Find Locations
For hours, walk-ins and appointments.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
Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.
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 |
© 2021 Laboratory Corporation of America® Holdings and Lexi-Comp Inc. All Rights Reserved.
CPT Statement/Profile Statement
The LOINC® codes are copyright © 1994-2021, Regenstrief Institute, Inc. and the Logical Observation Identifiers Names and Codes (LOINC) Committee. Permission is granted in perpetuity, without payment of license fees or royalties, to use, copy, or distribute the LOINC® codes for any commercial or non-commercial purpose, subject to the terms under the license agreement found at https://loinc.org/license/. Additional information regarding LOINC® codes can be found at LOINC.org, including the LOINC Manual, which can be downloaded at LOINC.org/downloads/files/LOINCManual.pdf