Respiratory Panel Flow-Strip: a Point-of-Care Molecular Diagnostic Test

Award Information
Agency: Department of Health and Human Services
Branch: N/A
Contract: 1R43AI096592-01A1
Agency Tracking Number: R43AI096592
Amount: $300,000.00
Phase: Phase I
Program: SBIR
Awards Year: 2012
Solicitation Year: 2012
Solicitation Topic Code: NIAID
Solicitation Number: PA11-096
Small Business Information
400 Sagner Avenue, Suite 300, FREDERICK, MD, 21701-6082
DUNS: 154704444
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 (301) 698-0101
Business Contact
Phone: (301) 698-0101
Research Institution
DESCRIPTION (provided by applicant): Acute respiratory infections are the third leading cause of death worldwide, and account for 4.2 million deaths annually; more than 40% are children under five. Conventional techniques are often either too slow (e.g.,conventional cultures require 5 to 10 days) or too insensitive (e.g., one study found the sensitivity of a laterl flow immunoassay test for flu to be as low as 10.4%). Despite their insensitivity, the lateral flow test market for infectious disease grew over 40% in 2009. Because of its sensitivity and specificity, molecular testing are beginning to supplant conventional culture as the gold standard. However, limitations with current molecular tests for identifying multiple respiratory pathogens from a single sample include: high complexity operation, lack of sensitivity, lack of respiratory pathogen coverage, and/or lack of sequence coverage for a given pathogen. Thus, we propose to address these limitations with an automated sample-to-answer point-of- caremolecular device that identifies hypervariable genomes across the following panel of respiratory pathogens: influenza A virus, influenza B virus, human respiratory syncytial virus A/B, human adenovirus A/B/C/D/E/F, human coronavirus 229E/NL63/OC43, metapneumovirus, human rhinovirus A/B/C, human bocavirus 1/2/3/4, human parainfluenza virus 1/2/3/4, Haemophilus influenzae, Streptococcus pneumoniae, Mycoplasma pneumoniae, Chlamydophila pneumoniae, Legionella pneumophila, and Bordetella pertussis. PUBLIC HEALTH RELEVANCE: Acute respiratory infections are the third leading cause of death worldwide, and account for 4.2 million deaths annually; more than 40% are children under five. The pathogens that cause these infections often are highly contagious, and infect susceptible individuals before tests can be commercialized. This project seeks to develop a point-of-care test that identifies a panel of bacteria and viruses, including drug-resistant strain of flu, from a single patient sample. This test could assist in the preparedness for global pandemics because of the ongoing availability of a test that can identify a broad panel of contagious respiratory pathogens. This strategy has the potential to eliminate the burden of having to quickly develop and commercialize single-organism tests in response to an emerging pandemic.

* information listed above is at the time of submission.

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