Liver Cancer Fusion Predictor

Everything you need to know about our Fusion-detect™ blood-based liver cancer screening test.

What We Test For

Detecting HCC Before Symptoms Appear

The Liver Cancer Fusion Predictor is designed to detect hepatocellular carcinoma (HCC), the most common form of primary liver cancer, accounting for approximately 75–85% of primary liver cancers.

The test detects cancer-associated fusion transcripts in serum. Fusion-detect™ technology integrates signals from multiple cancer-associated fusion transcripts using a proprietary predictive model to assess the presence of HCC from a blood sample.

Who may benefit from testing? Individuals at increased risk for HCC may consider testing in consultation with a healthcare provider. Risk factors include chronic hepatitis B or C, cirrhosis, metabolic dysfunction-associated steatotic liver disease (MASLD/MASH), heavy alcohol use, family history of liver cancer, and other conditions associated with chronic liver disease.

Performance Data

Clinical Validation Results

Clinical Validation Metric	Liver Cancer Fusion Predictor
Overall Accuracy	95.0%
Sensitivity	94.2%
Specificity	95.0%
Sample Type	Serum
Biomarker	Cancer-associated fusion transcripts
Analysis	Fusion-detect™ technology with proprietary predictive model

Liver Cancer Fusion Predictor vs AFP

Comparison Metric	Liver Cancer Fusion Predictor	AFP
Sensitivity	94.2%	~60%
Specificity	95.0%	~84%
Sample Type	Serum	Serum
Biomarker Approach	Multiple cancer-associated fusion transcripts	Single protein biomarker
Underlying Biology	Cancer-associated fusion transcripts arising from gene fusion events	Normally expressed protein that may become elevated in HCC and other liver conditions
Predictive Model	Yes	No

Comparison note: AFP performance varies by cutoff, patient population, and disease stage. The AFP estimates shown (~60% sensitivity and ~84% specificity) are based on published data using an AFP cutoff of approximately 20 ng/mL and are not from a direct head-to-head study with the Liver Cancer Fusion Predictor. Reference: Colli A, et al. Cochrane Database Syst Rev. 2021;4(4):CD013346. DOI:10.1002/14651858.CD013346.pub2. PMID: 33855699.

Clinical note: The Liver Cancer Fusion Predictor is a screening tool, not a diagnosis. A positive result should be followed up with a healthcare provider to confirm findings through appropriate clinical evaluation and imaging.

Pricing

Transparent, Affordable Pricing

No hidden fees. No surprise bills. The $160 introductory price includes the Liver Cancer Fusion Predictor and an at-home phlebotomy visit.

INTRODUCTORY OFFER

Home Visit

$160 / test

Liver Cancer Fusion Predictor with convenient at-home blood collection and a secure digital report.

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What does the Liver Cancer Fusion Predictor do?

The Liver Cancer Fusion Predictor is a blood-based screening test designed to assess the presence of hepatocellular carcinoma (HCC), the most common form of primary liver cancer. The test detects multiple cancer-associated fusion transcripts in serum and uses Fusion-detect™ technology with a proprietary predictive model to integrate these signals and assess the presence of HCC.

What type of liver cancer does the test assess?

The Liver Cancer Fusion Predictor is designed to assess hepatocellular carcinoma (HCC), the most common form of primary liver cancer. It is not currently intended to screen for other types of cancer.

How does at-home blood collection work?

After you order the test, MoleculeDx ships a blood collection kit to your home. A trained phlebotomist comes to your home to draw the blood using the collection materials provided in the kit. The phlebotomist then ships the collected sample to the MoleculeDx laboratory for analysis.

What sample is required for the test?

The Liver Cancer Fusion Predictor requires a blood sample. Serum is prepared from the blood sample and used to detect cancer-associated fusion transcripts. For the at-home option, a trained phlebotomist performs the blood draw.

Is the sample collection painful?

The test requires a standard blood draw. Most people experience only brief, mild discomfort similar to a routine blood test. For at-home collection, the blood draw is performed by a trained phlebotomist.

How accurate is the Liver Cancer Fusion Predictor?

In our clinical validation study, the Liver Cancer Fusion Predictor demonstrated 95.0% overall accuracy, 94.2% sensitivity, and 95.0% specificity for HCC. Test performance may vary in different patient populations, and no screening test detects every cancer.

Can the Liver Cancer Fusion Predictor be used for screening and monitoring?

The Liver Cancer Fusion Predictor is designed for HCC screening and may also be used to monitor cancer-associated fusion transcript signals after treatment. Following surgical resection or other treatment, serial testing may help determine whether previously detected fusion transcript signals persist or reappear. This information may assist the treating physician in evaluating possible residual or recurrent disease and determining whether additional clinical evaluation or imaging is appropriate. The test is not a substitute for diagnostic imaging or other clinical evaluation.

Why can blood-based monitoring be useful after HCC surgery?

AFP is not elevated in all patients with HCC, which can limit its usefulness for post-treatment monitoring in some patients. Cancer-associated fusion transcripts provide a different type of tumor-associated blood signal. In patients whose HCC is associated with detectable fusion transcripts, serial testing after treatment may provide additional information about the persistence or reappearance of cancer-associated fusion transcript signals.

Can the test produce false positives or false negatives?

Yes. No screening test is 100% accurate, and the Liver Cancer Fusion Predictor can produce false-positive or false-negative results. In our clinical validation study, the test demonstrated 94.2% sensitivity and 95.0% specificity for HCC. A positive result does not by itself establish a diagnosis of HCC, and a negative result does not completely exclude HCC. Results should be interpreted together with clinical findings and, when appropriate, diagnostic imaging.

What does my report look like?

Your report clearly indicates whether the Liver Cancer Fusion Predictor result is positive or negative. It also provides a summary of the test findings and an interpretation of what the result means. The report is reviewed by a pathologist and provided as a secure digital report. If the result is positive, follow-up with a healthcare provider for appropriate clinical evaluation and imaging is recommended.

What should I do if my result is positive?

A positive Liver Cancer Fusion Predictor result should be discussed with your healthcare provider. Because the test is a screening test and not a definitive diagnosis, a positive result should be followed by appropriate clinical evaluation and diagnostic imaging, such as contrast-enhanced CT or MRI, to determine whether an HCC tumor is present and, if present, its location.

How often should the Liver Cancer Fusion Predictor be performed?

For HCC screening, the testing interval depends on an individual’s liver cancer risk and should be discussed with a healthcare provider. For patients who have been treated for HCC, the test may be performed serially to monitor for persistence or reappearance of cancer-associated fusion transcript signals. The frequency of post-treatment testing should be determined by the treating physician based on the patient’s clinical circumstances.

Who should consider the Liver Cancer Fusion Predictor?

he Liver Cancer Fusion Predictor is intended for adults who may be at increased risk for HCC, including individuals with cirrhosis, chronic hepatitis B or C, fatty liver disease, or other chronic liver conditions associated with increased liver cancer risk. It may also be used in patients previously treated for HCC when their healthcare provider considers blood-based monitoring appropriate.

How does the Liver Cancer Fusion Predictor compare with imaging or biopsy?

The Liver Cancer Fusion Predictor is a minimally invasive blood-based test that detects cancer-associated fusion transcript signals associated with HCC. It is designed to complement, not replace, diagnostic imaging or biopsy. If the test is positive, contrast-enhanced CT or MRI can help determine whether a tumor is present and identify its location. Biopsy may be used when clinically appropriate to establish or further characterize a diagnosis.