Why PathVysion?

The PathVysion HER-2 DNA Probe Kit is a vital tool in the fight against breast cancer. It is a precise test that provides clinicians and their patients with accurate and reliable HER-2 results.

The PathVysion HER-2 DNA probe kit is one of the first examples of what is recognized as genomic disease management, or personalized medicine. This means that the test enables the accurate assessment of a patient's HER-2 status at the DNA level and guides doctors to make the most appropriate therapy decisions based on the patient's own genetic profile.

PathVysion is approved by the U.S Food and Drug Administration (FDA) for use as an aid in determining prognosis, and assisting with adriamycin-based chemotherapy selection and Herceptin® (Trastuzumab) monoclonal antibody therapy selection. It is not intended for use in screening for or diagnosing breast cancer.

PathVysion is the best test for assessing HER-2 status:

  • Patients with gene amplification by PathVysion have greater responsiveness to Herceptin than patients with overexpression by IHC1, 2
  • FISH is considered the gold standard for HER-2 testing.3
  • Studies indicate superiority of FISH to accurately and reproducibly assess tumors for HER-2 status.4
  • PathVysion is the only HER-2 test (IHC or FISH) commercially available with data tied to patient outcomes
  • PathVysion exhibits better concordance than IHC between local and central laboratories
  • Interpretation of PathVysion  results is objective
  • The Chromosome 17 probe acts as an internal control and corrects for polysomy (identifies gene amplification versus chromosome 17 polysomy) and nuclear truncation
  • FDA approved automated result scanning is available for PathVysion
  • Abbott Molecular is the clear leader in FISH technology

PathVysion direct labeled FISH probes yield definitive results at the molecular level. The test uses fluorescent probes to "paint" the HER-2 genes in the tumor cell nucleus, to see if the number of gene copies is normal or not. Interpretation is objective - results are obtained by counting the fluorescent signals (dots). In addition, because this test measures genetic material, which is very stable, tissue preparation has very little effect on test outcome.


1Vogel C, et al. Superior outcomes with Herceptin (Trastuzumab) in FISH selected patients. Proc Am Soc Clin Oncol. 2001: 20:22a. Abstract 86 and Presentation.
2Mass R, et al. Evaulation of Clinical Outcomes According to HER-2 Detection by Fluorescence in situ Hybridization in Women with Metastatic Breast Cancer Treated with Trastuzumab. Clnical Breast Cancer, vol 6, No. 3, 240-246, 2005.
3National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology, Breast Cancer V.I.2007.
4Press M, et al. Diagnostic Evaulation of Her-2 as a Molecular Target: An Assessment of Accuracy and Reproducibility of Laboratory Testing in Large, Prospective Randomized Clinical Trials, Clinical Cancer Research 2005; 11(18) September 15, 2005.