AOAC INTERNATIONAL is proposing the formation of a funded, multi-year standards development program to be initiated during the 2021 calendar year under the umbrella of our Stakeholder Program on Agent Detection Assays (SPADA) to develop consensus standards and methods for the use and further development of NGS and bioinformatic applications.

Through the present proposal, AOAC seeks to adapt and expand the use of in silico analysis, molecular diagnostics and next generation sequencing applications for high priority unculturable and emerging biothreat pathogens for environmental surveillance. This will require the development of a unique set of consensus performance requirements and requirements that will form the foundation for future method development, provide guidance to detection assay manufacturers, and establish confidence in data obtained through a “one-test” NGS work stream.

To accomplish these objectives, AOAC INTERNATIONAL will integrate its working group process for adopting Standard Method Performance Requirements, SMPRs® with its premier conformity assessment programs, i.e., the Official Methods of Analysis (OMA) Program and the Performance Tested Methods (PTM) Program.  In concert, these two programs will provide well characterized methods – whether propriety or non-proprietary – that perform with a high level of confidence and reproducibility.

To kick-start this effort, we will be holding a “Thought Leader Discussion (TLD)” Session at our upcoming Midyear Meeting, March 17, 2021 from 8:30-10:30 ET. The purpose of this thought leader discussion will be to bring greater awareness to our effort, engage new stakeholders and further define the strategy laid out in the attached proposal. During the TLD, 3-4 brief presentations (with time for discussion in between) will be offered from representatives of several stakeholder communities working in the genomics/whole genome sequencing space. We would welcome your participation.