Study shows VivoSight OCT is able to differentiate between actinic keratosis (AK) and basal cell carcinoma (BCC) by quantification of signal intensity and layer thickness
Data Published in The Journal of the European Academy of Dermatology and Venereology (JEADV)
Maidstone, UK, 17 March 2016 – Michelson Diagnostics, a medical device company focused on applications of multi-beam Optical Coherence Tomography (‘OCT’) technology, announces data confirming the ability for VivoSight OCT to differentiate between actinic keratosis (AK) and basal cell carcinoma (BCC). This statistically significant data proves VivoSight’s capabilities as a non-invasive, objective method for diagnosing and monitoring the treatment of these diseases.
Data from this study, published in The Journal of the European Academy of Dermatology and Venereology (JEADV), showed statistically significant differences in the signal intensities and the epidermal thickness measurements of AK and BCC. Results also showed an excellent correlation between OCT and histology. Being able to determine the thickness of a lesion is clinically important as topical agents, used in the treatment of AK and BCC or photodynamic therapy, are most effective in lesions of less than 1 mm thickness.
“In the majority of cases it is clinically and dermoscopically possible to differentiate between AK and BCC, but there are difficult situations, especially in early cases or during topical therapy, where the diagnosis, grading, subtype and/or lesion thickness is unclear” explained author Professor Julia Welzel, Klinikum Augsburg, Germany. “This data published shows that VivoSight OCT is not only able to differentiate between the two diseases by means of epidermal thickness and signal intensity measurements but also able to be used as a non-invasive technique to determine and monitor the treatment. This technology significantly improves the diagnostic methods currently used resulting in better outcomes for patients”
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Notes to editors
A total of 301 lesions (188 BCCs and 113 AKs) of 125 patients (51 female, 74 male, median age 70.5, age range 39–95 years) were clinically as well as dermoscopically diagnosed and investigated with OCT before therapy. Using ImageJ, OCT signal intensity measurements were analysed for each OCT image. Further anaylsis was also performed to measure the thickness of BCC tumours, the stratum corneum, the epidermis in AKs and the epidermis above BCCs. The results showed that the mean signal intensity for BCCs was brighter compared to that of the dermis of AKs. AKs also showed a higher mean epidermal thickness in comparison to the epidermis above BCCs. In conclusion, AKs can be significantly discriminated from BCCs through epidermal thickness and signal intensity measurements.
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, non-invasive 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 trained medical professional to aid their assessment of the patient’s condition. Given the unprecedented image resolution and image quality, VivoSight OCT has many potential clinical applications beyond the initial focus in dermatology. The ‘Dynamic OCT’ technology is a software add-on and has CE regulatory clearance; FDA 510(k) clearance is currently pending.
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).
Michelson Diagnostics, based in Maidstone, Kent, was founded in 2006 and has 16 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.