DIATHERIX Laboratories, Inc., has been awarded a second federal contract to continue its work in the development of methodologies for diagnostic tools to detect certain low prevalence, high priority biodefense pathogens.
The contract is a joint award from the Food and Drug Administration (FDA) and the Department of Health and Human Services (HHS). The contract award is for one year.
Diatherix’s research focuses on three NIAID pathogens: Francisella tularensis, Escherichia coli, and Babesia microti. Though not prevalent in the natural environment, the pathogens are prioritized by NIAID because of the ease with which they can be disseminated or transmitted; the mortality rates and public health impact they can generate; their potential to cause public panic and social disruption; and the special actions that are required for public health preparedness.
The low prevalence of these pathogens complicates the development of diagnostic tools to aid in their detection, as sufficient clinical samples may not be available to conduct the clinical sensitivity studies required for FDA clearance.
To address this regulatory and scientific challenge, the FDA is exploring the use of “spiked” clinical samples – special lab samples in which the pathogen being studied is introduced at increased or enriched levels – to support sensitivity studies for the evaluation of diagnostic devices.
Diatherix’s expertise in developing highly sensitive tools used in molecular analysis allows detection of pathogens in ranges as low as 10 organisms per milliliter. The company’s proprietary Target Enriched Multiplex Polymerase Chain Reaction (TEM-PCR) technology will be deployed on spiked clinical samples in this research effort as Diatherix builds on protocols established by a collaborative project between the FDA Center for Biologics Evaluation and Research/Division of Emerging and Transfusion Transmitted Diseases (CBER/DETTD), Center for Devices and Radiological Health/Office of In Vitro Diagnostics (CDRH/OIVD) and NIAID.