Office for the Valorization of Biomedical and Pharmaceutical Research (UVaR)

Office for the Valorization of Biomedical and Pharmaceutical Research (UVaR) - Region of Tuscany

Fondazione Toscana Life Sciences Via Fiorentina, 1 53100 Siena – ITALIA

Markers of melanoma and uses thereof

managed by UVaR - Toscana Life Sciences


Cutaneous Melanoma is characterised by high mortality (2,7/100.000 USA) and continuously increasing incidence worldwide (Italy: 13,9/100.000, 2003-2005; APC +3.8%;USA: 21/100.000; APC +2,6% 1985-2009). It is strongly felt the need to define prognostic markers to appropriately direct the clinical management (folow-up/therapy) of patients as well as predictive markers of response to therapy to identify the most appropriate treatment for each patient, concomitantly avoiding side effects deriving from the unnecessary exposure to drugs not effective for the specific patient. Researchers at the University Hospital of Siena and National Cancer Institute of Aviano have identified and patented a method for determining prognosis and predicting or monitoring response to therapy of patients affected by cutaneous melanoma through the evaluation of the methylation of different genomic DNA sequences, including the Long Interspersed Nucleotide Element-1 ( LINE-1 ) repetitive DNA sequences and/or the concomitant methylation profile of specific groups of genes defined as methylation signature.


The invention presents a variety of advantageous features:
• Far superior stability of DNA methylation markers in clinical samples as compared to
RNA-based markers:
• Applicability to different types of biological samples, including archival FFPE tissues
• High sensitivity of the assays;
• Potentially evaluable in serum/plasma to allow easy to run routine screenings.




The present invention is related to the identidfication of DNA methylation markers in melanoma patients within the same sub-stage of disease (e.g., AJCC stage IIIC). Specifically, overall genomic DNA methylation, evaluated on Long Interspersed Nucleotide Element 1 (LINE1) repetitive sequences, identifies patients with lower levels of methylation as having a significantly improved survival as compared to patients with LINE1 hypermethylated tumors. Similarly, specific methylation signatures composed by the methylation status of different genes are able to sort patients into classes with increasded or reduces survival rates.


Readiness Level (TRL)

technology validated in lab(The pie chart refers to the entire portfolio contained in the database of the helpdesk)

Technology Readiness Levels (TRL) are a method of estimating technology maturity of Critical Technology Elements (CTE) of a program during the acquisition process. The use of TRLs enables consistent, uniform, discussions of technical maturity across different types of technology.

Patent Grading Report

Patent Grading Report

The Grading Patents Report evaluates and grades US patents

Sample Buy from Wisdomain


Current status

PCT Application


Available for

sponsored research agreement, option agreement, licence agreement


Michele Maio (Medical Oncology and Immunotherapy, University Hospital of Siena, Italy ) Luca Sigalotti (National Cancer Institute - AVIANO)

EU-Japan Centre
European CommissionMeti