Kristian Roth

Kristian Roth

Rockville, Maryland


Kristian Roth, Ph.D. is the Branch Chief in the Bacterial Respiratory and Medical Countermeasures Branch FDA/CDRH/OIR/DMD. He received his Ph.D. in analytical chemistry from the University of California Riverside then completed a postdoc at the University of California Santa Barbara. Afterward he moved to the Seattle area to join CombiMatrix, a startup diagnostics company targeting infectious diseases using DNA microarray detection. There, he worked on developing nucleic acid amplification assays for the detection and differentiation of influenza using microarrays. Dr. Roth then moved to the Maryland area to join Meso Scale Discovery developing lab based and POC capable platforms for the detection of influenza antigen, Hepatitis and radiation biodosimetry. In 2011 he started at FDA as a scientific reviewer and was involved in the writing of guidance documents for assay migration and multiplex infectious disease detection then later served as Branch Chief in the Multiplex Bacteriology and Medical Countermeasures branch in the Division of Microbiology (DMD). The branch has been challenged with recent clearances utilizing mass spectrometry identification of clonal isolates, endogenous biomarkers of infection and ever increasing numbers of syndromic infectious disease panels. Dr. Roth has also been a stakeholder in the emergency response to the recent Ebola and Zika outbreaks.


All session by Kristian Roth


Regulatory Challenges and Opportunities in Clinical Metagenomics