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Test Name:
CA 27.29, by Chemiluminescence


  • SBMF No:
    30150
  • Performance Lab Name:
    Manual Lab
  • Test Mnemonic:
    CA 27.29-
  • ABN:
    May be required – Medical Necessity
  • CPT Code:
    86300
  • LOINC Code:
    17842-6
  • Also Known As:
    Tumor Marker, Breast Cancer
    Breast Cancer Marker
    Breast Cancer Tumor Marker
    Breast Carcinoma-Associated Antigen
    Tumor Marker
  • Spec Type:
    Serum
  • Spec Container:
    Gold top (SST) or red top (serum) tube
  • Pref Vol:
    1.0 mL
  • Min Vol:
    0.5 mL
  • Fasting:
    No
  • Spec Collect:
    Routine venipuncture
  • Spec Process:
    Clot 30 minutes
    Promptly centrifuge 15 minutes
    If sample not sent to SBMF on day collected:
         – Immediately transfer serum to separate plastic tube
         – Freeze and transport frozen
  • Spec Store Transport:
    Refrigerated (72 hours) or frozen
  • Spec Stability:
    72 hours refrigerated (2-8°C)
    Greater than 72 hours, freeze (-20°C) – Do not use frost-free units that undergo repeated freeze/thaw cycles
  • Methodology:
    Chemiluminescent Immunoassay (CLIA)
  • Use:
    An aid in the management of breast cancer patients with metastatic disease by monitoring the progression or regression of disease in response to treatment
       Note: SBMF provides serial reporting for this test at no additional charge
  • Clinical Significance:
    Breast cancer is the most common cancer among women in the United States. The vast majority of breast cancer deaths are from advanced disseminated disease. Although many therapeutic modalities exist for the treatment for metastatic disease, most breast cancers usually become refractory to specific drugs and require second and third line regimens. A circulating tumor marker, such as CA 27.29, which can monitor response to therapy and can indicate disease status is a valuable tool in the management of these patients.CA 27.29 is a highly polymorphic glycoprotein belonging to the mucin family and is the product of the MUC-1 gene. It is most useful using serial measurements to monitor both the course of disease and response to therapy because of the direct correlation of changing levels of CA 27.29 with clinical status. In patients with known metastases, a reduction in levels of this marker indicates a good response to treatment while increasing levels indicate resistance to therapy and progressive disease and justify further clinical evaluation and regular monitoring. It has also recently been shown that an elevation of CA 27.29 levels above the upper limit of normal in patients with no clinical evidence of disease is an early indicator of recurrence. An elevated serum CA 27.29 level in patients in remission of Stage II or III breast cancer provided a positive predictive value of 83.3% for recurrent disease, with an average lead time of 5.3 months before recurrence was clinically established.
  • Reference Range:
    Less than 38.6 U/mL
  • Additional Test Info:
    Limitations:
    Do not interpret levels of CA 27.29 as absolute evidence of presence of, or absence of malignant disease.
    Measurements of CA 27.29 should always be used in conjunction with other diagnostic procedures, including clinical evaluation
    Do not use this assay as a screening test or for diagnosis.
    Normal levels of CA 27.29 do not preclude the presence of disease
  • Day Run:
    Tue, Thu, Sat
  • Time Run:
    8:00 am
  • Time Reported:
    5:00 pm
  • Test Type:
    TUMOR MARKER