The biotechnology company Oncgnostics is researching a method for diagnosing head and neck tumours, together with the clinical department for General Ear, Nose and Throat (ENT), at the Medical University of Graz, as part of the OroCa-Graz study.
Each year, 550,000 people worldwide develop carcinomas of this type. As only advanced stages of tumours are often diagnosed, more than 300,000 of those affected die each year.
The study aims to demonstrate that the diagnostic method developed for head and neck tumours, and especially mouth and throat cancer (oropharyngeal cancer), can reliably and early detect malignant tumours using non-invasive saliva samples.
Excessive alcohol and tobacco consumption are among the main risk factors for head and neck cancer. In recent years, there has also been an increase in cases of carcinoma in the mouth and throat area, in which infection with the human papillomavirus (HPV) was found.
The rate of these HPV-associated cancers increases by 2.1% annually. Non-HPV-associated head and neck cancers decreased slightly by 0.4% over the same period. In Germany, a current proportion of 40% of HPV-induced diseases is assumed, and the trend is rising.
The OroCa-Graz study is led by Prof Dr Dietmar Thurnher, head of the General ENT Department at the Medical University of Graz. He explains: “Despite increasing cases, the treatment of head and neck cancer has not made any significant progress in the last 20 years.
“Besides new diseases, half of the patients return as so-called tumour recurrence within two years of completing therapy. Furthermore, no early diagnosis has yet been established for head and neck tumours. Our goal is to change that.
“By examining the relationship between oropharyngeal carcinomas, HPV infections and DNA methylation markers, new ways of early diagnosis, as well as secondary and tertiary prevention, are emerging.”
Secondary prevention is aimed at people with an increased risk of disease, such as smokers. With preventive examinations and clarification, as well as screening tests, malignant diseases, especially in risk groups, could be diagnosed at an early stage or abnormalities could be clarified.
Currently, the throat is inspected when symptoms arise. Tertiary prevention measures are aimed at tumour patients who are in regular clinical follow-up after treatment.
OroCa-Graz course of study
As part of the OroCa-Graz study, tissue and saliva samples from patients with oropharyngeal cancer are examined comparatively. By submitting a simple saliva sample, complaints in the head and neck area should be clarified later.
The detection of malignant disease is carried out via the detection of tumour-specific DNA methylation markers, which were developed by Oncgnostics. The HPV status of all samples is also determined.
Based on these results, the scientists analyse how sensitive the tumour detection by the methylation markers is and whether there is a connection between the occurrence of the tumour markers and an HPV infection.
Additional saliva samples are taken during follow-up. The idea is that tumour markers that have already been detected in the primary tumour return in the development of recurrences. If the tumour markers are detected in the follow-up, action can be taken at an early stage.
Research on DNA methylation markers since 2012
Since its foundation in 2012, Oncgnostics has been specifically engaged in the search for DNA methylation markers, including head and neck tumours.
So far, a set of potential tumour markers based on tissue and swab samples has been established for the disease. One of these tumour markers is already used in the diagnosis of cervical cancer in the GynTect® test.
“Changes in the DNA methylation pattern occur early in tumour development,” said Dr. Martina Schmitz, CEO of oncgnostics GmbH. “By detecting our cancer-specific biomarkers, we can check, for example, if cancer precursors are present.
“In the future, the application could be a powerful tool for early detection in the context of cancer screening and as part of the follow-up examinations for oropharyngeal carcinomas.”