Summary & Overview

CPT 0507U: Avantect Ovarian Cancer Test—WGS with 5hmC Enrichment

Headline: CPT code 0507U: New PLA code for the Avantect Ovarian Cancer Test using WGS with 5hmC enrichment

Lead: CPT code 0507U designates a Proprietary Laboratory Analyses (PLA) test — the Avantect Ovarian Cancer Test from ClearNote® Health — which applies whole–genome sequencing (WGS) with 5–hydroxymethylcytosine (5hmC) enrichment on blood or plasma to detect ovarian cancer and issues a binary detected/not-detected result. The code matters nationally as it identifies a specific laboratory-developed molecular diagnostic with distinct clinical and billing handling.

Why it matters: PLA codes like 0507U are tied to a single manufacturer's test and are used for laboratory claim submission, price transparency, and payer coverage determination. As a high-complexity genomic assay that targets early detection or diagnostic confirmation of ovarian cancer, this test has implications for clinical pathways, utilization management, and reimbursement policy across payers.

Key payers covered: Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare.

What readers will learn: This publication explains the clinical purpose and billing identity of CPT code 0507U, outlines typical sites of service and the test methodology, and summarizes the payer landscape considered in this analysis. It also identifies available benchmarks, policy considerations, and clinical context relevant to payers and providers. Data not available in the input will be noted where applicable.

AetnaBlue Cross Blue ShieldCigna HealthUnitedHealthcareMedicare0507UCPTProprietary Laboratory Analysesmolecular diagnosticswhole-genome sequencing5hmCovarian cancerlaboratory testgenomic assay

Billing Code Overview

CPT code 0507U is a Proprietary Laboratory Analyses (PLA) code reported only for the Avantect Ovarian Cancer Test from ClearNote® Health. The test uses whole–genome sequencing (WGS) with 5–hydroxymethylcytosine (5hmC) enrichment on blood or plasma samples to detect ovarian cancer and returns a report indicating whether cancer is detected or not.

Service type: Laboratory molecular diagnostic test using whole–genome sequencing with 5hmC enrichment
Typical site of service: Clinical laboratory or reference laboratory processing blood or plasma specimens

Clinical & Coding Specifications

Clinical Context

A 58-year-old woman with a pelvic mass on ultrasound and elevated CA-125 levels presents for further noninvasive diagnostic evaluation. Her gynecologic oncologist orders the Avantect Ovarian Cancer Test (ClearNote® Health) to assess for circulating tumor signal from a peripheral blood or plasma sample. The clinical workflow: the clinician documents the indication and obtains informed consent for a blood draw; phlebotomy collects the specimen into the manufacturer-specified tube; the specimen is shipped to the performing laboratory with required chain-of-custody and stabilization instructions. The laboratory performs whole–genome sequencing (WGS) with 5–hydroxymethylcytosine (5hmC) enrichment and runs the proprietary analytic pipeline. The lab issues a report indicating whether ovarian cancer was detected or not, which the ordering provider reviews with the patient to inform next steps such as imaging, biopsy, referral to gynecologic oncology, or surveillance.

Coding Specifications

Modifier	Description	When to Use
`00`	Default—no modifier	Use when no special circumstances apply to the service.
`22`	Increased procedural services	Use when the laboratory documents substantially greater work or resources for processing or analysis beyond typical complexity.
`26`	Professional component	Use when reporting only the professional component (interpretation/report) provided separately from the technical lab processing.
`52`	Reduced services	Use when the test is partially reduced or not fully performed for clinical reasons.
`53`	Discontinued procedure	Use when specimen processing is begun but testing is discontinued for documented clinical or technical reasons.
`62`	Two surgeons/dual physician involvement	Rare for this lab test; use if two physicians share responsibility for reporting or interpretation per payer rules.
`78`	Unplanned return to OR	Not typically applicable to this lab test; included for completeness when surgical procedures are linked to testing.
`80`	Assistant surgeon	Not applicable to the lab assay itself; may apply to related surgical procedures.
`82`	Assistant not available	As above, relevant only for associated operative services.
`AS`	Physician assistant, nurse practitioner, or clinical nurse specialist services	Use when these professionals perform specimen collection or order/follow-up under their credentials per payer policy.
`QK`	Medical direction of two, three, or four assistants	Pertains to operative assistance, relevant only when linked services are billed.
`QX`	Modifier for CRNA service with certified anesthesiologist assistant	Not applicable to the assay but retained for associated perioperative claims.
`QY`	Medical direction of one qualified resident	As above, for related physician-directed services rather than the lab test itself.

Taxonomy Code	Specialty	Notes
208D00000X	Obstetrics & Gynecology	Ordering and follow-up by OB/GYN or gynecologic oncologist for suspected ovarian malignancy.
207L00000X	Hematology & Oncology	Medical oncologists involved in diagnosis, staging, and systemic treatment planning.
363A00000X	Clinical Laboratory	Laboratory directors and molecular pathologists who perform and interpret WGS/epigenomic assays.
207K00000X	Medical Oncology (Gynecologic)	Gynecologic oncology subspecialists who integrate results into surgical and treatment planning.

Related Diagnoses

ICD-10 Code	Description	Clinical Relevance
`C56.9`	Malignant neoplasm of ovary, unspecified	Primary diagnosis when ovarian cancer is confirmed or strongly suspected; directly relevant to the Avantect test.
`C57.3`	Malignant neoplasm of fallopian tube	Related gynecologic malignancy; epigenomic blood tests may detect signals from adnexal malignancies.
`C48.1`	Malignant neoplasm of pelvic peritoneum	Peritoneal carcinomatosis can be associated with ovarian primary disease; testing may aid noninvasive detection.
`D39.1`	Neoplasm of uncertain behavior of ovary	Used when imaging findings are indeterminate and noninvasive molecular testing is part of diagnostic evaluation.
`R19.0`	Intra-abdominal and pelvic swelling, mass and lump	Symptom code supporting the clinical rationale for ordering a blood-based ovarian cancer detection assay.

Related CPT Codes

CPT Code	Description	Relationship to This Procedure
`0507U`	Avantect Ovarian Cancer Test; whole–genome sequencing with 5–hydroxymethylcytosine enrichment (proprietary PLA)	Primary PLA code to report the Avantect test performed by ClearNote® Health.
`80053`	Comprehensive metabolic panel; includes multiple chemistry tests	Commonly ordered concurrently to evaluate baseline organ function prior to further diagnostic procedures or treatment.
`84153`	Prostate specific antigen (PSA) — example of tumor marker testing	Analogous tumor marker testing workflows; tumor markers like CA-125 (`82728`) are typically ordered alongside ovarian cancer evaluations.
`82728`	CA-125; cancer antigen 125 assay	Frequently ordered in the diagnostic workup and surveillance of ovarian cancer alongside molecular blood tests.
`88342`	Immunohistochemistry, per specimen; initial single antibody stain	Performed on tissue biopsy or surgical specimens when tissue diagnosis follows a positive circulating test.
`88172`	Cytopathology, interdepartmental consultation	May be used for cytologic review of fluid or biopsy specimens obtained after a positive blood-based test.