Proliferation Marker Ki67, Paraffin Block

CPT: 88360
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Synonyms

  • Ki67

Special Instructions

Please direct any questions regarding this test to oncology customer service at 800-345-4363.


Expected Turnaround Time

5 - 9 days


Specimen Requirements


Specimen

Formalin-fixed, paraffin-embedded (FFPE) tumor


Volume

One paraffin block


Container

Paraffin block transport pouch


Collection

Specimen should be fixed in 10% neutral-buffered formalin. Optimum fixation time is 12 to 24 hours, not to exceed 48 hours.


Storage Instructions

Maintain specimen at room temperature.


Test Details


Use

Cancer prognosis: Evaluation of cellular proliferation in tumors which, when combined with other prognostic markers can provide information for patient management and therapy.


Limitations

Use of fixatives other than 10% formalin may not yield equivalent or satisfactory results.

This procedure may be considered by Medicare and other carriers as investigational and, therefore, may not be payable as a covered benefit for patients.


Methodology

Immunohistochemistry (IHC)


Additional Information

Studies have shown a strong correlation between proliferation rate and clinical outcome in a variety of tumor types, and measurement of cell proliferative activity is one of several important prognostic markers.1 A high level of staining for this nuclear proliferation marker in breast carcinomas is associated with an increased risk of early recurrence.2-4


Footnotes

1. Hall PA, Levison DA. Assessment of cell proliferation in histologic material. J Clin Pathol. 1990 Mar; 43(3):184-192 (review). 2185282
2. Bouzubar N, Walker KJ, Griffiths K, et al. Ki67 immunostaining in primary breast cancer: Pathological and clinical associations. Br J Cancer. 1989 Jun; 59(6):943-947. 2472168
3. Veronese SM, Gambacorta M. Detection of Ki67 proliferation rate in breast cancer. Correlation with clinical and pathologic features. Am J Clin Pathol. 1991 Jan; 95(1):30-34. 1987749
4. Fitzgibbons PL, Page DL, Weaver D, et al. Prognostic factors in breast cancer. College of American Pathologists Consensus Statement 1999. Arch Pathol Lab Med. 2000 Jul; 124(7):966-978. 10888772

LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
481051 Prolif Marker MIB-1, Paraffin 481060 % Positive Tumor Nuclei % 29593-1
481051 Prolif Marker MIB-1, Paraffin 481130 Comment: 77202-0

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