Michelson Diagnostics announces completion of data collection in Vivosight OCT trial for BCC diagnosis
Michelson Diagnostics, the UK based medical device company focused on multi-beam Optical Coherence Tomography (‘OCT’) technology, today announces that it has completed scanning and data collection for a large 250-patient, multi-centre, prospective clinical trial of the diagnostic performance of its VivoSight™ OCT scanner in diagnosing superficial basal cell carcinoma (BCC), the most common form of skin cancer.
Preliminary results from the trial are to be announced at the American Academy of Dermatology (AAD) Annual meeting in Denver, in March 2014. It is expected that full results will be published in a leading peer-reviewed journal later in the year.
The study compares how well dermatologists were able to diagnose basal cell carcinoma using the VivoSight OCT scanner against the gold standard of skin biopsy with histopathology, and visual examination with a dermatoscope. Conducted at six leading dermatology centres in Germany, this is the first diagnostic study of OCT in the field of dermatology that is designed to generate level 1 evidence.
VivoSight is a medical imaging system which uses Michelson Diagnostics patented, multi-beam OCT technology to non-invasively view all the layers of the skin in great detail for the first time. VivoSight provides clinicians with real-time, high definition images of the skin through a fast, accurate and reliable imaging system. The Company’s initial focus is in the diagnosis of non-melanoma skin cancers (‘NMSC’), such as basal cell carcinoma. NMSC is the most common skin cancer with approximately 3.5 million new cases in the USA each year.
Dr Gordon McKenzie, Director of Clinical Development at Michelson Diagnostics, said: “We are very pleased that patient scanning and data collection has been completed. The study has gone exceptionally well and we eagerly await the preliminary findings. We would like to thank all the VivoSight clinical investigators and the patients who participated in the trial.”
Jon Holmes, CEO of Michelson Diagnostics, added: "We look forward to sharing the preliminary results from this important clinical study. It will hopefully provide level 1 evidence for the first time of the diagnostic value of OCT in dermatology and specifically its use in the detection of non-melanoma skin cancers such as basal cell carcinoma.”