MM01: Molecular Methods for Clinical Genetics and Oncology Testing, 4th Edition

CLSI requests nominations for volunteers to serve as members and contributors on a document development committee for a document revision.


CLSI document MM01 will provide information for laboratories on implementing molecular assays for inherited disorders, including both commercially available test systems and complex laboratory-developed tests. Because molecular diagnostics is multidisciplinary in nature, MM01 will provide an overview of the subspecialties with similar technology or performance specification details. In addition, this revision will include clinical applications of genetic identity testing, including monitoring bone marrow transplant engraftment in hematopoietic stem cell transplant, tracing specimen provenance, and detecting specimen contamination. This guideline will also discuss advances in preimplantation diagnostics and prenatal testing, including noninvasive and cell-free DNA diagnostic methods.

This group is looking for volunteers with:

  • Significant experience establishing and managing medical molecular testing
  • Representation from each major molecular diagnostic subspecialty, including:
    • Inherited diseases testing
    • Prenatal genetic testing
    • Clinical applications of identity testing

Additional information on essential job duties and skills and abilities for CLSI committee participants can be viewed here.

Timeline for this project

Week of June 13–18, 2019: First face-to-face meeting (NOTE: This will be a 2-day meeting scheduled during the June Committees Week in Dallas, Texas.)
June 2019 to November 2020: Drafting of document (higher-intensity volunteer time period) 
February 2021 to April 2021: Voting period for draft document
May 2021 to July 2021: Revision of draft based on comments received during voting
December 2021: Expected publication date

Due date for submission of required documentation

Please submit nominations and required documentation (see Requirements for Nomination Consideration) on or before February 28, 2019 to