SpectraScience, a medical device company that makes light-based analysis systems capable of determining whether tissue is normal, pre-cancerous, or cancerous without physically removing tissue from the body, reports recently released results from a critical study conducted by Dr. Helmut Neumann, of the University of Elrangen – Nuremberg in Erlangen, Germany.
The study was designed to evaluate the potential of the company’s newly introduced WavSTAT4 Optical Biopsy System to predict colorectal lesion histology during screening colonoscopy for colorectal cancer. Scientists used the WavSTAT4 Optical Biopsy system to evaluate 122 colorectal polyps and lesions, which were then removed for further pathological evaluation.
Study results show that roughly 20 percent of lesions were adenomatous, or benign. The WavSTAT4 was able to predict adenomatous histology with a sensitivity, specificity, and accuracy of 81 percent, 84 percent, and 83 percent, respectively. Positive and negative predictive values of WavSTAT4 for in vivo diagnosis of adenomatous tissue were 50 percent and 96 percent, respectively.
In conclusion, Dr. Neumann’s data shows that the WavSTAT4 Optical Biopsy System diagnostic tool enables the real-time prediction of adenomatous colorectal tissue within one second, demonstrating a high Negative Predictive Value (NPV). SpectraScience points out that in accordance with the American Society of Gastrointestinal Endoscopy PIVI statement, this technique has the potential to reduce costs and risks associated with unnecessary physical biopsies.
“We are extremely pleased with the positive results from Dr. Neumann’s study. We greatly exceeded the diagnostic accuracy threshold established by the ASGE,” SpectraScience CEO Mike Oliver stated in the press release. “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.”
For more information visit www.spectrascience.com
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