Liver Cancer Surveillance Starts with a Signal
A blood test designed to identify an HCC-associated molecular signal—including in patients with small tumors—so you and your clinician can investigate a positive result.
A signal worth investigating
Looking for evidence of HCC in a blood sample
The MoleculeDx Liver Cancer Fusion Predictor is a blood-based HCC surveillance test designed to look for cancer-associated cell-free fusion-transcript signals. The goal is to identify a molecular warning signal that may indicate the presence of liver cancer—even when HCC is still small or has caused no symptoms.
It is a surveillance indicator, not a stand-alone diagnostic test. A positive result is a reason to investigate for HCC promptly. A negative result is reassuring and suggests that HCC is less likely, but continued surveillance remains important for people at high risk.
Our development objective: To replace the traditional ultrasound-plus-AFP surveillance strategy with the Liver Cancer Fusion Predictor, used by itself or combined with ultrasound. This proposed replacement approach has not yet been authorized by FDA.
Your report, explained
What will my test result tell me?
Your MoleculeDx surveillance report provides a Positive or Negative result for the liver-cancer-associated molecular signal assessed by the test. It is intended to help you and your clinician decide what follow-up is appropriate.
Cancer-associated signal detected
The blood test detected a molecular pattern associated with HCC. HCC may be present and should be investigated promptly with your treating clinician. A positive result does not establish the diagnosis, because false-positive signals are possible. Your clinician may recommend appropriate liver imaging and further assessment.
HCC-associated signal not detected — HCC is less likely
This is a reassuring result. The test did not detect the HCC-associated molecular pattern in your blood sample, suggesting that liver cancer is less likely at the time of testing. However, like other surveillance tests, it can occasionally miss an existing cancer.
If you are at high risk for HCC, continue periodic surveillance with your healthcare provider. Repeat Liver Cancer Fusion Predictor testing can be discussed as part of a clinician-directed monitoring plan. MoleculeDx is pursuing an FDA pathway for its proposed use as an alternative to ultrasound plus AFP, either alone or paired with ultrasound. Until that proposed replacement use is authorized and incorporated into your care plan, follow your clinician's current surveillance recommendations. Contact your clinician if symptoms arise or other test results are concerning.
A surveillance result is an indicator that helps guide clinical evaluation. Whether a positive result represents HCC depends on the individual clinical situation and requires medical assessment.
Why earlier signals matter
Why focus on small liver tumors?
HCC often develops without warning symptoms. Identifying a concerning signal when a tumor is still small may create opportunities for earlier diagnostic assessment and, in suitable patients, potentially curative treatments. This is why MoleculeDx is investigating molecular surveillance for early-stage HCC.
In a small research subgroup with confirmed HCC, the fusion-based model (which included AFP) was positive in all nine cases; AFP alone at the study's 200 ng/mL cutoff was positive in three of nine.
In a research subgroup meeting Milan criteria, the fusion-based model was positive in 21 of 22 confirmed HCC cases; AFP alone was positive in 8 of 21 evaluable cases.
These are research findings in patients already known to have HCC. They do not establish how often the test will be positive in cancer-free patients or the chance that a positive result means HCC during routine surveillance. The study groups were small, and the fusion-based model included AFP. See all four subgroups, 95% confidence intervals, and limitations.
Who should consider HCC surveillance?
HCC surveillance is most relevant for people at increased risk, including many patients with cirrhosis and selected patients with chronic hepatitis B. Some individuals with chronic hepatitis C or metabolic liver disease are eligible depending on cirrhosis and other risk factors. Discuss your personal risk and the role of additional blood-based testing with a qualified clinician.
The intended replacement strategy—and current guidance
MoleculeDx's FDA development goal is to replace the conventional ultrasound-plus-AFP surveillance strategy with the Liver Cancer Fusion Predictor alone or together with ultrasound. This proposed replacement use is part of the company's FDA Breakthrough Device designation request; it has not been authorized by FDA as a replacement strategy.
Current AASLD guidance recommends ultrasound plus AFP about every six months for eligible at-risk patients. Discuss your surveillance regimen and any repeat molecular testing with your clinician. A positive molecular result should prompt appropriate diagnostic assessment, including imaging when indicated. Read HCC surveillance guidance.
How does testing work?
Order the blood test
Start through MoleculeDx's secure booking portal, review the current $160 standard package, and provide the necessary booking details.
Provide a blood sample
Arrange mobile phlebotomy where available. The specimen is transported for laboratory analysis of HCC-associated signals.
Review your report
Receive a positive or negative surveillance result and review its significance and next steps with a healthcare professional.
Collection availability and reporting time depend on location, transport, laboratory processing, and clinical review; check your booking information for current arrangements.
Take the next step in liver cancer surveillance
The Liver Cancer Fusion Predictor is intended to help flag molecular signs associated with HCC—particularly important when a cancer is small and not yet causing symptoms. Discuss the appropriate surveillance and follow-up plan with your clinician.