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.
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