FDA approves test that identifies Herceptin candidates

Share this content:

A new genetic test that will help health care providers determine whether women with breast cancer are eligible for treatment with trastuzumab (Herceptin) has been approved by the FDA (www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm259055.htm).

Inform Dual ISH (Ventana Medical Systems, Tucson, Arizona) allows for measurement of the number of copies of the HER2 gene in tumor tissue. Women with HER2-positive breast cancer can benefit from Herceptin. Approximately 20% of women diagnosed with breast cancer are HER2-positive.

Using the new test, lab personnel can count copies of the HER2 gene on chromosome 17 in a small sample of the breast tumor. A chemical stain causes copies of the HER2 gene to appear black and copies of chromosome 17 to appear red. These color changes can be seen under a standard microscope on the same slide, similar to HER2 amplification measurements that have traditionally only been available using fluorescence microscopes.

In a study of 510 women with breast cancer, the Inform Dual ISH test effectively confirmed abnormally high numbers of copies of the HER2 gene in 96% of the HER2-positive tumor samples. The test also was able to exclude the possibility of the presence of more than the normal number of copies of HER2 in 92.3% of the HER2-negative tumor samples.

You must be a registered member of ONA to post a comment.

Sign Up for Free e-newsletters

Regimen and Drug Listings


Bone Cancer Regimens Drugs
Brain Cancer Regimens Drugs
Breast Cancer Regimens Drugs
Endocrine Cancer Regimens Drugs
Gastrointestinal Cancer Regimens Drugs
Genitourinary Cancer Regimens Drugs
Gynecologic Cancer Regimens Drugs
Head and Neck Cancer Regimens Drugs
Hematologic Cancer Regimens Drugs
Lung Cancer Regimens Drugs
Other Cancers Regimens
Rare Cancers Regimens
Skin Cancer Regimens Drugs