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    v1.0.31
    OpenPayerBilling CodesProprietary Laboratory AnalysesCPT cpt-0307u-invitae-pcm-mrd-ctdna-monitoring
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    CPT 0307U: Invitae PCM MRD Monitoring (ctDNA)

    CPT code 0307U is a Proprietary Laboratory Analyses (PLA) test specific to Invitae Corporation that evaluates a patient blood specimen for circulating tumor DNA (ctDNA) matching a tumor profile previously identified by 0306U; the service is used for minimal residual disease (MRD) detection and surveillance to identify presence of cancer cells after treatment. The service type is molecular pathology / ctDNA MRD monitoring, and the typical site of service is clinical laboratory or outpatient phlebotomy/infusion center where blood specimens are collected and sent to the performing laboratory.

    For related coverage guidance, see recent payer policy updates: Minimal Residual Disease (MRD) Testing for Cancer, Biomarker Testing Mandate, Prenatal (Fetal) Diagnostic Testing.

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    Table of contents

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    Clinical & Coding Specifications

    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.

    Related CPT Codes

    CPT CodeDescriptionRelationship to This Procedure
    0306UInvitae 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
    86316Antigen; tumor (antigen detection by immunoassay)General tumor marker assays that may be ordered alongside ctDNA monitoring for broader surveillance
    88172Cytopathology, fluid, washings, or brushings; immediate interpretationRapid cytologic assessment that may precede or follow imaging prompted by MRD positivity
    84153Prostate specific antigen (PSA)Example organ-specific tumor marker commonly used with MRD testing in prostate cancer surveillance
    81479Unlisted molecular pathology procedureUsed occasionally for reporting ancillary or custom molecular testing not covered by a PLA when additional non-proprietary analyses are performed

    Related Modifiers

    6 rows

    ModifierDescriptionWhen to Use
    26Modifier 26 (Professional Component) identifies and bills only the professional portion of a split service — the physician’s interpretation, report, and medical judgment — when the technical…- Use CPT Modifier -26 when you are billing only the professional component (PC) of a split‑bill eligible service—i.e., you performed the physician interpretation, medical judgment and prepared a…
    52Modifier ‑52 (Reduced Services) indicates that a service or procedure was partially reduced or omitted at the provider’s discretion, allowing reporting of the basic procedure number with a qualifier…- Use modifier -52 when a physician or qualified health professional electively reduces or omits part of a procedure or service (for example, performing fewer required views or omitting a portion of…
    53Modifier 53 (Discontinued Procedure) signals that a surgical or diagnostic service was begun by the physician but terminated because of extenuating circumstances that threatened the patient’s…- Use modifier -53 when a physician/qualified healthcare professional has started a surgical or diagnostic procedure (e.g., anesthesia administered, incision or scope insertion) and then discontinues…
    62Modifier 62 indicates that two surgeons function as co‑surgeons, each performing distinct parts of the same primary surgical procedure. It is appended to the primary procedure code (and any…- Use modifier -62 when two surgeons act as co‑surgeons (both primary surgeons) on a single definitive primary procedure, each performing distinct parts of the same surgical procedure (append -62 to…
    78CPT modifier -78 indicates an unplanned, related return to the operating or procedure room by the same provider during the global postoperative period. It is appended when treatment for a…- Use modifier -78 when an unplanned, related complication during the original procedure’s global postoperative period requires the patient to return to a formal operating or procedure room and the…
    80CPT® Modifier 80 (Assistant Surgeon) is appended to a surgical CPT code when a physician (MD or DO) provides full, continuous assistance throughout the operative procedure. It is intended only for…- Use CPT Modifier -80 when a physician (MD or DO) serves as an assistant surgeon and provides full, continuous assistance throughout the entire operative procedure; append -80 to the surgical CPT…

    Related Provider Taxonomies

    8 rows

    Taxonomy Code
    207K00000X
    207L00000X
    363L00000X
    344600000X
    224900000X
    2472D0500X
    347B00000X
    207VH0002X

    Related ICD-10-CM Codes

    27 rows

    ICD-10-CM CodeDescription
    C16.9Malignant neoplasm of stomach, unspecified
    C18.9Malignant neoplasm of colon, unspecified
    C22.0Liver cell carcinoma
    C25.9Malignant neoplasm of pancreas, unspecified
    C34.90Malignant neoplasm of unspecified part of unspecified bronchus or lung
    C43.9Malignant melanoma of skin, unspecified
    C50.912Malignant neoplasm of unspecified site of left female breast
    C56.9Malignant neoplasm of unspecified ovary
    C61Malignant neoplasm of prostate
    C64.9Malignant neoplasm of unspecified kidney, except renal pelvis

