Point of care (POC) testing (also referred to as near patient, bed side, or extra laboratory testing) can result in improved clinical outcomes in medical care. These improvements include faster decision making, earlier start of treatment, improved adherence to treatment, reduced incidence of complications, more rapid optimization of treatment, reduced hospital readmission rate, and better patient satisfaction. Additional operational and economic benefits can also accrue. These potential benefits have created a growing market for POC tests that can aid in the diagnosis and treatment of a wide variety of medical diseases and conditions. To achieve effective and accurate POC testing, the assay methodology must be easy to use, provide accurate answers, provide results on a time scale, require handheld or small bench top instrumentation, and require minimal training of assay performers. A limitation to the methodologies currently seeking to meet the needs of POC testing is the cost and complexity of the instruments used, and the training required to correctly perform the assay procedures. To overcome this limitation, Intelligent Optical Systems proposes to extend a simple label- free clinical assay system to a wide range of POC applications, and to later use this same technology to address high throughput screening applications. The estradiol assay developed in Phase I work, which is based on the observation of localized surface plasmon resonance (LSPR) on an array of Ag nanoplates, will be extended to the development of a clinical assay panel for the early diagnosis of ovarian cancer. These panels will simultaneously assay several indicators used for the prognosis of breast cancer, and for fertility treatment. These are medically significant, commercially attractive applications that will allow the basic LSPR assay system to be developed into a commercial product. Designs will be developed for assay chemistries, disposable assay substrates, and a handheld instrument for operation of all assays. The commercialization of these products is expected to lead to further expansions of the assay technology, and as a platform for a wide range of POC testing. The assay system will also be expanded to address high throughput screening applications. Considerable savings in the time and cost of both types of assays is anticipated.

Public Health Relevance

It is now possible to perform many clinical medical tests in a short period of time at the location where patient care is being given. Many medical benefits can be gained from such rapid testing. The proposed simple point of care clinical assay system has the potential of making more tests available to more patients at a lower cost. ? ? ?

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
Project #
2R44CA108017-02A1
Application #
7482168
Study Section
Special Emphasis Panel (ZRG1-EMNR-E (11))
Program Officer
Rahbar, Amir M
Project Start
2004-03-01
Project End
2010-08-31
Budget Start
2008-09-01
Budget End
2009-08-31
Support Year
2
Fiscal Year
2008
Total Cost
$493,243
Indirect Cost
Name
Intelligent Optical Systems, Inc.
Department
Type
DUNS #
033449757
City
Torrance
State
CA
Country
United States
Zip Code
90505