Skip to main content
MJH Life Sciences
  • Login
  • Register
  • Login
  • Register
Home
  • ONCOLOGY
  • News
  • Blogs
  • Topics
  • Hematology
  • Image IQ
  • Podcasts
  • Videos
  • Slideshows
  • Conferences
MJH Life Sciences

SUBSCRIBE: Print / eNewsletter

HercepTest Identifies Breast Cancer Tumors That Overexpress HER2

October 1, 1998
Volume: 
7
Issue: 
10
  • Breast Cancer, HER2-Positive Breast Cancer

COPENHAGEN, Denmark--Dako Corporation’s HercepTest was
recommended unanimously for FDA approval by a joint committee of the
Hematology and Pathology Devices Panel and Immunology Devices Panel,
conditional on the company providing clear guidelines on how to
conduct the test, so that laboratories can provide consistent results.

The new immunohistochemical test was designed specifically to
identify patients with breast cancer whose tumor tissue overexpresses
the HER2 protein. It is a result of an agreement announced last March
in which Genentech, maker of Herceptin (trastuzumab), granted Dako a
license, under its patent rights, to develop the test. A positive
HercepTest result will aid in the assessment of patients with
metastatic breast cancer for whom treatment with Herceptin is being
considered. The Oncologic Drugs Advisory Committee (ODAC) has
recommended that Herceptin receive FDA approval .

During the Herceptin clinical trials, it was determined that a
simpler test was needed to identify patients who potentially could
benefit from the agent. Dako proposed to the FDA to develop a test
that, if successful, would reach or exceed a concordance level of 75%
when compared to the immunohistochemical assay applied in the
clinical trials for Herceptin. HercepTest exceeded its goal with a
concordance of 79% that was shown to be reproducible in and between labs.

The test is based on a polyclonal antibody developed by Dako for
specific detection of the HER2 protein. The antibody is applied to
the tissue, and its binding is visualized to indicate the level of
antigen in the tissue (figure). [An
available HER2 test kit, Oncor Inc.’s Inform, counts copies of
the HER2 gene, rather than measuring the protein level.]

The Dako test is easy to conduct, since it requires relatively few
steps and uses equipment routinely found in pathology laboratories.
It requires about 3 hours to stain specimens of paraffin-embedded
tissue, which is then evaluated by the pathologist against a
predetermined scoring system. (In the figure, the top two sample
stains are rated negative and the bottom two are rated positive).

Related Articles

  • Long-Term Follow-Up Supports Anastrozole Treatment to Prevent Breast Cancer Recurrence
  • Addition of S-1 to Endocrine Therapy Postoperatively Improves Survival in HR+, HER2- Breast Cancer
  • Addition of Pertuzumab to Previous Standards Improves IDFS in HER2+ Breast Cancer
  • Trastuzumab Deruxtecan Shows Promise in Heavily Pretreated Patients With HER2+ BC
  • FDA Approves Abbreviated New Drug Applications for Everolimus Generic Drug

Resource Topics rightRail

  • Resource Topics
  • Partner Content
  • Breast Cancer
  • Acute Myeloid Leukemia
  • HER2-Positive Breast Cancer
  • Videos Breast Cancer
  • Follicular Lymphoma
Cutaneous T-Cell Lymphomas: Mycosis Fungoides and Sézary Syndrome
3 Keys to Success in the Oncology Care Model

Current Issue

ONCOLOGY Vol 33 No 11
Nov 21, 2019 Vol 33 No 11
Subscribe
Connect with Us
  • Column 1
    • Home
    • About Us
    • Contact Us
  • Column 2
    • Editorial Info
    • Editorial Board
  • Column 3
    • Advertising Info
    • Reprints
    • Advertising Terms
  • Column 4
    • Terms of Use
    • Privacy Policy
Modern Medicine Network
© UBM 2019, All rights reserved.
Reproduction in whole or in part is prohibited.

We've noticed that you're using an ad blocker

Our content is brought to you free of charge because of the support of our advertisers. To continue enjoying our content, please turn off your ad blocker.

It's off now Dismiss How do I disable my ad blocker?
❌

How to disable your ad blocker for our site:

Adblock / Adblock Plus
  • Click on the AdBlock / AdBlock Plus icon on the top right of your browser.
  • Click “Don’t run on pages on this domain.” OR “Enabled on this site.”
  • Close this help box and click "It's off now".
Firefox Tracking Prevention
  • If you are Private Browsing in Firefox, "Tracking Protection" may casue the adblock notice to show. It can be temporarily disabled by clicking the "shield" icon in the address bar.
  • Close this help box and click "It's off now".
Ghostery
  • Click the Ghostery icon on your browser.
  • In Ghostery versions < 6.0 click “Whitelist site.” in version 6.0 click “Trust site.”
  • Close this help box and click "It's off now".
uBlock / uBlock Origin
  • Click the uBlock / uBlock Origin icon on your browser.
  • Click the “power” button in the menu that appears to whitelist the current website
  • Close this help box and click "It's off now".