    Showing 1–10 of 27

    Related Payer Policy Updates

    Specialty: Genetic & Molecular Testing1 / 3

    10 rows

    PolicyPayerEffective Date
    Minimal Residual Disease (MRD) Testing for Cancerregence2027-01-01
    Biomarker Testing MandateBlue Cross Blue Shield - Rhode Island2027-01-01
    Prenatal (Fetal) Diagnostic TestingBlue Cross Blue Shield - Rhode Island2027-01-01
    Oral Cancer Screening and TestingOscar Health2027-01-01
    RTM Testing for Alpha-1 Antitrypsin DeficiencyOscar Health2027-01-01
    Cytochrome P450 Genotype-Guided Treatment Strategy Corporate Medical Policybcbsvermont2027-01-01
    Polygenic Risk ScoreBlue Cross Blue Shield - Rhode Island2026-12-01
    Gene Expression Profiling for Cutaneous MelanomaBlue Cross Blue Shield - Rhode Island2026-12-01
    Genetic Testing for Macular Degenerationregence2026-11-01
    Pharmacogenetic Panel Testing (for Ohio Only)Colorado Rocky Mountain Health Plans2026-11-01

    Related Codes

    CPT-0001U-PRECISETYPE-HEA-MULTIPLEX-RBC-ANTIGEN-GENOTYPING

    CPT 0001U: PreciseType HEA Erythrocyte Antigen Genotyping

    CPT-0002U-POLYPDX-URINE-METABOLOMIC-ASSAY-ADENOMATOUS-POLYP-RISK

    CPT 0002U: PolypDX™ Urine Metabolomic Risk Assay

    CPT-0003U-OVAR-A-NEXT-GENERATION-OVARIAN-CANCER-RISK-ASSAY

    CPT 0003U: Overa (MIA2G) Ovarian Cancer Risk Assay

    CPT-0005U-PROSTATE-EXOSOMEDX-INTELLISCORE-GENE-EXPRESSION-URINE-TEST

    CPT 0005U: ExosomeDx Prostate (IntelliScore) urine gene expression test

    CPT-0007U-TOXPROTECT-URINE-DRUG-SCREEN-WITH-DNA-AUTHENTICATION

    CPT 0007U: ToxProtect Urine Drug Screen With DNA Authentication

    CPT-0008U-H-PYLORI-ANTIBIOTIC-RESISTANCE-SEQUENCING-PANEL

    CPT 0008U: H. pylori Antibiotic Resistance Gene Panel

    CPT-0009U-DEPARRAY-HER2-FISH-TUMOR-CELL-ISOLATION

    CPT 0009U: DEPArray HER2 Tumor‑Cell Isolation with FISH Analysis

    CPT-0010U-BACTERIAL-TYPING-WHOLE-GENOME-SEQUENCING-MAYO-CLINIC

    CPT 0010U: Bacterial Typing by Whole Genome Sequencing, Mayo Clinic

    CPT-0011U-CORDANT-CORE-ALGORITHMIC-ORAL-FLUID-DRUG-TEST

    CPT 0011U: Oral Fluid Drug Test with Algorithmic Steady‑State Comparison

    CPT-0016U-BCR-ABL1-MAJOR-MINOR-FUSION-TRANSCRIPT-TESTING

    CPT 0016U: BCR–ABL1 Major and Minor Breakpoint Fusion Transcripts

    Showing 1–10 of 536

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    Frequently Asked Questions

    References

    1. 1.CPT® Codes and Descriptions. AAPC. Retrieved Aug 11, 2026.Maintains the CPT code set's official descriptions and guidelines, licensed from the American Medical Association, used as the definitional source for CPT codes on this page.
    2. 2.HCPCS Quarterly Update. Centers for Medicare & Medicaid Services (CMS). Retrieved Aug 11, 2026.CMS's quarterly release of HCPCS Level II codes and short/long descriptors, the source for HCPCS code definitions and update history.
    3. 3.ICD-10-CM Full Code List. Centers for Medicare & Medicaid Services (CMS). Retrieved Aug 11, 2026.CMS's complete ICD-10-CM diagnosis code list, used to cross-reference diagnosis codes associated with this procedure or service.
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