Clinical Context
A 62-year-old male with a history of chronic hepatitis C and cirrhosis is undergoing routine hepatocellular carcinoma (HCC) surveillance. The clinician orders a proprietary blood-based methylation assay, TruD MDS Hepatocellular Carcinoma (0620U) from TruDiagnostic™ Inc. A whole blood sample is collected in clinic and sent to the manufacturer’s lab. The laboratory performs DNA methylation analysis at >5,000 CpG sites and applies the test-specific algorithm to report a binary risk result (positive or negative). Results are returned to the ordering provider who incorporates the assay result with imaging (ultrasound, MRI), alpha-fetoprotein levels, and clinical assessment to guide next steps such as diagnostic imaging, specialist referral to hepatology or oncology, or closer surveillance intervals.
Related CPT Codes
| CPT Code | Description | Relationship to This Procedure |
|---|
0620U | TruD MDS Hepatocellular Carcinoma (TruDiagnostic™ Inc.) — proprietary DNA methylation assay on whole blood reporting positive/negative risk | Primary PLA code for the proprietary molecular blood test used in HCC risk assessment and surveillance. |
81162 | Molecular pathology procedure, Level 2 (eg, targeted genomic sequence analysis panels) | May be performed for additional tumor-specific genomic testing if the PLA result prompts further molecular characterization.
81479 | Unlisted molecular pathology procedure | Used for reporting other novel or unlisted molecular tests not represented by a specific CPT when additional nonstandard assays are ordered.
80053 | Comprehensive metabolic panel (CMP) | Common concurrent laboratory test to assess liver function and overall metabolic status during HCC surveillance.
86332 | Alpha-fetoprotein (AFP) quantitative | Common serum tumor marker test performed alongside molecular assays for HCC surveillance and monitoring.
76700 | Ultrasound, abdominal, real time with image documentation; limited | Imaging frequently performed before or after molecular test results to evaluate for focal liver lesions when risk is positive.