SBIR/STTR Research Award
Rapid, Accurate, and Low-Cost Stool Clostridium difficile Genetic Test
Award amount
$300,000Program and phase
STTR · Phase IAward year
2014Award details
- Awarding agency
- Department of Health and Human Services
- Branch
- National Institutes of Health
- Recipient company
- LENIMA FIELD DIAGNOSTICS LLC
- Proposal award date
- Not reported
- Contract end date
- Not reported
- UEI
- HZ4BH65BD8S3
- Solicitation number
- PA10-124
- Topic code
- NIAID
Research abstract
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
Technology keywords
Not reported
Other awards by this recipient
Verified by the same UEI. These are other public SBIR/STTR award pages, not a merged company record.
- Instant Antimicrobial Susceptibility Test
- A Low-Cost Portable Multiplex Serum Molecular Test for HBV and HCV Detection
Awards with the same topic code
Verified by an exact topic code match. This is not a text-similarity match.
- Manufacturing and Formulation Process Development for a Prophylactic Cholera Phage Cocktail
- A first-in-class product for the clearance of high-risk human papillomaviruses
- A Rapid, Point-of-Care Diagnostic to Identify Viable Sexually Transmitted Infections, Reduce Overtreatment, and Prevent Emerging Antibiotic Resistance
- Optimization, Pharmacokinetics, and Efficacy of an IgG Protease for the Treatment of Immune Thrombocytopenia and Other IgG-Mediated Autoimmune Diseases
- Nebulized ALX1 as a treatment for Pseudomonas aeruginosa infections in bronchiectasis patients
Research funding history
3 SBIR/STTR records share this UEI (2014–2020). Reported award amounts total $852,128. Reported amounts are not federal obligations.
Phases: Phase I
Agencies: Department of Health and Human Services