Summary & Overview
CPT 0306U: Invitae PCM Tissue Profiling and MRD Baseline Assay
CPT code 0306U designates the Invitae PCM Tissue Profiling and MRD Baseline Assay, a Proprietary Laboratory Analyses (PLA) test that sequences tumor DNA to create a baseline profile for later minimal residual disease (MRD) monitoring. As a PLA code, 0306U applies exclusively to a single manufacturer’s assay and is important for payers and providers because it identifies a specific, proprietary molecular diagnostic service used in cancer care and longitudinal MRD surveillance.
Key payers discussed include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find a concise clinical and billing context for the assay, how the code is used to capture the baseline tumor profiling service, and which national payers are relevant to coverage discussions. The publication summarizes reimbursement and policy considerations, common billing modifiers, typical site-of-service practices, and where stakeholders can expect PLA-specific coding implications to arise.
This resource is intended to clarify the clinical purpose of 0306U, its role in MRD workflows, and the payer landscape nationally. Data not available in the input for detailed payer-specific coverage policies, associated taxonomies, and ICD-10 pairings are noted as unavailable.
Billing Code Overview
CPT code 0306U is a Proprietary Laboratory Analyses (PLA) code reported only for the Invitae PCM Tissue Profiling and MRD Baseline Assay from Invitae Corporation. The test sequences the DNA of a tumor specimen to generate a tumor profile that serves as a baseline for subsequent testing to determine minimal residual disease (MRD) levels after treatment.
Service Type: Tumor DNA sequencing for MRD baseline profiling
Typical Site of Service: Clinical laboratory / specialized molecular pathology laboratory
Data not available in the input for Associated Taxonomies, ICD-10 Diagnoses, Related Codes, and Service Line.
Clinical & Coding Specifications
Clinical Context
A patient with a recently resected or biopsied solid tumor (for example, stage II–III colorectal adenocarcinoma or non‑small cell lung carcinoma) presents for baseline molecular profiling. The treating oncologist orders the Invitae PCM Tissue Profiling and MRD Baseline Assay to sequence the tumor specimen and generate a tumor profile that will serve as the baseline comparator for later plasma-based minimal residual disease (MRD) testing. The workflow: tumor tissue is obtained at surgery or diagnostic biopsy, sent to the pathology laboratory for formalin fixation and paraffin embedding, then a specimen or extracted nucleic acid is submitted to Invitae. Invitae performs targeted DNA sequencing, reports somatic variants and a personalized tumor profile, and provides the baseline signature for serial peripheral blood MRD monitoring. Results inform baseline tumor mutation profile, eligibility for targeted therapies, and the specific markers tracked on follow-up MRD assays.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
00 | Unmodified service | Use when no modifier is required and the PLA test is reported in standard fashion. |
26 | Professional component |