Method for early detection of head and neck squamous cell carcinoma

The present invention refers to a method performed in vitro to determine an Oral Squamous Cell Carcinoma (OSCC), preferably at early stage, based on the measuring the DNA modification of a specific set of genes

Patent title Method for determining a head and neck squamous cell carcinoma
Thematic area Health
Inventors Davide Bartolomeo Gissi, Achille Tarsitano, Luca Morandi
Protection Europe, USA, China, Brazil
Licensing status Available for development agreements, option, license and other exploitation agreements
Keywords DNA methylation, Bisulfite next generation sequencing, Early detection, Oral squamous cell carcinoma, High grade squamous intraepithelial lesion, Quantitative DNA methylation analysis, Prognosis
Filed on 04 November 2016

Oral and pharyngeal cancer are the sixth most common cancer in the world, approximately 600,000 cases per year. The mortality rate of these tumors is 50% within 5 years after diagnosis and are mostly related to tobacco smoking and alcohol intake. Oral squamous cell carcinoma (OSCC), which represent 95% of all oral cancers, is usually diagnosed in an advanced stage, which is associated with worse prognosis, higher radio and chemotherapy morbidity and compromised patient’s quality of life. If the disease is identified in earlier stages the overall five-year survival rate is greater than 80%.

Nowadays oral cancer is usually diagnosed by an incisional biopsy that requires a minimally invasive surgical approach, that can create discomfort and can be refused by the patient. Therefore the development of non-invasive methods is an attractive strategy to reduce the burden of oral cancer. 

The present invention is related to a method and a kit for early detection of patients at risk to develop OSCC and its precursor (high grade squamous intraepithelial lesion - HG-SIL) by a quantitative DNA analysis that is able to recognize a particular pattern modification indicative of HG-SIL and/or OSCC.

Furthermore, the same DNA modifications in oral mucosa close to surgically resected area in subjects treated for OSCC are indicative of recurrence and/or a poorer prognosis.

Application fields

  • Early diagnosis of oral cancer
  • Prognosis prediction in OSCC patients


  • High Specificity
  • High Sensitivity
  • Not invasive
  • Able to detect oral cancer at an early stage (early diagnosis)
  • Able to predict prognosis in patients surgically treated for OSCC
Page published on: 09 November 2017