Characterization of Respiratory Pathogens in Transplant Patients

Award Information
Agency:
Department of Health and Human Services
Branch
n/a
Amount:
$126,975.00
Award Year:
2009
Program:
SBIR
Phase:
Phase I
Contract:
1R43AI082843-01
Award Id:
93417
Agency Tracking Number:
AI082843
Solicitation Year:
n/a
Solicitation Topic Code:
n/a
Solicitation Number:
n/a
Small Business Information
IDAHO TECHNOLOGY, 390 WAKARA WAY, SALT LAKE CITY, UT, 84108
Hubzone Owned:
N
Minority Owned:
N
Woman Owned:
N
Duns:
556915205
Principal Investigator:
MARK PORITZ
(801) 736-6354
MARK_PORITZ@IDAHOTECH.COM
Business Contact:
KIRK RIRIE
() -
contracts@idahotech.com
Research Institute:
n/a
Abstract
DESCRIPTION (provided by applicant): Immunocompromised patients including those who have undergone hematopoietic stem cell (HSCT) and solid organ (SOT) transplants are at markedly increased risk for severe disease caused by respiratory pathogens. These pat ients have greater susceptibility to a broader range of organisms and frequently present with more advanced disease. In addition, they often have higher organism burden and are infected with multiple pathogens either as primary infectious agents or as a se condary infectious complication. Moreover, because of an impaired host immunologic response to infectious agents, immune based diagnostic strategies such as serology can be unreliable. While molecular assays offer the advantage of improved sensitivity and specificity, most testing of respiratory samples is done by singleplex PCR that are performed by send-out specialty laboratories and take several days or more before results are available. The lack of rapid diagnostic testing for a wide range of respirator y pathogens often results in a delay in initiation of targeted anti-microbial therapies, which can result in increased morbidity and mortality. Indeed, transplant and immunocompromised patients provide a significant diagnostic challenge and a great unmet c linical need. The goal of this Phase I SBIR study is to test 300 respiratory samples from adult HSCT/SOT patients followed at Brigham and Women's Hospital/Dana-Farber Cancer Institute using a multiplex PCR (FilmArray RP) system that features the real-time capacity of detecting 22 respiratory pathogens within one hour. Specifically, we will compare the diagnostic performance of the FilmArray RP system to currently used CLIA approved clinical diagnostic assays for respiratory pathogens in transplant patients, both HSCT and SOT, sampled by nasopharyngeal aspirate (NPA) and by bronchoalveolar lavage (BAL). We anticipate that the results from this Phase I study will lead to an innovative Phase II study where a multiplex PCR pouch designed to detect an expanded pa nel of respiratory pathogens will be tested. The successful testing of the FilmArray RP system could ultimately lead to improved management of this immunocompromised patient population and potentially lead to an overall deceased cost in health care deliver y. PUBLIC HEALTH RELEVANCE: Undiagnosed respiratory pathogens are a major problem for organ transplant patients because their immune systems are often not fully functional. Idaho Technology Incorporated has developed a diagnostic system (termed FilmArray) that can rapidly (lt1 hour) detect a large number of respiratory pathogens with minimal operator effort. We will test the idea that FilmArray can aid in the diagnosis of respiratory symptoms in transplant patients and thus lead to improved treatment.

* information listed above is at the time of submission.

Agency Micro-sites


SBA logo

Department of Agriculture logo

Department of Commerce logo

Department of Defense logo

Department of Education logo

Department of Energy logo

Department of Health and Human Services logo

Department of Homeland Security logo

Department of Transportation logo

Enviromental Protection Agency logo

National Aeronautics and Space Administration logo

National Science Foundation logo
US Flag An Official Website of the United States Government