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Optical Biopsy

Organization:Boston University, MA, US
I.P. Brief:The invention is a method and apparatus for determining the nature of tissue (e.g. cancerous or non-cancerous) by placing two or more fiber optic probes in contact with the tissue and performing a spectral analysis of the light that passes through the tissue.
Summary of I.P.:Optical biopsy technology has the promise of performing instantanous, non-invasive diagnosis of cancer. There are many applications for this technology. For example, the optical fibers can be integrated with endoscopy equipment so that physicians could objectively assess a questionable tissue as cancerous, pre-cancerous or benigh during a colonoscopy or other procedure. The technology could also be integrated into a handheld device for instant analysis of moles or other dermatological fetures as an early detection of skin cancer.
Patent:5,894,340; 6,011,626; 6,381,018 plus additional provisionals
Keywords:Biopsy, Optical, Fiber Optic, Elastic Scattering Spectroscopy
Primary Industry:Health & Medical Devices
Specific Market:Cancer Diagnostics
Market Size:There are many verticals. One is colon cancer. There are approximately 85 million people above the age of 50 in the U.S. - approximately 60 million of these people have not yet been screened by endoscopy.
State of the Art:No technolgies exist to provide a localized diagnosis with high specificity and sensitivity without removing tissue and sending it to the laboratory.
Competition:OCT, Fusion Imaging (e.g. PET/CT), Fluroescence (though not as accurate)
Figures of Merit:Each reading takes only a few miliseconds - so it is fast. It is small and can be integrated into existing endoscopy equipment with minor modifications - so it is backwards compatible. Is is very sensitive/specific.
Tech.  Obstacles:Analysis has been performed on many clinical samples. Proof of concept is complete. The next step in technology development is productization and regulatory approvals around efficacy (as opposed to safety).
Market Obstacles:The next step in each market vertical (or tissue type) is to increase the number of clinical tests to improve statistical significance of each measurment. This work is currently underway for certain applications such as colorectal cancer. The increase volume of data will be helpful in convincing phyysicians that these tests are worthwhile, time saving procedures that have strong patient benefits.
Patent Landscape:The fundamental patents are owned by Los Alamos and available for licencse. Application specific patent applications are in process.
Publications:I. J. Bigio, S.G. Bown, G. Briggs, S. Lakhani, D. Pickard, P.M. Ripley, I.G. Rose and C. Saunders \"Diagnosis of breast cancer using elastic-scattering spectroscopy: preliminary clinical results\" Journal of Biomedical Optics 5: 221-228 (2000) Judith R. Mourant, Tamara M. Johnson, Gerrit Los, Irving J. Bigio \"Noninvasive measurement of chemotherapy drug concentrations in tissue: preliminary demonstrations of in vivo measurements\" Journal of Physics in Medicine and Biology 44: 1397-1417 (1999)
Research Team:rving J. Bigio Ph.D. Associate Chair for Graduate Studies, Biomedical Engineering; Professor, Department of Biomedical Engineering; Professor, Department of Electrical and Computer Engineering


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