HelioLiver LDT now available to order through Quest Diagnostics
Physician reviewing diagnostic results with a patient in a clinical setting
For Healthcare Providers

Detect Liver Cancer Earlier for Your High-Risk Patients

HelioLiver LDT is a blood test that aids in the detection of hepatocellular carcinoma (HCC) in adults at high risk, from a simple blood draw during a routine visit. In the prospective CLiMB study of adults with cirrhosis, HelioLiver demonstrated higher sensitivity than abdominal ultrasound for HCC detection (47.8% vs. 28.3%), with non-inferior specificity.

The Surveillance Gap

HCC Surveillance Is Recommended — But It's Failing Patients

Guidelines recommend HCC surveillance every six months for high-risk patients, typically with ultrasound and AFP. Yet most eligible patients are never screened, and ultrasound alone has limited sensitivity for small, early-stage tumors. HelioLiver was designed to close both gaps: a blood draw improves adherence, and combining cell-free DNA methylation with protein markers improves sensitivity for small lesions.

<20% of at-risk patients receive recommended HCC surveillance
~45% early-stage sensitivity of ultrasound alone (Tzartzeva 2018)
0% of lesions 2 cm or smaller detected by ultrasound in the CLiMB trial

Physicians see promise in a new way to look for HCC earlier.

Respondents reviewed a concise HelioLiver product proposition, rather than a full presentation of the clinical evidence, study endpoints, and detailed performance data, making the strength of this initial response especially encouraging.

Strong interest extends to intended use.

42%very
interested
38%extremely
interested
70%

said they would definitely or probably order HelioLiver for an appropriate patient within the next six months.

69%

envision using HelioLiver in addition to ultrasound, either broadly among appropriate patients or in selected situations.

Earlier detection and blood-based testing drive appeal.

Selected the potential for earlier HCC detection as a compelling aspect of HelioLiver.

Selected blood-based testing as a compelling aspect.

Physicians also see practical potential.

Said HelioLiver would be easy to incorporate into their current practice.

Believed patients would be more likely to complete blood-based surveillance than imaging-based surveillance.

Source: Helio Genomics quantitative HCP survey conducted through SERMO, August 17–21, 2026; n=100 U.S. physicians, including 50 hepatologists and 50 gastroenterologists. Respondents reviewed a concise HelioLiver product proposition before answering questions about interest, intended use, and practice fit.

How HelioLiver Works

How the HelioLiver Test Works

HelioLiver is a simple blood test that reads cell-free DNA (cfDNA) methylation patterns alongside serum protein tumor markers and clinical information, using machine learning to assess the likelihood of HCC. By reading the molecular signals of cancer in the blood, it can detect HCC, including the small, early-stage lesions that are hardest to catch.

A clinician holding the HelioLiver LDT Collection Kit box
HelioLiver Collection Kit 1simple blood draw
Watch & Learn

See How HelioLiver Overcomes Surveillance Obstacles

Learn how HelioLiver's methylation approach overcomes today's surveillance obstacles. Presenter: Shivani Mahajan, Head of Computational Science · 5:19
Supported by Robust Clinical Data

Validated in the CLiMB Trial, Published in the Journal of Hepatology

CLiMB is the largest completed prospective, multicenter liquid-biopsy liver cancer trial in the United States, using contemporaneous MRI as the reference standard. HelioLiver met its co-primary endpoints — superior sensitivity and non-inferior specificity — compared with ultrasound.

1,268
evaluable participants across 42 US clinical sites
47.8% vs 28.3%
Overall HCC sensitivity, HelioLiver vs ultrasound
40.0% vs 10.0%
early-stage (T1) HCC, a 4-fold difference
Published in the Journal of Hepatology Prospective · Multicenter MRI Reference Standard
Now available to order through Quest Diagnostics, one of the largest diagnostic networks in the United States, with a strategic commercial partnership with Syneos Health accelerating nationwide adoption. CLiMB was led by Principal Investigator Professor Mindie Nguyen, MD, of Stanford University, with investigators at clinical sites across the US.
Ordering Is Easy

Ordering HelioLiver for Your Patients Is Easy

1

Order the Test

Order through your office's process via TRF or EMR, or order through Quest Diagnostics. Our team sets up your office with kits and training.

2

Patient Sample Collection

A simple blood draw during a routine visit. The Collection Kit includes everything needed, with a prepaid return label.

3

Receive Results

Results are available in 10–14 days. You receive a clear Normal or Abnormal report indicating the likelihood of HCC, with confirmatory imaging (MRI or CT) recommended for abnormal results. A normal result does not exclude HCC and does not replace ongoing surveillance.

Which Patients to Test

Which of Your Patients May Benefit

HelioLiver LDT is intended for patients at high risk of HCC who are recommended for routine surveillance, including:

Cirrhosis

Cirrhosis of any etiology

Hepatitis B & C

Chronic hepatitis B or hepatitis C

MASLD / NAFLD & alcohol-related

Alcohol-related or metabolic liver disease

Advanced fibrosis & other

Advanced fibrosis, hereditary hemochromatosis, primary biliary cholangitis, Wilson's disease

AASLD recommendation: AASLD recommends HCC surveillance approximately every six months for patients at high risk, such as those with cirrhosis.

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Bring Earlier Liver Cancer Detection to Your Practice

Join the providers using HelioLiver to detect HCC earlier — from a simple blood draw.

The HelioLiver test is a laboratory developed test intended to aid in the detection of hepatocellular carcinoma in adults at high risk. It is not a replacement for guideline-recommended surveillance imaging and it is not a diagnostic test. A positive result requires diagnostic follow-up. A negative result does not exclude the presence of hepatocellular carcinoma.