SBIR-STTR Award

The development of new technologies for the rapid and accurate detection of indicators of diseases such as cancer will have a significant impact on human health. Current diagnostics are performed in highly sophisticated clinical laboratories, which requires significant overhead investment in instrumentation and highly trained medical technology staff. Furthermore, most tests are time consuming and the waiting period causes significant anxiety in patients. This project will develop a real-time, nanowire optical assay probing system for the detection of disease indicators. The technology will be portable, accurate, cost effective, and easy to use. It will simplify medical diagnostics in the doctor’s office, making results available immediately, and provide a means of testing where clinical laboratory work is not an option (e.g., first responders or medical workers in third world countries). P hase I will demonstrate that a novel probe comprised of bio-chemically functionalized nanowire arrays can be utilized for highly sensitive detection of disease indicators using optical analysis techniques. To show proof-of-principle, the probe will be used to detect a protein indicative of ovarian cancer, CA 125. In P hase II, the range of analytes will be expanded and the nanowire probe will be integrated with the optical and electronic sub-assemblies required to develop a commercially viable, hand-held, highly sensitive, fully functional medical diagnostic instrument.

Commercial Applications and Other Benefits as described by the awardee:
The current commercial market for in vitro medical diagnostics is $38 billion/year. The technology would replace hundreds of assays in the clinical and research laboratory with a hand-held, instrument that provides an instant readout of results. The versatility of this technology would make it applicable to the detection of a broad range of human health indicators including: infectious diseases, autoimmune diseases, tumor markers, thyroid function, fertility markers, allergy and humoral immunity, cardiac markers, hormone levels, therapeutic drug monitoring, and toxicology/drugs of abuse. Further, the technology could be adapted for the early and accurate detection of chemical and biological weapons and for environmental monitoring of pollution in water or air and contaminants in food

More sensitive detection methods leading to early diagnosis could significantly impact the treatment of cancer and other diseases and dramatically increase survival rates. However, current methods used to detect disease indicators do not have the needed sensitivity and often are effective only once the indicator concentration has reached a critical level. Nanotechnology-enabled probes, which can interact with and sense biological compounds on the molecular level, hold great promise for point-of-care diagnosis of disease. This project will develop a nanowire optical probe that uses surface enhanced Raman scattering (SERS) as a method for molecular identification. The probe will be incorporated into a portable, rapid, and highly sensitive assay system that will detect multiple biomedical substances in patients. In Phase I, a nanowire optical probing platform was successfully engineered. Antibodies for the ovarian cancer marker CA 125 were used to characterize the sensor platform as to its optical, chemical, and biological properties. Phase II will expand the development of the nanowire optical assay probe, integrate the probe with diagnostic control systems, and perform clinical laboratory tests to compare the nanowire assay performance with standard clinical laboratory assays. Finally, a prototype diagnostic instrument will be produced.

Commercial Applications and Other Benefits as described by the awardee:
The nanowire assay probe should be able to identify virtually any antibody, offering the potential to replace hundreds of assays in clinical and research laboratories with a portable instrument. In addition, the probe could have a significant impact on world health because the system could be used with very little infrastructure requirements. Lastly, these probes could be configured to detect chemical and biological compounds in the environment, lending them valuable in the detection of chemical and biological weapons for homeland security.