HER2 Testing Methods

Extract

HercepTest: An IHC test using a goat polyclonal antibody. FDA approved the kit in September 1998 as an aid in determining which patients should be treated with Herceptin. Manufactured by DAKO Corporation, Glostrup, Denmark, and Carpinteria, Calif.

INFORM HER-2/neu Test: A FISH assay developed to help predict breast cancer recurrence. Approved in December 1997 by FDA to use along with other prognostic tests in lymph node-negative patients with primary, invasive, localized breast tumors. Developed by Oncor Inc., and acquired by Ventana Medical Systems Inc., Tucson, Ariz., in November 1998.

Path Vysion HER-2 DNA Probe Kit: A FISH assay developed specifically for predicting a patient’s response to doxorubicin. Approved by the FDA in December 1998 as an aid in determining the response of patients with node-positive, stage II breast cancer to cyclophosphamide, doxorubicin, and 5-fluorouracil (CAF). Manufactured by Vysis Inc., Downers Grove, Ill.