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Test ID C2729 Breast Carcinoma-Associated Antigen (CA 27.29), Serum

Secondary ID

81413

Useful For

FDA-approved cancer-associated antigen (CA 27.29) for serial testing in women with prior stage II or III breast cancer who are clinically free of disease

 

Predicting early recurrence of disease in women with treated carcinoma of the breast

 

As an indication that additional tests or procedures should be performed to confirm recurrence of breast cancer

Method Name

Chemiluminometric Immunoassay

Reporting Name

Breast Carcinoma Assoc Ag(CA 27.29)

Specimen Type

Serum

Collection Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Submission Container/Tube: Plastic vial

Specimen Volume: 0.5 mL

Collection Instructions:

1. Serum gel tubes should be centrifuged within 2 hours of collection.

2. Red-top tubes should be centrifuged and aliquoted within 2 hours of collection.

Forms: If not ordering electronically, complete, print, and send 1 of the following forms with the specimen:

1. General Request Form (T239) (http://www.mayomedicallaboratories.com/it-mmfiles/general-request-form.pdf)

2. Oncology Test Request Form (T729) (http://www.mayomedicallaboratories.com/it-mmfiles/oncology-request-form.pdf)

Specimen Minimum Volume

0.25 mL

Specimen Stability Information

Specimen Type Temperature Time
Serum Frozen (preferred) 90 days
  Refrigerated  7 days
  Ambient  4 days

Clinical Information

Carcinoma of the breast is the most prevalent form of cancer in women. These tumors often produce mucinous antigens that are large-molecular-weight glycoproteins with O-linked oligosaccharide chains.

 

Monoclonal antibodies directed against these antigens have been developed, and several immunoassays are available to quantitate the levels of tumor-associated mucinous antigens in serum. The antibodies recognize epitopes of a breast cancer-associated antigen encoded by the human mucin 1 (MUC-1) gene, which is known by several names including MAM6, milk mucin antigen, CA 27.29, and cancer antigen 15-3 (CA 15-3).

 

While CA 27.29 is expressed at the apical surface of normal epithelial cells, it is present throughout malignant epithelial cells of the breast, lung, ovary, pancreas, and other sites. The cancer-associated form of the antigen is less extensively glycosylated than the normal form and more specific for tumor cells.

Reference Values

Males

≥18 years: ≤38.0 U/mL (use not defined)

Females

≥18 years: ≤38.0 U/mL

Reference values have not been established for patients who are <18 years of age.

Serum markers are not specific for malignancy, and values may vary by method.

Cautions

This test provides results on female patients only at this time.

 

The use of cancer-associated antigen (CA 27.29) has not been demonstrated to provide clinical benefit to these patients, which has led some Mayo clinical investigators to conclude there is insufficient justification for routine clinical use of this new marker.

 

Measurement of CA 27.29 is not useful to screen women for carcinoma of the breast.

 

Some patients who have been exposed to mouse antigens, either in the environment or as part of treatment or imaging procedure, may have circulating antimouse antibodies present. These antibodies may interfere with the assay reagents to produce unreliable CA 27.29 results.

Day(s) Performed

Monday through Friday; 8:30 p.m.-6 a.m.

Report Available

Same day/1 day

Performing Laboratory

Mayo Medical Laboratories in Rochester

Test Classification

This test has been cleared or approved by the U.S. Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.

CPT Code Information

86300

NY State Approved

Yes