Why PathVysion may be right for you
The PathVysion HER-2 test 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 helps guide doctors to make the most appropriate therapy decisions based on a 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 has been proven to be the best test for assessing HER-2 status:
- Patients exhibiting gene amplification through testing by PathVysion have greater responsiveness to Herceptin than patients exhibiting overexpression through testing 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
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. Evaluation of Clinical Outcomes According to HER-2 Detection by Fluorescence in situ Hybridization in Women with Metastatic Breast Cancer Treated with Trastuzumab. Clinical 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 Evaluation 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.
