In July 2016, authors of the Assay Guidance Manual (AGM) ― a free, best-practices online resource devoted to the successful development of robust, early-stage drug discovery assays ― added two new chapters and revised two others. Updated quarterly, the AGM provides step-by-step guidance for high-throughput screening, lead optimization and early phases of regulated drug development projects.
The new chapters are:
- Cellular Thermal Shift Assay (CETSA), in the In Vitro Cell-Based Assays section. The CETSA methodology provides a powerful and unprecedented approach to validate target engagement within the context of a living cell. This information provides guidance for adapting CETSA to a microplate format to support high-throughput screening and structure-activity relationship studies.
- Interferences with Luciferase Reporter Enzymes, in the Assay Artifacts and Interferences section, focuses on artifacts associated with luciferase reporters, which are heavily used in a variety of primary and counter assays for drug discovery. The goal is to provide researchers with help developing and implementing the best possible primary and counter assays for high-throughput screens.
In addition, two chapters have been revised: Early Drug Discovery and Development Guidelines: For Academic Researchers, Collaborators, and Start-up Companies and Cell Viability Assays. The next update is scheduled for October 2016.