Speaker Profile

Ph.D., Infectious Disease NGS Dx Sequencing POC, Microbiology Devices, Center for Devices (CDRH), US Food and Drug Administration

Dr. Heike Sichtig is a principal investigator (PI) and subject matter expert (SME) in FDA’s Office of In-Vitro Diagnostics and Radiological Health in the Division of Microbiology Devices. She directs, as sole PI, the highly collaborative effort on developing FDA-ARGOS: FDA dAtabase for Regulatory Grade micrObial Sequences. For her exceptional leadership on this project, Dr. Sichtig was awarded the Commissioners’ Special Citation award in 2016. Dr. Sichtig joined the Division of Microbiology Devices in 2012 and is primarily focused on enabling next generation sequencing (NGS) based technologies for clinical diagnostics. Dr. Sichtig leads a multidisciplinary team developing and implementing concepts for validation and evaluation of NGS-based infectious disease diagnostic devices. She obtained a B.S. / M.S. in Computer Science/Statistics from Kean University in 2002 and 2003, respectively, and a Ph.D. in Biomedical Engineering from Binghamton University in 2009. Subsequently, Dr. Sichtig completed postdoctoral training at the University of Florida/Genetics Institute in Gainesville FL in pathogen signatures, transcriptional regulation and epigenetics.


FDA’s Role and Tools for ID-NGS Diagnostics
The presentation will outline studies to evaluate the use of NGS-based devices and showcase the FDA-ARGOS database resource as an aid in infectious disease diagnostics, and to gain a better understanding of potential NGS clinical implementation strategies. The information contained in the presentation concerning possible approaches for validation represents suggested approaches, open for feedback.

Session Abstract – PMWC 2017 Silicon Valley

Session Synopsis: This session will cover the development and validation of clinical next-generation sequencing (NGS) assays for infectious disease diagnosis in precision medicine and highlight the promise, pitfalls, and regulatory / reimbursement issues associated with these emerging tests.

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