Additional PathVysion information

Reliable 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 helps enable the accurate assessment of a patient's HER-2 status at the DNA level with a high degree of accuracy and helps guide doctors to make the most appropriate therapy decisions based on the patient's own genetic profile.

 

PathVysion is one of the preferred tests for assessing HER-2 status1:

  • FISH is considered the gold standard for HER-2 testing1, 2, 3
  • Studies indicate FISH to accurately and reproducibly assess tumors for HER-2 status4
  • PathVysion exhibits better concordance than IHC between local and central laboratories1
  • The Chromosome 17 probe acts as an internal control and corrects for polysomy (identifies gene amplification versus chromosome 17 polysomy) and nuclear truncation1
  • FDA approved automated result scanning is available for PathVysion**

** http://www.fda.gov/Abbott AutoVysion approved Oct., 2004, Bioview Duet approved Oct. 2008, Ikonisys oncoFISH her2 approved Oct., 2008
 

 

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.

 
References

1. Sauter G, et al. Guidelines for Human Epidermal Growth Factor Receptor 2 Testing: Biologic and Methodologic Considerations. J Clin Oncol 27:1323-1333, 2009.
2. Mass 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.
3. Allison M, The HER2 testing conundrum. Nature Biotechnology 28 (2): 117-119, 2010.
4. Press 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.

 

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