SBIR-STTR Award

Rapid Comprehensive Identification Of Pneumonia Pathogens
Award last edited on: 9/20/13

Sponsored Program
SBIR
Awarding Agency
NIH : NIAID
Total Award Amount
$262,052
Award Phase
1
Solicitation Topic Code
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Principal Investigator
Richard S Ajioka

Company Information

BioFire Diagnostics Inc (AKA: Idaho Technology Inc~biofire defense LLC)

390 Wakara Way
Salt Lake City, UT 84108
   (801) 736-6354
   info@biofiredx.com
   www.biofiredx.com
Location: Single
Congr. District: 02
County: Salt Lake

Phase I

Contract Number: 1R43AI098201-01
Start Date: 7/15/12    Completed: 6/30/13
Phase I year
2012
Phase I Amount
$262,052
Lower respiratory tract infections (LRTI), including pneumonia, are a significant threat to human health. For example, community-acquired pneumonia and influenza are together the seventh leading cause of death in the United States. There is a wide range of pathogens that can cause pneumonia. Defining the causative organism in pneumonia, however, is complex. Standard culture-based methods are slow and low-yield, therefore testing is often not performed. At the level of the individual patient, lack of an etioloic diagnosis can lead to the empiric and prolonged use of broad-spectrum antibiotics or to lack of effective therapy. At the population level, lack of a pathogen-based diagnosis decreases the ability to: a) accurately assess disease burden, b) evaluate the effects of interventions such as immunization, c) track antimicrobial resistance and d) investigate new therapeutic agents. Diagnosis of pneumonia would be greatly aided by rapid and comprehensive analysis of patient samples. Idaho Technology Inc. (ITI) manufactures rapid diagnostic products based on integrated PCR and detection technologies. The FilmArray platform is a fully-integrated automated system that performs sample preparation and target identification in one hour. The FilmArray, with its ease-of-use, short time-to-result and highly multiplexed pathogen panels is uniquely suited to the evaluation of both viral and bacterial agents of pneumonia. We propose to test two FilmArray panels, targeting respiratory pathogens and sepsis causing bacteria, on samples from patients with suspected pneumonia. Appropriate choice of site for respiratory collection is a complex question that will be addressed through analysis of several clinical sample types from both adult and pediatric patients (Specific Aim 1). The use of quantification may be beneficial in understanding the relative contribution of pathogens when more than one is detected (Specific Aim 2). At the end of this project, we will choose the most informative site and sample type to move forward toward development of a comprehensive diagnostic test with the potential to significantly improve the care of patients with pneumonia.

Public Health Relevance:
Challenges in diagnosing pneumonia include the large number of viruses and bacteria known to cause lower respiratory tract infections and slow and insensitive confirmation by culture. Idaho Technology's FilmArray platform is a fully-integrated automated system that performs sample preparation and identification of viral and bacterial pathogens in one hour. Existing FilmArray panels directed toward respiratory viruses and sepsis- causing bacteria will be modified to develop a comprehensive test to identify pneumonia pathogens.

Public Health Relevance Statement:
Challenges in diagnosing pneumonia include the large number of viruses and bacteria known to cause lower respiratory tract infections and slow and insensitive confirmation by culture. Idaho Technology's FilmArray platform is a fully-integrated automated system that performs sample preparation and identification of viral and bacterial pathogens in one hour. Existing FilmArray panels directed toward respiratory viruses and sepsis- causing bacteria will be modified to develop a comprehensive test to identify pneumonia pathogens.

NIH Spending Category:
Biodefense; Clinical Research; Emerging Infectious Diseases; Hematology; Infectious Diseases; Lung; Pneumonia; Pneumonia & Influenza; Septicemia

Project Terms:
Address; Adult; Antibiotics; antimicrobial; Antimicrobial Resistance; Bacteria; base; Bronchial Tree; burden of illness; Cause of Death; Cessation of life; Child; Childhood; Clinical; clinical care; Collection; commercial application; Communities; Complex; cost; Data; Detection; Development; Diagnosis; Diagnostic; Diagnostic Procedure; Diagnostic tests; Disease; effective therapy; Etiology; Evaluation; Failure (biologic function); Gold; Health; Hour; Human; Idaho; Immunization; improved; Individual; Influenza; innovation; instrument; intervention effect; Laboratories; Laboratory culture; Lead; Lower Respiratory Tract Infection; Lower respiratory tract structure; Methods; Molecular; Morbidity - disease rate; Mortality Vital Statistics; Nasopharynx; novel therapeutics; Organism; Outpatients; pathogen; Pathogen detection; Patient Care; Patients; Pharyngeal structure; Pleural; Pneumonia; Population; Preparation; Quantitative Evaluations; Radiologic Finding; Relative (related person); respiratory; Respiratory System; Respiratory tract structure; respiratory virus; sample collection; Sampling; Sensitivity and Specificity; Sepsis; Severity of illness; Site; Solutions; Specimen; Speed (motion); Sterility; System; technological innovation; Technology; Testing; Therapeutic Agents; Time; United States; Upper respiratory tract; Viral; Virus; Walking

Phase II

Contract Number: ----------
Start Date: 00/00/00    Completed: 00/00/00
Phase II year
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Phase II Amount
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