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Activity Number: 150 - Lead with Statistics in Medical Device Innovations and Beyond
Type: Topic Contributed
Date/Time: Monday, July 30, 2018 : 10:30 AM to 12:20 PM
Sponsor: Section on Medical Devices and Diagnostics
Abstract #330070
Title: Statistics of Counting Molecules for Precision Medicine
Author(s): Svilen Tzonev*
Keywords: single molecule; counting; Poisson; precision medicine; performance characteristics

Current commercially available molecular systems and assays are capable of detecting individual target molecules with considerable reliability. As research and diagnostic tests are developed, validated and deployed for use on clinical samples, the need to understand and develop robust statistical analysis routines increases. This talk will cover the fundamental processes and limitations of detecting and reporting at single molecule resolution. It will cover the basics of quantification of targets and sources of imprecision. It will describe the test performance characteristics in the context of counting statistics. It will provide basic guidelines how to determine those, how to choose and interpret the operating point and what factors may influence overall test performance in practice.

Authors who are presenting talks have a * after their name.

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