![]() When the result of a companion diagnostic test such as Herceptest® functions as a gateway to targeted therapy, artifactually induced false negative test results could incorrectly rule out treatment with a potentially life-saving drug – a devastating consequence. For example, one research group has shown that a delay in time to stabilization (also known as “cold ischemia time”) can artifactually render a HER2-positive breast cancer specimen negative on Herceptest® analysis (1)(2)(3). In other words, a particular test could be highly specific and sensitive, but would yield a spurious result if the analytes in the specimen of interest were artifactually altered or corrupted. Some preanalytical errors – specimen mislabeling, for example – are clerical others are related to factors that compromise the quality of the specimen and may reduce or even destroy its suitability for certain types of testing. ![]() In short, an incorrect answer from even a single test can have serious consequences for a patient. Flawed results mean flawed medical decision-making. It has been estimated that data from the pathology laboratory comprises as much as 80 percent of the objective, quantitative disease information that exists in a patient’s medical record – and much of this data directly guides patient management. ![]() We strive for precision and validity in all of our analyses so that the data we generate reflects the true biological state of the patient. The testing process is often separated into three familiar phases: preanalytical, analytical, and post-analytical (also known as the interpretative or consultative phase). As a pathologist, I perform analytical tests on patient specimens to make diagnoses.
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