PathVysion HER-2 DNA Probe Kit (PathVysion Kit) is designed to detect amplification of the HER-2/neu gene via fluorescence in situ hybridization (FISH) in formalin-fixed, paraffin-embedded human breast cancer tissue specimens.
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 status:
FISH is considered the gold standard for HER-2 testing
Studies indicate FISH to accurately and reproducibly assess tumors for HER-2 status
PathVysion exhibits better concordance than IHC between local and central laboratories
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