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Ki-67 IHC pharmDx (Abemaciclab) with Interpretation
Test Code11800
CPT Codes
88360
Preferred Specimen
1 block tissue collected in a formalin-fixed, paraffin- embedded tissue block
Other Acceptable Specimens
5 unstained, positive (+) charged slides
Instructions
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.
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.
Transport Temperature
Room temperature
Specimen Stability
Room temperature: Preferred
Refrigerated: Acceptable
Frozen: Unacceptable
Refrigerated: Acceptable
Frozen: Unacceptable
Methodology
Immunohistochemistry
Setup Schedule
Set up: Mon-Sat; Report available: 3-5 days
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%.
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%.
