The FDA-approved Thermo Scientific Spot-Light HER2 CISH Kit is designed to allow users to perform an HER2 assay analogous to routine immunohistochemistry (IHC) that provides reliable gene status information and improves on the results obtained by fluorescent in situ hybridisation (FISH).
Current FDA-approved HER2 evaluation processes for screening breast cancer patients likely to respond to Herceptin therapy are FISH and IHC. The kit is claimed to have advantages to both of these methods.
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Proteomics International PromarkerD LDT immunoassay (ELISA)
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