SpectraScience Inc. announced that results from a critical study conducted by Dr. Helmut Neumann, of the University of Elrangen - Nuremberg in Erlangen, Germany were released recently. 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. The company greatly exceeded the diagnostic accuracy threshold established by the ASGE.

It is its belief that these results provide key validation to its WavSTAT Optical Biopsy System.