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FDA, HHS Awards Diatherix Contract for PCR-based Pathogen Detection Methods

NEW YORK (GenomeWeb) — The US Food and Drug Administration and the US Department of Health and Human Services have awarded Diatherix Laboratories a one-year federal contract to continue developing research methodologies for detecting low-prevalence pathogens, the company said. 

It is the second federal contract awarded to the firm for work in this area and will support Diatherix's development of technologies directed at Francisella tularensis, Escherichia coli, and Babesia microti. Though the pathogens are not prevalent in the natural environment, they are prioritized by the National Institute of Allergy and Infectious Diseases because they can be easily transmitted and disseminated; can have high mortality rates; have the potential to create public panic and social disruption; and require special public health preparedness, the Huntsville, Ala.-based firm said. 

Because of the low prevalence of the pathogens, the FDA is investigating the use of spiked clinical samples in order to circumvent the lack of available clinical samples needed to conduct clinical sensitivity studies for FDA clearance. As part of its work under the contract, Diatherix will use its target enriched multiplex PCR technology on spiked samples as it builds on protocols established by the FDA Center for Biologics Evaluation and Research/Division of Emerging and Transfusion Transmitted Diseases, the Center for Devices and Radiological Health/Office of In Vitro Diagnostics, and NIAID. 

Financial terms of the contract were not disclosed.