The IHC Breast Multiplex assay is intended for the qualitative identification of Keratin 5/14, p63 protein and Keratin 7/18 by two color immunohistochemistry (IHC). This multiplex assay has two diagnostic applications:
1. Invasive carcinoma versus non-invasive lesions: The presence of myoepithelial cells around suspicious cells nests argues against a diagnosis of invasive carcinoma and can aid in identifying a non-invasive entity, such as carcinoma in situ, atypical ductal hyperplasia (ADH), usual ductal hyperplasia (UDH), and sclerosing adenosis.
2. Usual ductal hyperplasia versus atypical ductal hyperplasia and carcinoma in situ: The presence of staining for Keratin 5 among the luminal cells of a hyperplastic breast lesion can aid in distinguishing usual ductal hyperplasia (typically positive for Keratin 5) from atypical ductal hyperplasia/carcinoma in situ (typically negative for Keratin 5).
CPT Code(s): 88344 (reference only; CPTs may vary)
Turnaround Time: Within 1-2 business days of receipt
Schedule: Monday - Friday
• Formalin-fixed, paraffin-embedded (FFPE) tissue block or cell block - OR -
• 1 unstained slide for each test requested plus 3-4 additional unstained slides cut at 4µm