Currently, the detection of breast cancer relies upon diagnostic examinations such as screening mammography and magnetic resonance imaging. Suspicious breast lesions must then be subjected to biopsy, using procedures such as fine needle aspiration biopsy (FNAB), core biopsy or surgical excisional biopsy. These procedures provide varying amounts of tissue for subsequent histopathological analysis by light microscopy, augmented with antibody-based immunohistochemical methods for definitive diagnosis. Because nearly 80% of breast biopsies confirm a benign disease process, further technical advances that permit more accurate in situ diagnosis are essential. Such technical improvements could provide cost savings by avoiding needless surgery and would also minimize physical suffering. A method that provided immediate diagnosis at the time of biopsy would also offer the potential for diminished patient anxiety by avoiding the temporal delays between the act of biopsy and final pathological report.

Recently, the ability to characterize biological tissues with Raman spectroscopy has been demonstrated by a number of investigators and is currently a lively area of research. Ciencia is collaborating with clinicians at the University of Pennsylvania and Emory University and scientists at Ohio State University to develop instrumentation and methods for cancer diagnostics based on Raman spectroscopy. Ciencia has recently been funded by The National Cancer Institute to evaluate the efficacy of this method for early detection of breast cancer. In this project we are examining a large number of biopsy samples covering a broad spectrum of disease in order to develop pattern recognition/neural network methods to assess the utility of this approach for clinical diagnostics. Samples are being examined by Raman spectroscopy and then processed through conventional histopathological techniques. Optical biopsy techniques, such as this, offer the extraordinary potential of performing biopsies in vivo with minimally invasive techniques. The method can be extended to many other diseases, such as coronary artery plaque analysis (detection of unstable plaque), colon, bladder and prostate and skin cancers, and many others.