Summary & Overview
CPT 0340U: Signatera™ ctDNA Minimal Residual Disease Test
CPT code 0340U designates Signatera™, a proprietary, personalized circulating tumor DNA (ctDNA) assay from Natera Inc. The test uses a cancer patient’s plasma specimen and a customized panel derived from prior tumor and germline next-generation sequencing to detect minimal residual disease (MRD). As a PLA code, 0340U is unique to a single manufacturer's assay and supports precision oncology workflows by enabling individualized monitoring for residual or recurrent disease.
This national overview addresses payer coverage patterns for major carriers, including Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find concise benchmarks on payer recognition of PLA tests, summaries of clinical context for MRD testing, and the policy and coding implications specific to a proprietary ctDNA assay. The publication outlines where payers have created coverage frameworks, highlights typical sites of service (clinical and hospital outpatient laboratories), and explains how CPT PLA coding signals a manufacturer-specific test versus broadly available assays.
The report provides practical information for billing and revenue cycle teams, laboratory administrators, and policy analysts: how 0340U is described in clinical terms, which payers are included in the review, and what topics are essential for contract and coding discussions. Data not available in the input are identified as such rather than inferred.
Billing Code Overview
CPT code 0340U is a Proprietary Laboratory Analyses (PLA) code that applies exclusively to Signatera™ from Natera Inc. The test analyzes a cancer patient’s plasma specimen using targeted sequencing of circulating tumor DNA (ctDNA) to evaluate minimal residual disease (MRD). The targeted sequences are customized based on a prior next-generation sequencing (NGS) analysis of the patient’s tumor and germline DNA, enabling a personalized assessment of tumor-derived DNA fragments in plasma.
Service type: Laboratory — proprietary, personalized ctDNA MRD testing
Typical site of service: Clinical laboratory or hospital outpatient laboratory using a patient plasma specimen
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Clinical & Coding Specifications
Clinical Context
A 58-year-old patient with stage II colon adenocarcinoma underwent surgical resection followed by adjuvant chemotherapy. After completion of therapy, the oncology team orders a personalized minimal residual disease (MRD) assay to monitor for molecular relapse. The test, Signatera™ (0340U), requires a baseline tumor tissue next-generation sequencing (NGS) profile and matched germline DNA to design a patient-specific ctDNA panel. A peripheral blood draw (plasma) is collected in a clinic or outpatient laboratory 2–6 weeks after surgery and then serially at defined surveillance intervals (for example every 3 months for the first 2 years). The clinical workflow includes: pre-test verification of prior tumor NGS and germline results, blood collection using cell-free DNA tubes, specimen shipping to Natera Inc., laboratory processing for targeted sequencing of personalized ctDNA markers, and reporting of qualitative and quantitative MRD results to the treating oncologist for surveillance and potential management decisions.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
00 | No modifier required / placeholder in some systems | Rarely used; included by some payors as default when no other modifier applies |
22 |