Safety Information
HelioLiver™ Safety Information
The HelioLiver™ Test is intended for surveillance of hepatocellular carcinoma in men and women age 21 and over who are designated to be at high-risk for hepatocellular carcinoma due to a diagnosis of liver cirrhosis. The HelioLiver test is not intended as a replacement for diagnostic biopsies or diagnostic imaging by contrast enhanced MRI or CT.
HelioLiver results should be interpreted by a healthcare provider in the context of each individual patient's medical history. An indication of a “Normal” test result indicates a lower likelihood of hepatocellular carcinoma. Patients with a “Normal” test result but are still at risk for HCC should discuss with their healthcare provider about the recommended guidelines of surveillance every 3-6 months. An indication of an “Abnormal” test result may indicate the presence of hepatocellular carcinoma and indicates a need for follow-up diagnostic imaging.
The test results and interpretation are based on the proper identification of the submitted specimen(s) and accuracy of any stated clinical history. Abnormal results do not imply that there are no other contributors, genetic, or otherwise to this individual's condition, and normal results do not rule out a diagnosis for the indication for testing. This test is designed and validated for the detection of methylation profiles of select genomics regions and for the analysis of the protein tumor markers AFP, AFP-L3% and DCP listed on the report. The HelioLiver Test is not intended to subclassify or modify the classification of tumors that can be diagnosed by current clinical and pathological practice, nor to predict disease course or survival or treatment efficacy, nor to distinguish primary from metastatic tumors. This test cannot rule out the possibility of cancers, other than hepatocellular carcinoma.
Laboratory & Test Information
This test was developed, and its performance characteristics determined by Fulgent Genetics/Helio Health. This test has not been cleared or approved by the US Food and Drug Administration (FDA). The FDA does not require this test to go through premarket FDA review. This test is used for clinical purposes. It should not be regarded as investigational or for research. Fulgent Genetics is certified under the Clinical Laboratory Improvement Amendments (CLIA) as qualified to perform high complexity clinical laboratory testing. View Fulgent Genetics' accreditation documents here.