Assay Development Workgroup (AYD-WG) Q4-2015 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.
4Q, 2015 Progress:
- The AYD-WG has drafted a target product profile for diagnostic tests that support patient care has been drafted and is undergoing internal review at FIND. This TPP will include 3 components:
- Sample preparation for NGS sequencers.
- Develop a series of quality standards for the sequencing process.
- Test outputs in terms of interpreting the data and presenting it to providers in a useful way.