Clinical and Laboratory Standards Institute document MM01-A3 – Molecular Methods for Clinical Genetics and Oncology Testing; Approved Guideline – Third Edition provides general recommendations for all phases of the operation of a molecular genetics diagnostic laboratory. Clinical molecular testing has application to inherited and acquired medical conditions with genetic etiologies as well as variations associated with drug metabolism. In a clinical molecular laboratory, techniques and practices require strict adherence to quality performance measures. This revised guideline will address the total testing process.
CLSI MM01-A3
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Molecular Methods for Clinical Genetics and Oncology Testing; Approved Guideline-Third Edition, MM01A3E
Clinical and Laboratory Standards Institute , 05/01/2012