Michelson Diagnostics (Orpington, England), which specializes in multibeam optical coherence tomography (OCT) technology, has completed scanning and data collection for a 250-patient, multicenter clinical trial testing diagnostic performance of the company's VivoSight OCT scanner in diagnosing superficial basal cell carcinoma (BCC), the most common form of skin cancer.
The study compares how well dermatologists were able to diagnose BCC using the scanner against skin biopsy with histopathology and visual examination with a dermatoscope, which is the current gold standard. Conducted at six dermatology centers in Germany, the study is the first diagnostic study of OCT in dermatology that is designed to generate level 1 evidence.
The VivoSight OCT scanner uses the company's multibeam OCT technology to noninvasively view all the layers of the skin in great detail, providing real-time, high-definition images.
The company's initial focus is in the diagnosis of nonmelanoma skin cancers (NMSCs), such as BCC. NMSC is the most common skin cancer, with approximately 3.5 million new cases in the U.S. each year.
Preliminary results from the trial will be announced at the American Academy of Dermatology (AAD) Annual Meeting in Denver, CO, this month. Also, it is expected that full results will be published in a leading peer-reviewed journal later in the year.
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