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CAP Proposes Improved Oversight of Lab-Developed Tests
Date:9/24/2009

therapy. laboratory performed appropriate validation studies. The test presents low risk to patients. -------------- ------------------- ------------------- --------- Moderate The test result is The laboratory must KRAS Risk often used for submit validation HER2 predicting disease studies to the progression or accreditor for an identifying external review prior whether a patient to offering the test is eligible for a clinically. specific therapy The laboratory may make claims about clinical accuracy or clinical utility. The test has higher risk to patients. -------------- ------------------- ------------------- --------- High The test result The laboratory must Oncotype Risk predicts risk, submit a high-risk Dx(R) progression, test to FDA for review patient prior to offering the eligibility for a test clinically. specific therapy, AND; The test uses proprietary algorithms or computations such that the test result cannot be tied to the methods used; or inter-laboratory comparisons can not be performed. The test poses
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SOURCE College of American Pathologists
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