Clinical trial for multibeam OCT system yields positive top line results
Michelson Diagnostics (Orpington, England) recently completed a multicenter, prospective clinical trial for basal cell carcinoma diagnosis using the company's VivoSight multibeam optical coherence tomography (OCT) system, with positive top line results.
Related: Michelson Diagnostics finalizes data collection in OCT trial for basal cell carcinoma diagnosis
In the study, over 250 patients with clinically suspicious lesions for basal cell carcinoma were scanned at six centers in Germany. In each case, diagnosis using VivoSight was compared with standard clinical diagnosis with and without dermoscopy. All results were verified by biopsy and histological analysis, which is the current gold standard.
Papers by Professor Dr. med. Julia Welzel and Dr. med. Martina Ulrich discussing the results from the clinical study were presented at the American Academy of Dermatology’s 72nd Annual Meeting (AAD) in Denver, CO, on March 25, 2014.
"VivoSight enabled a statistically significant improvement in the specificity and negative predictive value (NPV) of basal cell carcinoma diagnosis over both clinical and dermoscopy on this cohort of challenging pink patches," as concluded by Ulrich in her AAD presentation. She added that because the system treats patients noninvasively, it therefore renders many biopsies unnecessary.
Full results will be published in a peer-reviewed journal later in 2014.
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