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Tetracore Inc. Announces the Successful Completion of a Comprehensive Laboratory Validation of the Tetracore BioThreat Alert® Lateral Flow Assay for the Rapid Detection of Ricin by the United States Department of Homeland Security


6/12/2013 8:57:21 AM

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ROCKVILLE, Md., June 11, 2013 /PRNewswire-USNewswire/ -- Tetracore Inc., a biotechnology company, announces the successful completion of an extensive study of its Ricin BioThreat Alert  Lateral Flow Assay (LFA) and BioThreat Alert LFA Reader by the Department of Homeland Security (DHS). Tetracore Ricin BioThreat Alert LFA is designed to deliver quick and accurate results in the field or laboratory at an affordable cost while being easy to use and store.  The results of this study have produced a comprehensively validated rapid assay for the detection of ricin. 

Public safety and health concerns lead DHS to perform a comprehensive laboratory validation study of a commercially available LFA for the rapid detection of ricin. When suspect environmental samples, including unknown white powders, are discovered in the field authorities are tasked to determine if ricin or another biological threat agent is present. The goal of this study was to provide a reliable rapid field test for ricin, to enable better informed decisions by first responders and public health officials. This will provide for better public safety and reduce the economic impact of false alarms.

The study was coordinated by DHS scientists Dr. David Hodge (Program Manager) and Dr. Segaran Pillai (Chief Science and Medical Advisor) in collaboration with HHS CDC, HHS ASPR/BARDA, FDA CFSAN, FDA CDRH, DHS S&T, DHS CBP, DHS OCAO, FBI, USSS and USDA. The Tetracore Ricin BioThreat Alert LFA and Reader were evaluated at five different testing locations: the Centers for Disease Control (CDC), the Food and Drug Administration (FDA) Center for Food Safety and Applied Nutrition (CFSAN), Massachusetts Department of Public Health, Texas Department of State Health Services and the Virginia Division of Consolidated Laboratory Services.  The study consisted of seven phases to thoroughly test each performance aspect of the LFA, including a repeatability study, an inclusivity panel, an informational panel, a lectin panel, a near-neighbor panel, a white powder panel and testing of BioWatch filter extract. The panels utilized in validating this assay were very extensive and provided a highly robust process to ascertain valuable information regarding the performance of the assay.  No other commercial lateral flow assay developed for field screening of ricin has been comprehensively and independently validated until now.

"Tetracore respects our on-going collaboration with DHS and will continue to validate our BioThreat Alert LFA products rigorously, so that public health laboratories and first responders have confidence in screening for biological threats," stated Dr. Tom O'Brien, Vice President of Tetracore, Inc.

About Tetracore, Inc.
Tetracore Inc. is located in the Biotechnology Corridor in Rockville, Maryland. Tetracore was founded in 1998 by former United Nations Special Commission biological weapons inspectors and scientists of the Naval Medical Research Institute in Bethesda, Maryland. Tetracore is a biotechnology company specializing in the development and manufacture of diagnostic assays and devices for the detection of biothreat agents, veterinary and human diseases.  Tetracore offers BioThreat Alert LFAs for many other biothreat agents, such as Anthrax, and is currently participating in validation studies of its other products.

SOURCE Tetracore, Inc.



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