In-vitro Diagnostics & Biomarkers

An IVD Medical Device defined as a device which, whether used alone or in combination for the in-vitro examination of specimens derived from the human body solely or principally to give information for diagnostic, monitoring or compatibility purposes. Biomarkers can be a substance used for examining organ function and condition. There are two major types of biomarkers: biomarkers of exposure, that are used in risk prediction, and biomarkers of disease, that are used in screening, diagnosis and monitoring of disease progression. Additional potential of molecular biomarkers is to identify individuals susceptible to disease. Examples of Biomarkers body temperature for fever, cholesterol for heart stroke, C-reactive protein for inflammation.