior sensitivity compared to ultrasound.
Patients at high risk for HCC, particularly those with:
  • Liver cirrhosis (from Hepatitis B/C, alcohol, NAFLD)
  • Chronic Hepatitis B infection
  • Advanced liver fibrosis
AASLD guidelines recommend surveillance every 6 months for these patients.
In the CLiMB trial, HelioLiver detected Stage I HCC at 44% vs. 11% for ultrasound. For tumours ≤ 2 cm, HelioLiver achieved 29% sensitivity while ultrasound detected 0%.
HelioLiver LDT is a laboratory-developed test (LDT) regulated under CLIA 1988. It has not been cleared or approved by the FDA, but is available for clinical ordering.
Contact our team at +1 (949) 229-2490 or info@heliogenomics.com. We'll set up your office with kits and training. Ordering is available via TRF or EMR integration.
Average turnaround time is 10–14 days. You'll receive a one-page report indicating "Normal" (low likelihood of HCC) or "Abnormal" (may indicate HCC detected).
Normal: Low likelihood of HCC — continue surveillance every 3–6 months per physician guidance.

Abnormal: May indicate HCC was detected — follow physician guidelines for additional diagnostic imaging (MRI, CT).
Every 6 months for patients with cirrhosis, per AASLD guidelines.
Coverage and billing details are being finalised. Please contact our team at +1 (949) 229-2490 or info@heliogenomics.com for the latest information on cost and insurance coverage.

Get started

Start detecting liver cancer earlier today

4× more effective than ultrasound for Stage I HCC detection.1 The CLiMB study was published in the Journal of Hepatology.

Order HelioLiver