Novel and emerging technologies create new opportunities to address clinical needs in low-resource settings (LRS). In Cores 2 and 3, the Center will assess clinical needs in LRS and match them with emerging technologies and appropriate biomarkers. In Core 1, the center will evaluate early prototype devices for their application as point-of-care (POC) diagnostic tools in LRS. We will select devices to be evaluated under Core 1 activities through a process centered around three main themes: (1) health impact and stakeholder acceptance, (2) relevance of attributes to the needs and realities of LRS, and (3) market issues relevant to LRS. The themes are explained in further detail in Core 2. We expect to select from a variety of sources, such as academic, commercial, and nonprofit research groups identified through a formal solicitation process (described in Core 2); from a database of unsolicited technology disclosures, which PATH regularly receives; and from disclosures from our network of technology transfer offices at universities and other institutions that have agreed to partner with us on the Center grant. Using the findings from the Core 1 clinical evaluation phase, we will* select promising early prototypes for transition to later-stage (beta) prototypes that meet the specifications that justify further largescale clinical testing. For Core 1 projects, we will select prototype diagnostic devices that are expected to achieve some or all of these characteristics: ? Low per-test cost. ? Easy-to-use; minimal training requirements. ? Uses minimally invasive samples. ? Minimal upfront investment in device/reader. ? Minimal maintenance and calibration. ? Applicable to multiple analytical targets that are of interest in developing countries (either platforms capable of multiplexing or single-plexed assay platforms usable for various targets). ? Minimal/no external sample preparation needed. ? Makes use of assay supplies that are stable under elevated temperatures?no refrigeration needed. ? Portable to field locations. The Center will evaluate early prototype devices that fulfill as many of these requirements as possible. These prototypes should also have reached a stage of development at which we can move quickly from initial laboratory-based evaluation to field-based clinical testing with no significant design or manufacturing challenges. Most likely, such devices will be novel platforms with broad applicability, as opposed to novel tests based on existing platforms, although this requirement is not absolute. This clinical evaluation process, performed collaboratively with the diagnostics developers under Core 1, will involve three stages: in-house laboratory evaluation, field evaluation, and report and transition. ? 1: In-house laboratory evaluation Testing of device or technology specifications and performance, stability tests, and preliminary evaluation of training materials will be performed at PATH using PATH'S laboratory and shop capabilities and expertise in diagnostic and medical device development and evaluation. ? 2: Field evaluation Field testing will be carried out at clinical sites emulating final-use conditions. The tests will use clinical samples and appropriate reference standards and methods for comparison. ? 3: Evaluation report and transition The evaluation report will include: results from the in-house laboratory evaluation, results from the field evaluations, and device assessments performed under Core 3. We have allocated a period of time to discuss the evaluation findings with the developers and options for the transition to the next phase of clinical testing. Each diagnostic device will progress through these three stages of evaluation. However, it is anticipated that each device will have its own unique performance criteria and characteristics. The evaluation process will be tailored to fit each device without compromising the integrity or rigorous scrutiny of the evaluation process. If a diagnostic device fails to meet predetermined performance standards at any point during the evaluation, it will be sent back into the iterative research and development loop to address the stated need.

Agency
National Institute of Health (NIH)
Institute
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Type
Specialized Center--Cooperative Agreements (U54)
Project #
1U54EB007949-01
Application #
7509019
Study Section
Special Emphasis Panel (ZEB1-OSR-D (O1))
Project Start
2007-09-30
Project End
2012-06-30
Budget Start
2007-09-30
Budget End
2008-06-30
Support Year
1
Fiscal Year
2007
Total Cost
$405,978
Indirect Cost
Name
Program/Appropriate/Technology/Health
Department
Type
DUNS #
103713624
City
Seattle
State
WA
Country
United States
Zip Code
98121
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