Ordering Recommendation

Monitor therapy and identify disease recurrence in individuals with a metastatic breast cancer diagnosis. Do not use for diagnosis or screening of breast cancer.

New York DOH Approval Status

This test is New York state approved.

Specimen Required

Patient Preparation
Collect

Plain red or serum separator tube or EDTA plasma.

Specimen Preparation

Allow specimen to clot completely at room temperature. Separate serum from cells ASAP or within 2 hours of collection. Transfer 1 mL serum to an ARUP Standard Transport Tube. (Min: 0.5 mL)

Storage/Transport Temperature

Frozen.

Unacceptable Conditions
Remarks
Stability

After separation from cells: Ambient: 8 hours; Refrigerated: 7 days; Frozen: 3 months

Methodology

Quantitative Chemiluminescent Immunoassay

Performed

Sun-Sat

Reported

Within 24 hours

Reference Interval

Effective August 16, 2021
Less than or equal to 39 U/mL

Interpretive Data

Test Information: The CA 27.29 assay is intended for use in monitoring: 1) disease progression and/or response to therapy in patients with metastatic disease, and 2) disease recurrence in patients treated previously for stages II or III breast carcinoma who are clinically free of the disease. Serial testing in patients who are clinically free of disease should be used in conjunction with other clinical methods for early detection of cancer recurrence.

Limitations:
Patients with confirmed breast carcinoma frequently have CA 27.29 assay values in the same range as healthy individuals.  Elevations may also be observed in patients with non-malignant disease. Results of this test must always be interpreted in the context of morphologic and other relevant data and should not be used alone for a diagnosis of malignancy.

Methodology:
Siemens Atellica IM BR 27.29 (BR) chemiluminescent immunoassay was used. Results obtained with different assay methods or kits cannot be used interchangeably.

Compliance Category

FDA

Note

Hotline History

N/A

CPT Codes

86300

Components

Component Test Code* Component Chart Name LOINC
0080392 Cancer Antigen 27.29 17842-6
* Component test codes cannot be used to order tests. The information provided here is not sufficient for interface builds; for a complete test mix, please click the sidebar link to access the Interface Map.

Aliases

  • Breast Cancer Tumor Markers
  • Breast Carcinoma-Associated Antigen (CA 27.29), Serum
  • CA 27-29
  • CA 27.29
  • MAM 6
  • Milk Mucin
Cancer Antigen 27.29