Ki-67 IHC pharmDx (abemaciclab) with Interpretation

Last Modified: 8/23/2023 10:07:37 AM


Medical Necessity Documentation:  
Client Notes:  
Patient Preparation:  
Specimen Requirements: 1 block tissue collected in a formalin-fixed, paraffin-embedded tissue block
Collection Instructions: The pathology report that corresponds with the specimen that documents the ER, PR, HER2 results.

Please submit a copy of the pathology report.

Send specimen to lab for testing determination. 

Do not freeze. Do not reject.

Fixation in 10% neutral buffered formalin between 6 and 72 hours is recommended. Tissues processed with other fixatives and other fixation times have not been validated and are not recommended. Other tissue preparations (e.g., cytology specimens, fine-needle aspirates or bone decalcifications) have not been validated.
Minimum Volume: 1 Block or 4 USS
Transport & Storage: Temperature/Stability: Ambient Preferred
Refrigerated Acceptable
Frozen Unacceptable
Use cold pack for transport. Make sure cold pack is not in direct contact with specimen
Rejection Criteria: Frozen
Reference Range: Refer to Interpretive Pathology Report
Critical Ranges:  
Test Comments:  
Methodology: Immunohistochemistry (IHC)
Clinical Significance: Ki-67 IHC pharmDx (abemaciclab) is FDA-approved as an aid in identifying patients who specifically have HR-positive/ HER2-negative/node-positive breast cancer at high risk of disease recurrence and who are being considered for adjuvant treatment with Verzenio® (abemaciclib) in combination with endocrine therapy.
Ki-67 protein expression in breast carcinoma is determined by using the Ki-67 pharmDx Score, which is the overall percentage of viable tumor cells in the invasive cancer component showing Ki-67 nuclear staining. The specimen should be considered to have Ki-67 expression if Ki-67 pharmDx Score is > or = 20%. 
Documentation:  
Custom Panel: No

PRODUCTION SCHEDULE

Turn Around Time: 3 to 5 days
Days Performed: Monday, Tuesday, Wednesday, Thursday, Friday, Saturday
Sites Performed: Quest - Chantilly to PhenoPath
PHL Test Code: MSOT
EPIC Test Code: MISC
Send Out Test Code: 11800
Alternate Test Names: Abemaciclib; CDK4_6; KI67 pharmDx; MIB-1; Verzenio
Included Tests:  
CPT Coding: 88360

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