CLSI MM01-A3 Molecular Methods for Clinical Genetics and Oncology Testing - Approved Guide

This revision of MM01 provides guidelines for laboratory testing practices, methods and technologies for the detection of hereditary and somatic genetic variation. The title of this document has been revised to reflect the wide variety of indications for molecular genetic testing, as not all genetic testing is done for the purpose of disease diagnosis. This standard is intended as a source of reference material for medical genetic testing laboratories performing nucleic acid-based testing.

This standard includes the performance specifications of the total molecular genetics laboratory testing process, namely pre-examination, inspection and post-examination. This standard is intended to provide guidance to experienced laboratory managers, inspectors, and manufacturers involved in test development, validation, and interpretation of molecular genetic testing.

This standard is not intended to be used as an introductory guide for laboratories lacking experience in molecular genetics. In contrast, the performance characteristics of complex, multivariate diagnostic assays that use opaque, mathematical algorithms to interpret genetic risk or probability of drug response are beyond the scope and evaluation of this guide, but are covered in the CLSI document MM17.

EUROLAB assists manufacturers with CLSI MM01-A3 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.