Breast specimens must have a cold ischemic time of <60 minutes proceeded by fixation in 10% neutral buffered formalin for 6-72 hours. (as per CAP/ASCO guidelines) Microwave processed and decalcified samples are not suitable for testing. Mercurochrome use as a dye marker is not recommended.
Testing for adult patients with HER2 negative, hormone receptor positive, node positive, early breast cancer at high risk of disease recurrence where Ki-67 directed therapy is being considered.
Biomarker: Ki-67
Formalin fixed paraffin embedded block or tissue sections cut at 4 microns mounted on "Superfrost Plus" charged slides.