Breast cancer is the most common type of cancer in women and is second only to lung cancer in cancer-related death.1 Approximately 20-25% of women with breast cancer have HER2 positive tumors.2 While HER2 positive tumors are seen as more aggressive, HER2 positive tumors are also candidates for targeted drug therapy.

In breast cancer cases, HER2 FISH analysis helps enable the accurate assessment of a patient's HER2 status at the DNA level, with a high degree of accuracy to guide the most appropriate therapy decisions based on the patient's own genetic profile.

Shows whether the cells have extra copies of the HER2 gene

Provides HER2 FISH analysis combined with IHC analysis of other key biomarkers (ER, PR, Ki67, and PD-L1)

A virtual image-based TC/PC FISH platform is available to Pathologists

Rapid turnaround time of 3-4 days

Recommended Use

The FDA approved PathVysion® HER2 DNA Probe Kit (PathVysion Kit) is designed to detect amplification of the HER2/neu gene via fluorescence in situ hybridization (FISH) in formalin-fixed, paraffin-embedded human breast cancer tissue specimens. Results from the PathVysion Kit are intended for use as an adjunct to existing clinical and pathologic information currently used as prognostic factors in stage II, node-positive breast cancer patients.

The PathVysion Kit is indicated as an aid in the assessment of patients for whom Herceptin® (trastuzumab) treatment is being considered.3

This test is available up front, or as a reflex after RosettaGX Cancer Origin™
has been run and breast cancer has been determined to be the primary tumor.


1. SEER Stat Fact Sheets: Breast Cancer. Surveillance, Epidemiology, and End Results Program Website. Available at: Updated April 22, 2015. Accessed September 24, 2015.
2. Sauter G, Lee J, Bartlett J, Slamon D, Press M. Guidelines for Human Epidermal Growth Factor Receptor 2 Testing: Biologic and Methodologic Considerations. J Clin Oncol. 2009;27(8):1323-1333.
3. PathVysion HER2 DNA Probe Kit (PathVysion Kit) [package insert]. Des Plaines, IL: Abbott Molecular Inc.; 2013.