Challenge Cutaneous melanoma is the most deadly form of skin cancer with a rapidly increasing incidence rate. Worldwide in 2012 there were 232,000 new cases and 55,000 deaths. Currently patients are treated on the basis of disease prognosis, where prognosis is based on factors such as thickness of mole and family history of disease. These markers are not completely reliable and often patients are either overtreated: meaning they follow unnecessary surveillance programs and experience unrest due to perceived risk of cancer progression; or undertreated meaning that the cancer progresses undetected at a fast rate (2 out of 3 patients who metastasize received a negative outcome from Sentinel Lymph Node Biopsy (SLNB).
Opportunity With a growing incidence the melanoma therapeutics market is expected to quadruple by 2023. MLA Diagnostics will initially focus on predicting patients for SLNB, which could generate revenues of over €14 million by 2026. Large future growth is expected with replacement of
Solution Methylation of the promoter of lymphocyte antigen 75 (LY75), also known as CD-205 or DEC-205, is a strong marker that predicts poor clinical outcome, independent of the currently used prognostic markers in an independent melanoma series. A test based on a patient’s own sample can thus determine if a patient has a poor prognosis. By determining a patient’s expected outcome, through a simple test performed by the pathologists, a different course of treatment (either more or less intensive) can be chosen.
Status The MLA Diagnostics biomarker has been validated on 123 primary melanomas in a patient series in Maastricht, and a subsequent independent analysis in TCGA data in 44 primary melanomas. Further validation in an independent series is currently underway.
The innovation has been patented.