Michelson Diagnostics, the UK-based medical device company focused on multi-beam Optical Coherence Tomography ('OCT') technology, announces the publication on-line in the British Journal of Dermatology of the full results from an independent clinical study that demonstrates for the first time the clinical value of OCT in the diagnosis of basal cell carcinoma (BCC). This observational, prospective, multi-centre study was conducted using the Company's VivoSight multi-beam OCT device.
This study highlights that using VivoSight OCT is an efficient, non-invasive way to diagnose BCC and has the potential to reduce avoidable biopsies and surgery, thereby reducing scarring for patients.
In summary, the data clearly show a significant increase in specificity (percentage that test negative when BCC is not present) to 75.3% (p<0.0001) when using OCT in the diagnosis of BCC when compared to clinical assessment alone (specificity 28.6%). In the study, use of dermoscopy in addition to clinical evaluation resulted in an increase in specificity to only 54.3%. The diagnostic sensitivity (percentage that test positive when BCC is present) of clinical evaluation alone for BCC was found to be high (90.0%) and while there was a slight increase in sensitivity when using OCT or dermoscopy in addition to clinical evaluation, it did not reach statistical significance. Importantly, overall, the study showed a sizeable improvement in the accuracy of diagnosis of all lesions from 65.8% for clinical evaluation alone to 87.4% with VivoSight OCT (a secondary endpoint of the study).
VivoSight has CE/TGA regulatory-clearance and FDA 510(k) clearance in the United States and is available for sale in Europe, USA and Australia.
Dr. Martina Ulrich, joint lead investigator for the study, commented: "This study demonstrates the clinical value of multi-beam OCT in the diagnosis of BCC in a typical clinical setting. The results published today suggest that incorporating OCT in the evaluation of suspect lesions can lead to an increase in accuracy of diagnosis and is notable for the greatly improved diagnostic specificity that is achievable over clinical evaluation and dermoscopy."
Andy Hill, CEO of Michelson Diagnostics, added: "We believe that VivoSight, based on our proprietary multi-beam OCT technology, has the potential to become the gold standard for non-invasive diagnosis and monitoring of BCC and other conditions that affect cutaneous and epithelial linings of the body. BCC is the most common non-melanoma skin cancer in humans and affects an estimated 2.8m people in the US alone. The results of the study unequivocally show, for the first time, the clinical value of using OCT in the diagnosis of tumours such as BCC and can potentially limit the need for biopsy or surgery and thus subsequent scarring."