CPT 0307U: Invitae PCM MRD Monitoring, ctDNA Assay

CPT code 0307U designates Invitae PCM MRD Monitoring, a Proprietary Laboratory Analyses (PLA) molecular test that assesses circulating tumor DNA (ctDNA) in blood to detect minimal residual disease (MRD) and monitor for cancer recurrence following a tumor profile established by CPT code 0306U. As a PLA code, 0307U applies to a single manufacturer-specific assay, making it important for laboratories, oncology clinicians, and payers to recognize its unique clinical and billing status. Nationally, MRD monitoring with sensitive ctDNA assays is increasingly relevant for personalized oncology care and post-treatment surveillance.

Key payers covered in this review include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find a concise overview of the code’s clinical purpose, common sites of service, and where the test fits in care pathways. The publication also summarizes payer coverage patterns and benchmark considerations, highlights recent policy developments affecting molecular diagnostics and PLA codes, and provides clinical context for MRD monitoring with ctDNA. Data not available in the input will be identified and omitted; the focus remains on the code’s definition, clinical application, and implications for coding and payer interactions at a national level.

Billing Code Overview

CPT code 0307U is a Proprietary Laboratory Analyses (PLA) code that applies exclusively to a single, manufacturer-specific test: Invitae PCM MRD Monitoring from Invitae Corporation. The test analyzes a patient blood specimen for circulating tumor DNA (ctDNA) that corresponds to a tumor profile previously identified by CPT code 0306U. Clinicians use this test to detect the presence of minimal residual disease (MRD) after treatment and to monitor patients for cancer recurrence.

Service type: Laboratory — Proprietary molecular/ctDNA assay

Typical site of service: Clinical laboratory or outpatient phlebotomy collection site

Clinical Context

A 58-year-old patient with a previously characterized solid tumor (tumor profiling reported under 0306U) completed definitive therapy (surgery with adjuvant chemotherapy). The oncology team orders Invitae PCM MRD Monitoring (0307U) to evaluate circulating tumor DNA (ctDNA) from a peripheral blood specimen for minimal residual disease (MRD) and surveillance for early recurrence. The typical clinical workflow: the clinician places the order in the electronic health record specifying the prior tumor profile linkage to the original 0306U report, the phlebotomy team draws a specialized blood tube and ships it to Invitae per kit instructions, the laboratory performs tumor-informed ctDNA analysis and reports presence/absence and quantitative measures of ctDNA related to the previously identified tumor variants, and the ordering oncologist uses the result to inform surveillance intervals and consideration of additional imaging or systemic therapy changes. Typical site of service is an outpatient oncology clinic or outpatient phlebotomy/laboratory collection center; sample processing and testing occur at the proprietary laboratory facility performing the test.

Coding Specifications

Modifier	Description	When to Use
`00`	No modifier

Taxonomy Code	Specialty	Notes
`207RX0400X`	Hematology & Oncology	Medical oncologists ordering MRD surveillance and interpreting results
`207K00000X`	Surgical Oncology	Surgeons who performed tumor resection and coordinate post-op surveillance
`207L00000X`	Medical Genetics	Molecular pathologists or genomic medicine specialists involved in test interpretation and variant matching
`363L00000X`	Clinical Laboratory	Laboratory directors and molecular diagnostics laboratorians overseeing testing processes

Related Diagnoses

ICD-10 Code	Description	Clinical Relevance
`C79.9`	Secondary malignant neoplasm of unspecified site	Reflects metastatic disease surveillance where ctDNA MRD testing can detect residual or recurrent disease
`C80.1`	Malignant (primary) neoplasm, unspecified	Used when primary tumor site is unspecified but MRD monitoring is indicated
`C45.9`	Mesothelioma, unspecified	Tumor types where prior profiling and MRD strategies may be applied depending on available biomarkers
`C34.90`	Malignant neoplasm of unspecified part of right bronchus or lung	Lung cancers commonly monitored with ctDNA for recurrence and MRD
`D05.90`	Carcinoma in situ of breast, unspecified	Post-treatment surveillance scenarios for breast cancer where ctDNA may be used adjunctively

Related CPT Codes

CPT Code	Description	Relationship to This Procedure
`0306U`	Invitae PCM Tumor Profiling (proprietary tumor profiling assay)	Prior tumor profiling used to identify patient-specific variants that `0307U` monitors in plasma; often performed before MRD monitoring
`86316`	Antigen; tumor (antigen detection by immunoassay)	General tumor marker assays that may be ordered alongside ctDNA monitoring for broader surveillance
`88172`	Cytopathology, fluid, washings, or brushings; immediate interpretation	Rapid cytologic assessment that may precede or follow imaging prompted by MRD positivity
`84153`	Prostate specific antigen (PSA)	Example organ-specific tumor marker commonly used with MRD testing in prostate cancer surveillance
`81479`	Unlisted molecular pathology procedure	Used occasionally for reporting ancillary or custom molecular testing not covered by a PLA when additional non-proprietary analyses are performed

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Summary & Overview