You are here

Development of a Peptidomic Rapid Point-of-Care TB Diagnostic

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41AI091049-01
Agency Tracking Number: R41AI091049
Amount: $524,856.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: NIAID
Solicitation Number: PHS2010-2
Solicitation Year: 2010
Award Year: 2010
Award Start Date (Proposal Award Date): N/A
Award End Date (Contract End Date): N/A
Small Business Information
242 E 33RD ST
United States
DUNS: 826051687
HUBZone Owned: No
Woman Owned: Yes
Socially and Economically Disadvantaged: No
Principal Investigator
 (610) 758-3021
Business Contact
Phone: (212) 998-2121
Research Institution
 New York University
NEW YORK, NY 10012-2331
United States

 () -
 Nonprofit College or University

DESCRIPTION (provided by applicant): The goals of this proposal are to devise rapid serological tests that can replace the sputum smear test for the diagnosis of active TB and meets the WHO specifications to replace microscopy in resource-limited countries based on immunodominant peptides from three M. tb cell-wall proteins. Although direct smear microscopy is highly specific, the test is tedious, time-consuming, requires multiple patient visits before diagnosis, and has limited sensitivity. The Company's approach is based on the prior identification of three cell wall proteins of M. tuberculosis (PTRP, PE-PGRS51 and LipC) that are highly immunogenic in TB subjects, but not in individuals with latent TB infection (LTBI). The identified immunodominant epitopes were mapped and combinations of immunodominant peptides derived from these proteins are predicted to detect gt95% of smear positive TB patients. Specifically we plan to devise microplate ELISA assay(s) based on the peptide combinations demonstrating maximum sensitivity and specificity for detection of anti- TB antibodies in sera, and to verify the performance of the assays with a panel of sera from cohorts of TB-negative subjects (Aim #1); to translate the microplate ELISA assay to a lateral flow point-of- care format using the 9 immunodominant individual peptides previously identified (Aim #2); and to identify the best peptide combination(s) to use in a multiplexed lateral flow device to result in maximum sensitivity and specificity. This assay will be validated with large-panels of clinical samples (Aim #3). During Phase 2, we plan to further validate and refine the rapid test with samples from diverse geographic sites and advance commercialization of both the microplate and rapid lateral flow assays. Testing will be performed with both serum and oral fluids samples. This will allow the Company to determine if it is necessary to have region-specific tests or if one combinatorial test is appropriate worldwide. The development of a non-invasive salivary and/or serum diagnostic test for active TB will fill an urgent need in resource-limited areas. PUBLIC HEALTH RELEVANCE: The work proposed will ultimately lead to development of an inexpensive, robust, and rapid diagnostic ELISA test and point-of-care device for active TB infections. No reliable rapid test for TB currently exists and this assay would represent a major advance.

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

US Flag An Official Website of the United States Government