Diatherix Nabs Second Joint HHS-FDA Contract
The FDA and Department of Health and Human Services have awarded a one-year joint contract to Diatherix Laboratories so that it can continue developing diagnostics to detect three low prevalence pathogens that have been deemed high priority by the National Institute of Allergy and Infectious Diseases.
The pathogens — Francisella tularensis, Escherichia coli and Babesia microti — are rarely found in nature, but are easily spread and can cause illness and death. F. tularensis, for instance, is highly infectious in very small doses and can be spread using an aerosol can. The Department of Homeland Security has classified it a Category A pathogen/biological agent, meaning it poses a high risk to national security and public health.
Due to their rarity, however, it can be hard to find clinical samples to conduct sensitivity studies, Diatherix said, adding the FDA is considering allowing “spiked” samples that have enriched levels of the pathogen to evaluate the diagnostics. The spiked samples will be tested using the company’s target-enriched multiplex polymerase chain reaction technology. — Kellen Owings
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