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Identification of Patients with Clostridium Difficile Infection, Colonization and/or Reoccurrence

Award Information
Agency: Department of Health and Human Services
Branch: Centers for Disease Control and Prevention
Contract: 200-2014-M-60929
Agency Tracking Number: 200-2014-M-60929
Amount: $150,000.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: N/A
Solicitation Number: N/A
Solicitation Year: N/A
Award Year: 2014
Award Start Date (Proposal Award Date): 2014-09-01
Award End Date (Contract End Date): 2015-02-28
Small Business Information
401 E. State Street Suite 200
Ithaca, AK 14850-
United States
DUNS: 022552900
HUBZone Owned: Unavailable
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 Richard  Baldwin
 (607) 272-0002
Business Contact
 Richard  Baldwin
Phone: (607) 272-0002
Research Institution

Clostridium difficile infection (CDI) results in excess of 14,000 deaths and over $1 billion in excess healthcare costs annually. Early and reliable diagnosis is key for both improving treatment outcomes, and instituting precautions to prevent transmission. Antibiotic therapy can actually increase the odds of coming down with a hospital-acquired infection, especially when the cause is a bacterium named Clostridium difficile. Currently there are no serologic assays for C. difficile toxins A and B. Such an assay would be advantageous for defining the epidemiology of CDI and selecting patients in whom to target future vaccines. The ideal serologic assay for CDI would measure circulating IgG and IgA antibodies to C. difficile toxin A and B as well as detect early and specific immunologic responses to these toxins. Agave BioSystems proposed to develop microsphere-based diagnostic assays to meet these objectives and to further develop the microsphere-based assay such that a single blood sample in a single well can detect toxin antibodies and early immunogenic responses to these toxins. These C. difficile microsphere assays will be developed sufficiently enough to differentiate patients that are susceptible for primary infection (asymptomatic), positive for colonization only and those that are likely to have CDI recurrence.

* Information listed above is at the time of submission. *

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