Summary & Overview
CPT 0501U: QuantiDNA™ Colorectal Cancer Triage Test
CPT code 0501U designates the QuantiDNA™ Colorectal Cancer Triage Test, a proprietary laboratory analysis that quantitatively measures cell–free DNA (cfDNA) in blood to inform a patient’s colorectal cancer risk. As a PLA code, 0501U is specific to a single manufacturer's assay and is used to identify that unique laboratory service in claims and policy documents. Nationally, PLA codes like 0501U are important for tracking adoption of novel diagnostics, clarifying billing for proprietary assays, and informing coverage determinations for precision diagnostics.
Key payers reviewed include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find a concise explanation of the clinical purpose and service context for the test, summaries of payer coverage posture where available, and benchmarks relevant to utilization and coding practices. The publication also outlines common billing modifiers associated with laboratory services and notes where input data is not available. This overview is intended to help payers, providers, and policy analysts understand the coding and clinical role of CPT code 0501U in the national diagnostic landscape.
Billing Code Overview
CPT code 0501U is a Proprietary Laboratory Analyses (PLA) code that applies only to the QuantiDNA™ Colorectal Cancer Triage Test from DiaCarta Inc. The test uses quantitative measurement of cell–free DNA (cfDNA) in the blood to provide information about a patient’s risk for colorectal cancer.
Service type: Proprietary laboratory molecular diagnostic test
Typical site of service: Clinical laboratory or other certified laboratory facility (blood draw and laboratory processing)
Clinical & Coding Specifications
Clinical Context
A typical patient is a 55–75 year-old adult with a positive fecal immunochemical test (FIT), unexplained iron-deficiency anemia, a change in bowel habits, or a family history of colorectal cancer who is being evaluated noninvasively for colorectal cancer risk. The ordering clinician (primary care physician, gastroenterologist, or oncologist) orders the 0501U QuantiDNA™ Colorectal Cancer Triage Test to measure quantitative cell-free DNA (cfDNA) in a single peripheral blood sample. Blood is drawn in an outpatient laboratory, clinic, or ambulatory phlebotomy site; the specimen is shipped to DiaCarta Inc. or their designated reference lab for analysis. Results are returned to the ordering clinician and used as adjunctive information to guide decisions about need and timing of diagnostic colonoscopy, further imaging, or referral to gastroenterology. Typical clinical workflow: order placed in the electronic health record, specimen collection with standard venipuncture and appropriate tube, specimen labeling and shipment per lab instructions, laboratory analytic processing and reporting, and clinician review of results with patient to determine next steps in diagnostic evaluation or surveillance planning.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
00 | Default/No modifier | Use when no special reporting modifier is applicable to the service |
22 | Increased procedural services | Use when the test requires substantially greater work or resources than typical and documentation supports increased complexity |
52 | Reduced services | Use when the test was partially reduced or not fully performed and documentation supports reduced service |
53 | Discontinued procedure | Use when specimen collection or testing was started but stopped due to patient condition or other documented reasons |
| Taxonomy Code | Specialty | Notes |
|---|---|---|
208000000X | Pathology and Laboratory Medicine | Labs and pathologists coordinate testing protocols and result validation |
208000000S | Clinical Laboratory | Clinical laboratory directors and technical staff oversee analytic performance |
207Q00000X | Gastroenterology | Gastroenterologists order the test to triage need for colonoscopy |
207R00000X | Family Medicine | Primary care clinicians order the test as part of risk assessment and screening follow-up |
Related Diagnoses
| ICD-10 Code | Description | Clinical Relevance |
|---|---|---|
R19.5 | Hematochezia | Rectal bleeding can prompt noninvasive triage for colorectal cancer risk using cfDNA testing |
D50.9 | Iron deficiency anemia, unspecified | Unexplained iron-deficiency anemia in adults can be an indication to evaluate for occult colorectal malignancy |
K52.9 | Noninfective gastroenteritis and colitis, unspecified | Change in bowel habits or colitis symptoms may trigger adjunctive noninvasive testing |
Z82.49 | Family history of malignant neoplasm of other digestive organs and retroperitoneum | Positive family history increases pretest probability and may prompt use of triage testing |
Z12.11 | Encounter for screening for malignant neoplasm of colon | Used when noninvasive adjunct tests are performed in the context of colorectal cancer screening follow-up |
Related CPT Codes
| CPT Code | Description | Relationship to This Procedure |
|---|---|---|
0501U | QuantiDNA™ Colorectal Cancer Triage Test — quantitative cfDNA assay (Proprietary Laboratory Analyses) | Primary PLA code for the specific cfDNA blood test reported by DiaCarta Inc.; used to document and bill this unique laboratory service |
36415 | Collection of venous blood by venipuncture | Performed at the time of specimen collection for sending blood to the reference laboratory |
99000 | Handling and/or conveyance of specimen for transfer from the physician's office to a laboratory | Use when the office bills for specimen transport services according to payer policy |
G0008 | Administration of fecal occult blood test (FOBT) by physician or other qualified health care professional | May appear in the workflow when stool-based screening tests were performed previously and results trigger triage testing |
88360 | Immunohistochemistry (IHC) (if reflex tissue testing performed) | Related when cfDNA findings prompt tissue-based confirmatory testing or molecular pathology consultation |