Rapid Comprehensive Identification of Pneumonia Pathogens

Period of Performance: 07/15/2012 - 06/30/2013


Phase 1 SBIR

Recipient Firm

Biofire Diagnostics, Inc.
Salt Lake City, UT 84108
Principal Investigator


DESCRIPTION (provided by applicant): 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.