Join us in celebrating our 50th Anniversary!
Join us in celebrating our 50th Anniversary!

MM09: Human Genetic and Genomic Testing Using Traditional and High-Throughput Nucleic Acid Sequencing Methods, 3rd Edition

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


CLSI document MM09 will provide guidance for laboratories and industry to implement current best practices and standardized procedures in next-generation sequencing (NGS) test development and validation. The guidance provided in MM09 will also help expedite the development and implementation of quality NGS tests for laboratories and ensure the accuracy and reliability of results. In addition, MM09 will assist in harmonizing US-focused best practices with global standards by providing guidelines that international regulatory organizations can recognize and follow.

This group is looking for volunteers with:

  • Experience in and knowledge about the design and development of NGS tests for human genetic and genomic clinical applications
  • Experience in and knowledge about validation and verification of NGS tests for human genetic and genomic clinical applications
  • Experience with bioinformatics analysis of NGS test results for human genetic and genomic clinical applications
  • Knowledge about interpretation and reporting of NGS test results
  • Knowledge of similarities and differences between targeted whole exome sequencing (WES) and whole genome sequencing (WGS) tests
  • Experience with somatic or germline NGS applications or liquid biopsy applications and knowledge of the similarities and differences among them

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

Timeline for this project

Week of May 31 to June 5, 2018: First face-to-face meeting (NOTE: This will be a 2-day meeting scheduled during the June Committees Week in San Diego, California.)
June 2018 to November 2019: Drafting of document (higher-intensity volunteer time period)
February 2020 to April 2020: Voting period for draft document
May 2020 to July 2020: Revision of draft based on comments received during voting
December 2020: Expected publication date

Due date for submission of required documentation

Please submit nominations and required documentation (see Requirements for Nomination Consideration) on or before March 31, 2018 to