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.
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.
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Service type: Laboratory molecular diagnostic test using whole–genome sequencing with 5hmC enrichment
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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. |