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Validation, Quality Control, Regulations -- Why?

Importance of Test Accuracy With all Tests, Including Predictive Markers
Physicians and patients rely on accurate diagnostic testing from the clinical and anatomic pathology laboratory. Analytical validation is essential to ensuring that an assay performs as expected and that it accurately identifies and/or quantifies measurable values or qualitative aspects associated with human disease. Established guidelines and stringent quality control are important for the reproducibility of test results.
Studies have revealed serious problems with validation consistency and discrepancies in test result between laboratories. This is a serious concern, but especially alarming when it affects predictive markers testing, since they directly affect clinical treatment decisions.
The American Society of Clinical Oncologists (ASCO), a guiding organization of medical oncologists, and the College of American Pathologists (CAP), have worked together to develop collaborative guidelines for use with predictive markers. The guidelines for predictive marker testing in anatomic pathology cover all aspects of laboratory practice, quality control, interpretation, and reporting. The hope was that collaborative and coordinated efforts would result in guidelines which would have the greatest impact in addressing concerns with test accuracy.