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  5. FDA Grand Rounds: Detection of Transmissible Spongiform Encephalopathy Agents in Biological Products Using Protein Aggregation Assays - 02/13/2020 - 02/13/2020
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Webcast | Virtual

Event Title
FDA Grand Rounds: Detection of Transmissible Spongiform Encephalopathy Agents in Biological Products Using Protein Aggregation Assays
February 13, 2020

February 13, 2020

About the Presentation:

Transmissible spongiform encephalopathies (“TSEs” or “prion diseases”) are rare, fatal illnesses that are transmitted by contaminated biologics such as tissues and blood products, surgical instruments and certain drugs (hormones) derived from human pituitary glands. Of particular interest to the CBER Lab of Bacterial & Transmissible Spongiform Encephalopathy Agents LBTSEA) is Creutzfeldt-Jakob disease (vCJD), a human TSE transmitted by blood transfusions and plasma products.

All TSEs have long asymptomatic incubation periods. During this phase, the host appears healthy and can donate infected blood or tissues without detection. Although vCJD is very rare, its impact is devastating as there is no vaccine or cure. New, rapid tests for TSE diseases are needed to improve the safety of blood and tissue donations and to possibly screen those biologicals that are at risk of being contaminated with the TSE agent.

In this presentation, the speaker will describe the results detecting vCJD agent in blood of macaques experimentally infected with the vCJD agent, using an in vitro test called “protein misfolding cyclic amplification” (PMCA). The macaque blood panels cab be used to help assay developers validate candidate blood screening tests. An alternative in vitro method,“real-time quaking-induced conversion” (RT-QuIC), used to detect TSE agent in biological materials other than blood will also be discussed.

About the Speaker(s):

Luisa Gregori, PhD
Chemist and Principal Investigator
Lab of Bacterial & Transmissible Spongiform Encephalopathy Agents, Division of Emerging and Transfusion Transmitted Diseases (DETTD), CBER


Dr. Luisa Gregori received her PhD in Chemistry in Italy and completed postdoctoral training at the University of Florida in Gainesville, Florida. She joined FDA in 2008 as principal investigator in the laboratory of Bacterial and Transmissible Spongiform Encephalopathy (TSE) Agents, in the Office of Blood Research and Review. Before joining FDA, she was deputy director of the laboratory of neurovirology at the VA Medical Center in Baltimore and assistant professor in the Department of Neurology, School of Medicine at the University of Maryland.

She has more than 20 years of experience in TSE or prion research. Specifically, her research focuses on detection and removal of TSE agents in blood and other biologicals using biochemical methods of detection and animal bioassays.


Archived recording of this webcast.

For technical assistance please contact devin.thomas@fda.hhs.gov.

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