Dako HER2 FISH pharmDx™ - P040005/S005
This medical device was FDA approved on October 20, 2010.
The HER2 FISH pharmDx™ is a lab test that uses fluorescent dye to detect the HER2 gene located on Chromosome #17. The tagged DNA probes attach themselves allowing the detection of the gene. The method is also known as the FISH or fluorescent in situ hybridization method.
The method has been used for the detection of breast cancer and now has the new indication for detecting metastatic (spreading) stomach cancer.
Fig.1 Fish or fluorescent in situ hybridization method – allows researchers to visualize the genetic material in a subject’s cells. It has the specificity of single gene or even segments of a gene which is referred to Locus specific probes. It doesn’t have to be performed on cells that are actually undergoing division.
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