Use of VivoSight OCT Scanner Significantly
Improves Early-Stage Diagnosis of Basal Cell
Carcinoma and Reduces Need for Skin Biopsies
Multi-centre, Prospective Study Data Published in The Journal of Clinical and Aesthetic Dermatology
Maidstone, UK, 20th October 2015 – 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.
For further information
||Tel: +44 (0)20 8308 1695
|Andy Hill, Chief Executive Officer
||Tel: +44 (0)20 7318 2955
Notes to editors
Study Summary: VivoSight OCT-assisted diagnosis of BCC
This multi-centre, prospective US study was conducted to determine the diagnostic accuracy of OCT for basal cell carcinoma (BCC), and the proportion of biopsies that could be avoided if OCT is used to rule-in surgery. Consecutive patients with clinically challenging pink lesions suspicious for BCC were examined. Clinical, dermoscopic and VivoSight OCT images were obtained for all subjects. At each stage the clinician made a diagnosis (pathology + sub-type if applicable), and assessed their own confidence in the diagnosis. Of the 115 lesions examined, 70 were histologically confirmed as BCC. The most common sub-type was nodular. The percentage of correct diagnoses was 57.4% (clinical), 69.6% (dermoscopy) and 87.8% (OCT). The use of OCT significantly increased the proportion of lesions where clinicians were certain about the diagnosis, a significant challenge in this difficult subset of lesions. Clinicians indicated that they were certain (>95% confident) in 17% of clinically examined lesions, increasing to 38.6% of lesions with the addition of dermoscopy and then to 70% with the further addition of OCT.
Basal Cell Carcinoma
Basal Cell Carcinomas (BCCs) are abnormal, uncontrolled growths or lesions that arise in the skin’s basal cells, which line the deepest layer of the epidermis (the outermost layer of the skin). BCCs often look like open sores, red patches, pink growths, shiny bumps, or scars and are usually caused by a combination of cumulative and intense, occasional sun exposure. In 2010, an estimated 2.8 million cases of BCC were diagnosed in the US, and the figures have continued to climb. BCC is the most frequently occurring form of all cancers. More than one out of every three new cancers is a skin cancer, and the vast majority are BCCs. (http://www.skincancer.org/skin-cancer-information/basal-cell-carcinoma)
About the VivoSight OCT System and Michelson Diagnostics
Michelson Diagnostics develops, manufactures and markets the VivoSight multi-beam Optical Coherence Tomography (‘OCT’) scanner, a point-of-care, real-time tissue-imaging device. The patented technology, which has CE/TGA regulatory-clearance and FDA 510(k) clearance in the United States, provides clinicians with continuous images of the epidermis and superficial dermis of the skin that can be interpreted by a medical professional. Given the unprecedented image resolution and image quality, VivoSight OCT has many potential clinical applications beyond the initial focus in dermatology.
The Company’s vision is for the VivoSight OCT system to become the standard-of-care for the non-invasive diagnosis and treatment monitoring of certain diseases and conditions that affect cutaneous and epithelial linings of the body. Michelson Diagnostics currently generates revenues from the first commercial application of VivoSight, in the diagnosis of non-melanoma skin cancer (NMSC).
VivoSight has regulatory clearance in Europe, the USA and Australia, for use by trained clinicians in their assessment of the patient’s medical condition. VivoSight is currently sold in Germany where the scans are reimbursed for patients with private healthcare insurance. Further clinical studies are presently being conducted at leading centres in the United States.
Michelson Diagnostics, based in Maidstone, Kent, was founded in 2006 and has 20 employees, and has offices in Germany and USA. It is supported by syndicate of venture capital, corporate and private investors, including funds managed by Octopus Investments, Smith and Nephew, Catapult Ventures and Angel Investors.
For more information about Michelson Diagnostics and the VivoSight system, see www.us.vivosight.com.