CLSI Publishes New Guidelines on Establishing Molecular Testing in Clinical Laboratory Environments

The Clinical and Laboratory Standards Institute (CLSI) recently published Establishing Molecular Testing in Clinical Laboratory Environments; Approved Guideline (MM19-A), which provides comprehensive guidance for planning and implementation of molecular diagnostic testing, including strategic planning, regulatory requirements, implementation, quality management, and special considerations for the subspecialties of molecular genetics, infectious diseases, oncology, and pharmacogenetics.  

“Molecular diagnostics is the center of a wave that is transforming laboratory medicine, and the healthcare industry is a key enabler of personalized medicine. Removal of technical obstacles is driving some molecular technologies into routine clinical environments,” said Jean Amos Wilson, Ph.D., of Berkeley HeartLab, Inc., Alameda, Calif., and co-chair of the committee that developed the document. “MM19 provides a framework for a routine clinical laboratory that does not have the expertise to create its own assays to incorporate certain molecular testing into its menu by providing tools for strategic planning, safety and facility requirements, and workflows for verification/validation and test launch.”  

The target audience of this guideline is the stakeholders who play a role in the strategic decision to implement a molecular diagnostic program, including the medical and technical directors who may not have previous experience with molecular testing; the supervisory technical staff who implement molecular assays for the first time; quality management systems (QMS) groups who will adapt the quality plan to incorporate the unique aspects of the new program; and the production staff who will perform and maintain all aspects of the assays.

Based in Wayne, Pa., CLSI is a membership-supported, nonprofit organization dedicated to developing standards and guidelines for the healt care and medical testing community through a consensus process that balances the perspectives of industry, government, and the healthcare professions.