SPADA Meeting Book

7.2.2 The 510(k) Program

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7.2.3 De Novo Classification Process 7.2.4 Premarket Approval (PMA)

8.0 Glossary

9.0 Acknowledgements

10.0 References

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1.0 Abstract/Objective: 27 In this document, we describe use of in silico approaches to improve molecular assay 28 development process and reduce the time and cost by utilizing available databases of whole 29 genome pathogen sequences combined with modern bioinformatics and physical modeling tools. 30 Well defined and well characterized assays are needed for accurately detecting pathogens in 31 environmental and patient samples and also for evaluation of the efficacy of a medical 32 countermeasure that may be administered to patients. The polymerase chain reaction (PCR) 33 remains the gold standard for pathogen detection due to the simplicity of its instrumentation, low 34 cost of reagents, and outstanding limit of detection, sensitivity, and specificity. However, 35 creation of such PCR assays often involves iterations of design, preliminary testing, and 36 thorough validation with clinical isolates and testing in relevant matrices, which can be time 37 consuming, costly, and result in sub-optimal assays. Since formal validation (e.g. for Emergency 38 Use Authorization or Food and Drug Administration licensure) of an infectious disease assay is 39 estimated to cost at least 1 million USD and require 6 months to 12 months, having a well- 40 designed assay upfront is a critical first step. Yet, many assays described in the literature utilized 41 limited design capabilities and many initially promising assays fail the validation process, 42 resulting in increased costs and timelines for successful product development. While the 43 computational approaches outlined in this document by no means obviate the need for wet lab 44 testing, they can reduce the amount of effort wasted on empirical optimization and iterative re- 45

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