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The amount of published literature on biomarkers has exponentially increased over the last two decades. Cancer biomarkers are molecules that are either part of tumour cells or secreted by tumour cells. Biomarkers can be used for diag- nosing cancer (tumour versus normal and differentiation of subtypes), prognos- ticating patients (progression free survival and overall survival) and predicting response to therapy. However, very few biomarkers are currently used in clinical practice compared to the unprecedented discovery rate. Some of the examples are: carcino-embryonic antigen (CEA) for colon cancer; prostate specific antigen (PSA) for prostate; and estrogen receptor (ER), progesterone receptor (PR) and HER2 for breast cancer.
Cancer biomarkers passes through a series of phases before they are used in clinical practice. First phase in biomarker development is identification of bio- markers which involve discovery, demonstration and qualification. This is fol- lowed by validation phase, which includes verification, prioritisation and initial validation. More large-scale and outcome-oriented validation studies expedite the clinical translation of biomarkers by providing a strong "˜evidence base'. The final phase in biomarker development is the routine clinical use of biomarker.
In summary, careful identification of biomarkers and then validation in well-de- signed retrospective and prospective studies is a systematic strategy for devel- oping clinically useful biomarkers.
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