Breast cancer remains the only major cancer for which certain treatments are routinely determined by certain prognostic factors. Currently, commercial prediction technology is divided into four main platforms, immunohistochemical assay (IHC), fluorescence in situ hybridization (FISH) technique, genomic analysis, and quantitative immunofluorescence. Immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH)-based assays currently dominate the breast cancer diagnostic landscape.
In this context, these two techniques are most often used to assess the status of HER-2 or hormone receptors. Evaluation of test of 'tumorous tissue specimens' results allow doctors to properly select patients who may benefit from appropriate therapy. This market is currently dominated by large, well-established companies that offer FDA-approved products.
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At the time, genomic analysis was mostly used to determine cancer recurrence and relapse, although an expansion of predictable analysis is ongoing. This laboratory analysis is currently the domain of small and medium enterprises. Recently, fluorescence-labeled antibody tests have been introduced to measure the amount of protein associated with the effect of a particular drug. This test can help doctors determine which medications are most likely to be effective for a particular patient.
IHC is the process of localizing proteins in tissue cells with the principle of binding antibodies to specific antigens. Generally, IHC tests are FDA approved and are sold in the relatively low price range of $200 to $400. This test is performed routinely in many pathology laboratories. The prognostic value of IHC is well established for HER-2 and the estrogen receptor (ER) but has not been established as a predictor of cytotoxic drug efficacy.