SAN DIEGO, CA--(Marketwired - Jun 11, 2013) - SpectraScience, Inc. (
The main objective of the study was to evaluate the potential of Spectra Science's newly introduced WavSTAT4 Optical Biopsy System for prediction of colorectal lesion histology during screening colonoscopy for colorectal cancer.
The system consists of a console (comprised of a light source, spectrophotometer and algorithm) and the Optical Biopsy Forceps (OBF). The OBF consists of a standard biopsy forceps in which an optical fiber is integrated. Once a diminutive lesion is detected, the OBF is advanced through the working channel of the endoscope and the optical fiber placed in contact with the tissue to be biopsied. After pushing a foot pedal the system determined within one second if the lesion is adenomatous or not. In the study, colorectal polyps and lesions were evaluated with the WavSTAT4 Optical Biopsy System and afterwards removed for subsequent pathological evaluation.
Overall, 122 colorectal lesions were evaluated with the system. About 20% of lesions were adenomatous. The WavSTAT4 could predict adenomatous histology with a sensitivity, specificity and accuracy of 81%, 84%, and 83%, respectively. Positive and negative predictive values of WavSTAT4 for in vivo diagnosis of adenomatous tissue were 50% and 96%, respectively.
Dr. Neumann's study concluded that the WavSTAT4 Optical Biopsy System is a new diagnostic tool which allows the real-time prediction of adenomatous colorectal tissue within only one second and shows a high Negative Predictive Value (NPV). In accordance with the American Society of Gastrointestinal Endoscopy PIVI statement, this new technique has the potential to reduce costs and risks associated with taking unnecessary physical biopsies.
SpectraScience CEO Mike Oliver commented, "We are extremely pleased with the positive results from Dr. Neumann's study. We greatly exceeded the diagnostic accuracy threshold established by the ASGE. It is our belief that these results provide key validation to our WavSTAT Optical Biopsy System. We are hopeful that the demonstration of clinical efficacy along with the WavSTAT4's ease of use and cost effectiveness will lead to the increased use by gastroenterologists and nurse endoscopists all over the world."
About SpectraScience, Inc.
SpectraScience is a San Diego based medical device company that designs, develops, manufactures and markets light-based analysis systems capable of determining whether tissue is normal, pre-cancerous or cancerous without physically removing tissue from the body. The WavSTAT Optical Biopsy System uses light to optically diagnose tissue and provide the physician with an immediate analysis. With approval for sale under the CE Mark for the European Union, the WavSTAT System is the first commercially available product that incorporates this innovative technology for clinical use.
- Helmut Neumann
Chief Financial Officer