Clinical Context
A typical patient is an adult with advanced or recurrent solid tumor (for example, non–small cell lung cancer, colorectal cancer, or breast cancer) who is being evaluated for targeted therapy or clinical trial eligibility. The oncologist orders a plasma-based circulating tumor DNA (ctDNA) genomic profile when tissue biopsy is unavailable, insufficient, or when a rapid, minimally invasive assessment of tumor genomic alterations is preferred. Blood is drawn in an outpatient infusion center, oncology clinic, or hospital phlebotomy service and sent to the performing laboratory (Personal Genome Diagnostics Inc.) for PGDx elio™ plasma focus Dx testing. The lab performs targeted sequencing of circulating cell–free DNA (cfDNA) across 33 genes, analyzes for actionable single-nucleotide variants, insertions/deletions, copy-number alterations, and selected fusions, and returns a report indicating detected actionable variants that could influence systemic therapy selection or trial matching. Results are reviewed at a follow-up oncology visit or tumor board to inform treatment decisions or to confirm need for additional tissue testing.
Related CPT Codes
| CPT Code | Description | Relationship to This Procedure |
|---|
81479 | Unlisted molecular pathology procedure | Used when elements of molecular testing performed are not covered by a specific CPT and for billing additional nonproprietary supplemental services related to genomic analysis. |
| 80500 | Drug assay, qualitative/quantitative, single drug | Performed when concurrent pharmacogenomic or drug monitoring assays are ordered alongside cfDNA profiling (not specific to PLA but may accompany oncology workup).
| 88184 | Flow cytometry, cell marker identification (per component) | May be performed in parallel in hematologic malignancy evaluation when liquid biopsies are part of a broader hematopathology assessment.
| 36415 | Collection of venous blood by venipuncture | The routine specimen collection CPT for obtaining the plasma sample sent to the laboratory prior to performing the PLA test.
| 88342 | Immunohistochemistry, each additional single antibody stain | Performed on tissue when tissue-based confirmatory testing or complementary biomarker analysis is required after cfDNA results.