Oct 22 2015
Multi-centre, Prospective Study Data Published in Journal of Clinical and Aesthetic Dermatology
Michelson Diagnostics, a medical device company focused on applications of multi-beam Optical Coherence Tomography (‘OCT’) technology, today announces data showing that use of its VivoSight OCT scanner significantly improves diagnosis of basal-cell carcinoma (BCC) at an earlier stage and reduces diagnostic biopsies by 36%. Scanning with VivoSight OCT provides clinicians with continuous images of the epidermis and superficial dermis of the skin that can be interpreted by a medical professional during the diagnostic process. The data, from a multi-centre, prospective study conducted in the US is published in the October issue of the Journal of Clinical and Aesthetic Dermatology.
“The data showed that VivoSight OCT improved diagnostic certainty for BCC by a factor of four over clinical examination alone, and improved diagnostic accuracy by 50%,” explained Orit Markowitz, MD, Assistant Professor of Dermatology, the Icahn School of Medicine at Mount Sinai Hospital. “We also found that the addition of OCT to other standard assessments can improve the false-positive rate and give a high degree of certainty for ruling in a positive diagnosis for BCC. By sending these patients straight to surgery, we saw a 36% reduction in overall biopsies.”
Compared to clinical and dermascopic evaluation, VivoSight OCT significantly (p<0.01) improved sensitivity and specificity, correctly diagnosing in 87.8% of BCC cases compared to 57.4% for clinical and 69.6% for dermoscopy. The use of VivoSight OCT in the diagnosis of BCC also allowed more than 1 in 3 patients (36%) to avoid a diagnostic biopsy.
“This publication builds on existing excellent data showing that VivoSight scanning is emerging as a vital tool for the non-invasive diagnosis and monitoring of BCC and other non-melanoma skin cancers,” stated Andy Hill, Chief Executive Officer of Michelson Diagnostics. “Following the successful commercialisation of the VivoSight scanner in Europe and select markets internationally, Michelson Diagnostic is expanding potential applications of the OCT technology, including into melanoma diagnosis.”
VivoSight has CE/TGA regulatory-clearance and FDA 510(k) clearance in the United States. It is available for sale in Europe, USA and Australia.