Recent developments in optical coherence tomography (OCT) address skin cancer diagnosis.
MedLumics (Madrid, Spain) has launched a three-year initiative to translate research into new clinical applications—with help from $4.9 million (€3.6 million) in Series A funding from EU joint investors. Called the BiopsyPen Project, the initiative is led by MedLumics and the Medical University of Vienna (Austria), along with European members including VTT Finland (Espoo, Finland), Delft University of Technology in The Netherlands, Exalos (Schlieren, Switzerland), the Polytechnic University of Madrid, and Optocap (Livingston, Scotland). The organizations are working to develop a handheld system for point-of-care diagnosis in dermatology. It will address the need for a rapid, noninvasive way to support diagnosis and monitoring of skin cancers without tissue biopsies.
MedLumics is developing the first-generation device, expected to launch later in 2014, which combines epiluminescent microscopy and OCT in a built-in display that integrates with patient-centered workflows. If approved by regulatory bodies, it will be the first point-of-care OCT device to integrate all optical and electrical components in a compact, microchip-based system able to produce dynamic, real-time, high-resolution diagnostic images with tissue penetration up to 2 mm.
BiopsyPen, expected in 2017, will build on the first-generation device with additional clinical workflow advantages. Performance improvements will be driven by such technologies as Doppler OCT, elastography, and polarization-sensitive OCT to provide greater image contrast for discrimination of malignant tissues. These technologies will also open the door for additional applications for the platform.
A second development is Michelson Diagnostics' (Orpington, England) achievement of positive results in a recent multicenter, prospective clinical trial for basal cell carcinoma diagnosis using its VivoSight multibeam OCT system. More than 250 patients with clinically suspicious lesions were scanned at six centers. 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 (the current gold standard). "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," said Dr. med. Martina Ulrich AAD, who presented the findings at the American Academy of Dermatology's 72nd Annual Meeting (March 21-25, 2014; Denver, CO).