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    v1.0.31
    OpenPayerBilling CodesProprietary Laboratory AnalysesCPT cpt-0404u-divitum-tka-thymidine-kinase-activity-serum-assay
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    CPT 0404U: Thymidine Kinase Activity Assay for Breast Cancer Monitoring

    CPT code 0404U is a Proprietary Laboratory Analyses (PLA) code for DiviTum®TKa (Biovica Inc.), an immunoassay performed on a serum specimen to measure thymidine kinase activity as a marker of cell proliferation for monitoring treatment response in female patients with metastatic hormone‑positive breast cancer; this service is a laboratory diagnostic assay typically performed in a clinical laboratory or reference lab and reported using the PLA CPT code 0404U.

    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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    Clinical & Coding Specifications

    Clinical Context

    A 62-year-old woman with metastatic hormone receptor–positive (estrogen and/or progesterone receptor positive), HER2-negative breast cancer is undergoing systemic endocrine therapy with or without targeted agents. The treating oncologist orders the DiviTum® TKa test (0404U) using a serum specimen to measure thymidine kinase activity as a biomarker of tumor cell proliferation. Blood draw for the serum assay is typically performed at the outpatient oncology clinic or an ambulatory phlebotomy site on the day of a routine clinic visit or at a laboratory collection center. The specimen is sent to the manufacturer-designated laboratory or reference lab performing the proprietary immunoassay. Results are received electronically and used by the oncologist to monitor treatment response and inform discussions about ongoing systemic therapy effectiveness during follow-up visits. Typical workflow steps: 1) order placed in the electronic medical record for 0404U; 2) outpatient phlebotomy collects a serum specimen following standard venipuncture; 3) specimen is labeled, processed, and shipped per lab instructions to the performing laboratory; 4) laboratory performs the immunoassay and algorithmic analysis; 5) result report is returned to the ordering clinician and documented in the medical record; 6) clinician reviews results with the patient to assess proliferation trends and treatment effectiveness.

    Related CPT Codes

    CPT CodeDescriptionRelationship to This Procedure
    0404UDiviTum® TKa (thymidine kinase activity) assay, serum, immunoassay with algorithmic analysis (Proprietary Laboratory Analyses)Primary code for the proprietary serum thymidine kinase activity test used to monitor cell proliferation in metastatic hormone-positive breast cancer.
    36415Collection of venous blood by venipuncturePerformed at the outpatient clinic or phlebotomy center to obtain the serum specimen required for 0404U testing.
    80053Comprehensive metabolic panel (CMP)Common laboratory panel ordered alongside tumor monitoring tests to assess organ function before or during systemic therapy.
    85027Complete blood count (CBC) with automated differentialFrequently ordered in oncology follow-up to monitor hematologic status concurrent with biomarker testing.
    85025Complete blood count (CBC) without differentialAlternative CBC code used based on clinical need when differential is not required.
    81479Unlisted molecular pathology procedureOccasionally used for additional non-standardized molecular analyses when no specific CPT exists; may be performed in parallel with proprietary assays depending on clinical need.

    Related Modifiers

    5 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…
    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…
    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…

    Related Provider Taxonomies

    8 rows

    Taxonomy Code
    207RG0100X
    207RH0000X
    364S00000X
    207Q00000X
    207ZP0101X
    1835P1300X
    163WC3500X
    2085P0229X

    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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