FISH for HER2/Neu (ERBB2)


CMCD performs the FDA-approved PathVysion® HER-2 FISH which was found to be the “most accurate, reproducible, and precise assay for assessment of known HER-2-overexpressing breast cancers.

According to the American Cancer Society, about 15% to 30% of people with breast cancer test positive for HER2. HER2-positive breast cancer contains a protein called human epidermal growth factor receptor – 2 (HER2). HER2 promotes the growth of cancer cells and increases the likelihood of faster growth and recurrence than other types of tumors.

ERBB2 testing is used to predict 5-year disease-free and overall survival in patients with breast cancer, assess eligibility for trastuzumab (Herceptin®) treatment, assist in dose selection for certain drugs, and predict response to drug therapies.

Collection Method

Type: Tumor Tissue
Preparation: Formalin fix (10 percent neutral buffered formalin) and paraffin embed tissue within 30 minutes of removal from patient. Fixative duration: 8-48 hours. Transport tissue block or 10 unstained (3-to 5-micron thick sections), positively charged slides in a tissue transport kit
Transport Temperature: Room temperature or refrigerated. Ship in cooled container during summer months.

When compared with PathVysion, a study found the HER-2 FISH pharmDx kit to be less than 95% concordant