This is a brief overview of information related to FDA’s approval to market this product.  See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.

Product Name:  VENTANA HER2 Dual ISH DNA Probe Cocktail
PMA Applicant:  Ventana Medical Systems, Inc.
Address:  1910 E. Innovation Park Drive, Tucson, AZ 85755
Approval Date:   July 28, 2020
Approval Letter:  Approval Order

What is it? The VENTANA HER2 Dual ISH DNA Probe Cocktail is a lab test that estimates the number of copies of the HER2 gene in breast cancer tissue samples to help doctors identify breast cancer patients who should be treated with the drug HERCEPTIN (transtuzumab).   It is a type of lab test called a companion diagnostic.

How does it work? A doctor takes a small amount of breast cancer tissue from a patient and sends it to a laboratory for testing. Test results are reviewed by a medical professional and a report is sent back to the patient’s doctor. If the test shows a higher level of the HER2 gene in the tissue sample the doctor may prescribe a drug that targets HER2-positive breast cancer, such as HERCEPTIN.

When is it used? The VENTANA HER2 Dual ISH DNA Probe Cocktail is used to test breast cancer tissue.

What will it accomplish? Test results from the VENTANA HER2 Dual ISH DNA Probe Cocktail are used to help doctors decide whether HERCEPTIN is a good treatment choice for their patient.

When should it not be used?  There are no known contraindications.

Additional information (including warnings, precautions, and adverse events):

• Summary of Safety and Effectiveness
• Labeling
• PMA Database Entry