LENIMA FIELD DIAGNOSTICS LLC — Department of Health and Human Services STTR Phase I: DESCRIPTION (provided by applicant): Clostridium difficile (CD) is a bacterium causing dia
LENIMA FIELD DIAGNOSTICS LLC — STTR Phase I award from Department of Health and Human Services.
- Amount
- $300,000
- Agency
- Department of Health and Human Services · National Institutes of Health
- Program / Phase
- STTR · Phase I
- Solicitation
- PA10-124
- NAICS
- —
- Place of performance
- PA
- Period
- —
Description
DESCRIPTION (provided by applicant): Clostridium difficile (CD) is a bacterium causing diarrhea and other intestinal problems linked to 14,000 annual deaths in the US. CDI is an antibiotic-associated infection as well as a health-care-associated infection.Current CDI diagnosis relies on CD toxins enzyme immunoassay (EIA) together with antigen (GDH) EIA. Although stool toxin EIA is specific and relatively fast (hours to 1 day), the sensitivity of toxinEIA is only 60%. Nucleic acid amplification test (NAAT)using quantitative real-time polymerase chain reaction (qPCR) or loop-mediated isothermal amplification (LAMP) to detect the toxin gene tcdB or tcdA is sensitive and specific. However, due to the emergence of hypervirulent strains, detecting tcdA or tcdB alone cannot tell the severity of CDI, and is not sufficient to hel physician make informed CDI treatment decisions. The 30-day mortality rate and recurrence rate for CDI caused by hypervirulent strains are higher and are linked to a third toxin, the b