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Sample Processing Cartridges for Rapid PCR TB Detection

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 2R42AI052523-02
Agency Tracking Number: AI052523
Amount: $3,983,527.00
Phase: Phase II
Program: STTR
Solicitation Topic Code: N/A
Solicitation Number: N/A
Solicitation Year: N/A
Award Year: 2006
Award Start Date (Proposal Award Date): N/A
Award End Date (Contract End Date): N/A
Small Business Information
United States
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (973) 972-2179
Business Contact
Phone: (408) 400-8454
Research Institution

DESCRIPTION (provided by applicant): Cepheid Inc and the New Jersey Medical School have developed an assay system that integrates sample processing and real-time PCR diagnosis into a single, hands free process. During the successful completion of a phase I STTR application we demonstrated that this system simultaneously detect the presence of Mycobacterium tuberculosis (TB) and diagnose rifampin resistance directly from clinical sputum samples. The assay uses an inexpensive plastic cartridge to collect sputum samples, concentrate the bacteria present in the sputum, perform high efficiency cell lysis and deliver inhibitor-free DNA into a PCR tube without user input. Detection of TB and rifampin resistance is also performed within the cartridge using a real-time PCR assay and a series of molecular beacon probes. The goal of this phase II STTR application is to further refine the sensitivity and robustness of the assay and to develop the commercial reagents, materials, software and protocols so that our system can be tested in larger-scale trials leading to its commercialization. This STTR will result in a desktop system that is sufficiently simple and robust to be performed anywhere with minimal training; and sufficiently sensitive and specific to be performed on patients with smear negative tuberculosis. Specifically we aim to: 1) Modify the assay to function in a new six-color instrument, and further refine the assay using innovative strategies to increase its sensitivity, specificity and robustness. 2) Convert assay components and protocols into the appropriate format for clinical trials and subsequent commercialization by lyophilizing all reagents for factory packaging, and developing simple methods to load samples and buffers into the cartridge. 3) Perform pre clinical testing to verify assay sensitivity, specificity and limits of detection and assess the effects of potential interfering substances. The system will then be retested using a large number of clinical sputum specimens. Finally, we will develop complete documentation on the assay including production, and development reports.

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

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