AOAC SPADA Meeting

3/11/2020

TABLE OF CONTENTS

• Outline of talk

• Background and Rationale • Assay Development Process: Traditional vs modern • Assay Design • Metrology for In Silico Analysis • Assay Development and Characterization • Regulatory Considerations for Nucleic Acid-based Clinical Assays • Glossary

AOAC_SPADA_ISA_presentation

3/12/2020

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AVAILABILITY OF WHOLE GENOME SEQUENCES VS. ASSAY DESIGN TIME FRAME

 Databases are growing exponentially  We should use

this information in a modern design pipeline.

AOAC_SPADA_ISA_presentation

3/12/2020

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