Laboratory tests come into existence through a variety of processes but regardless of the genesis all share a certain set of requirements. These include discovery, development, validation, regulatory clearance and market adoption. ST2 is a protein biomarker that was discovered in a gene expression exploration analysis to be involved in cardiac disease and to potentially have clinical value in managing patients with cardiac disease. Following this discovery Critical Diagnostics developed an in vitro diagnostic assay to accurately measure ST2 and performed the necessary clinical studies to determine the clinical value proposition. This information was used to pursue and obtain regulatory approval and the test is now available in most of the world. This lecture will cover the processes and issues from taking a biomarker target from discovery through to commercialization.
Research And Development
Medical Laboratory Technician100%
Manufacturer - Other100%