AOAC SPADA Meeting

IN SILICO ANALYSIS & DIAGNOSTICS

Three Key Entry Points

• Development • Regulatory • Post-Market Surveillance

UNCLASSIFIED

20181017_SPADA_In silico Analysis & Dx

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IN SILICO ANALYSIS & DIAGNOSTICS

• Vendors evaluation (or Gov’t designs) o Parallels the research process – identify strong genomic target sequences o Narrows scope of wet lab testing – balance of resources (staff, funds,  schedule) o Depends heavily on the quality & availability of relevant genomic sequences o Supports technology transitions – secondary evaluation and assay selection • Independent Gov’t Review o Enables success probability assessment – Risk mitigation o Generates supporting data w/o access to wet lab • Difficulties o In silico methodologies often use developmental tools – good, but changing o “Dirty data” – inconsistencies in reference data sources; incomplete  sequences or annotation Development

UNCLASSIFIED

20181017_SPADA_In silico Analysis & Dx

6