HelioLiver LDT now available to order through Quest Diagnostics
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Laboratory scientist analysing a blood sample for HelioLiver LDT testing
Available now for clinical use

HelioLiver™ LDT

A multi-analyte, epigenomic blood test combining cell-free DNA (cfDNA) methylation patterns and protein tumour markers.

A Breakthrough in Liver Cancer Testing

A Breakthrough in Liver Cancer Testing

HelioLiver LDT is a new, non-invasive blood test that detects DNA markers associated with a higher risk of hepatocellular carcinoma (HCC). HelioLiver LDT can be done using a simple blood draw during a regular physician visit, eliminating the need for a separate appointment at an imaging lab.

Powered by advanced AI and machine learning, HelioLiver LDT is the first blood test to use methylation to detect early-stage liver cancer, offering new hope to patients and healthcare providers. Early detection opens up more curative treatment options, improving outcomes for all.

Blood Sample
cfDNA Methylation
Protein Biomarkers
Machine Learning
Early Detection
Clinical Decision
Now Validated in the Journal of Hepatology

Proven Superior to Ultrasound in the CLiMB Trial

In the pivotal CLiMB trial — a prospective, blinded, multicenter US study in 1,968 patients with cirrhosis — HelioLiver detected HCC at 76.1% sensitivity versus 44.4% for ultrasound, with non-inferior specificity. The results are now peer-reviewed and published in the Journal of Hepatology.

1,968
patients with cirrhosis enrolled in the prospective, blinded, multicenter US study
76.1%
HCC sensitivity with HelioLiver
44.4%
HCC sensitivity with ultrasound
Peer-Reviewed Publication Journal of Hepatology Non-Inferior Specificity
Elevating the Standard of Care

Elevating the Standard of Care

Guidelines recommend routine HCC surveillance for cirrhosis, typically with an ultrasound every six months. However, fewer than 20% of patients receive the recommended testing. Why?

<20%
Today, fewer than 20% of at-risk patients receive recommended testing for HCC.

Patient-Reported Barriers

Scheduling

Requires a separate visit, potentially at a different centre.

Socioeconomic reasons

A separate appointment may mean another day off work.

Long wait times

Delays in getting an imaging appointment.

Access to a nearby imaging lab

Imaging centres may be far from the patient.

Uncertainty

Uncertainty about where to get surveillance.

HelioLiver vs Ultrasound

Designed to Improve Both Patient Adherence and Sensitivity for Small Lesions

HelioLiver
Blood-based · multi-analyte
Recommended
Sensitivity for lesions <2cm29%
Sensitivity for Stage 1 HCC44%
Turnaround time10–14 days
Surveillance methodBlood draw (~5 min)
SchedulingSame day at the doctor's office
Analysis methodLiver serum levels + DNA methylation signals
Ultrasound
Imaging · standard of care
Sensitivity for lesions <2cm0%
Sensitivity for Stage 1 HCC11%
Turnaround time~20 days
Surveillance methodImaging (30–60 min)
SchedulingSeparate appointment at the imaging centre
Analysis methodVisual scan
Watch & Learn

Learn How HelioLiver's Methylation Approach Overcomes Today's Surveillance Obstacles

Learn How HelioLiver's Methylation Approach Overcomes Today's Surveillance Obstacles Presenter: Shivani Mahajan, Head of Computational Science at Helio Genomics 5:19
The HelioLiver LDT Workflow

Ordering the HelioLiver Test Is Simple and Straightforward

1

Order Test

Each provider is set up with an ordering process fit for their office (via TRF or EMR).

2

Collect Sample

The HelioLiver Collection Kit provides materials to collect and pack serum and plasma samples from each patient.

3

Ship It Back

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

4

Wait for Analysis

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

5

Receive Report

A 'Normal' or 'Abnormal' result is given to indicate the likelihood of HCC.

Driving Patient Adherence

Driving Patient Adherence

Routine surveillance is critical for patients to catch cancer early before it spreads. We partner with physicians to help ensure patients maintain the recommended schedule for liver cancer testing. Testing intervals for HCC surveillance consider tumour doubling time and the cost of the surveillance test. Guidelines recommend that patients at high risk for HCC, such as those with cirrhosis, undergo surveillance every six months.