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The page below is a sample from the LabCE course Breast Cancer Predictive Markers. Access the complete course and earn ASCLS P.A.C.E.-approved continuing education credits by subscribing online.

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Validation, Quality Control, Regulations -- Why?

Physicians and patients rely on accurate diagnostic testing from the clinical and anatomic pathology laboratories. Analytical validation is essential to ensure 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 inconsistencies with test validations and test results between laboratories. This is a serious concern, but especially alarming when it affects predictive marker tests, 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 cover all aspects of laboratory testing, including, quality control, interpretation, and reporting. The hope is that these collaborative and coordinated efforts will effectively address concerns with test accuracy.