Assay Development Workgroup Q3-2015 Update
The AYD-WG’s focus is a DST for implementation at the microscopy center level or above. The work group also continues to monitor clinical drug trials to determine when and what changes need to be made to current Target Product Profiles (TPP’s) that have been developed. The AYD-WG is coordinating with academic partners, product development partnerships (i.e., FIND) and industry to facilitate the development of commercial in vitro diagnostic assays for TB DSTs that meet the defined target product profile(s). The Workgroup is depending on substantial and frequent interactions with the other CPTR DST Workgroups.
- Create a “living” and curated document of mutations linked to drug resistance that will inform DST design. Align this effort with the ReSeqTB data platform as a clear deliverable.
- Prioritize list of drugs to inform development of nucleic acid assays.
- Discuss alternative technologies that can address resistance to drugs that are not suited for genetic analysis.
- Determine optimal placement of drug resistance diagnostics within health systems in countries.
- Re-examining workgroup goals and deliverables. Co-chairs agreed to concentrate on facilitating the development of next generation sequencing and growth-based phenotypic drug resistance technologies that are more appropriate for lower tier health systems.
- CPTR continues to meet with Knowledge Synthesis on a monthly basis to review ongoing TBDR Database work. C-Path is now using the database for prototyping internally and plans to incorporate the interface into the ReSeqTB Platform.