Worldwide unique test for cervical cancer as a gamechanger for the healthcare system

Cancer is and remains one of the greatest health, medical and socio-political challenges of our time. This is also made clear by the World Health Organization’s (WHO) forecast, which predicts a 77% increase in the number of cancers detected by 2050. Of these, cervical cancer is the most common in women between the ages of 35 and 44. Effective cervical cancer screening can actually prevent the cancer, as it is very treatable if diagnosed early. However, current screening tests are too unspecific, sometimes leading to severe psychological stress for those affected and resulting in medical interventions for further clarification, which are often unnecessary. This is where a globally unique test developed in Germany for the reliable and rapid diagnosis of cervical cancer comes in, which Epitype is now aiming to bring into widespread use.

 

Cervical cancer – good early detection, inadequate clarification

Cervical cancer (cervical carcinoma) causes 350,000 deaths worldwide every year with 660,000 new cases – and the trend is rising. Despite established screening programs in Germany, 1,500 patients succumb to this particular cancer every year. In 99 percent of cases, it is triggered by an infection with human papillomaviruses (HPV), which can cause cell changes in the cervix. Although there is a reliable test for these viruses, an infection with HPV only very rarely leads to the development of cervical cancer. In fact, almost everyone is infected with HPV at least once in their lifetime – but in most cases the infection is so harmless that it is not even noticed. And even if HPV leads to cell changes – which are quite common in younger women – they usually disappear completely.

Cervical cancer only develops in very rare cases if the infection persists for years and the cells on the cervix change permanently. These precancerous stages can ultimately develop into cervical cancer. In addition to the HPV test, which only indicates whether an HPV infection is currently present, the Pap test is therefore currently the main form of cervical cancer screening. This examines the actual cell changes on the cervix. A swab sample from the cervix is examined under a microscope, which allows signs of precancerous cervical lesions – i.e. degrees of cell change – to be identified. Such a conspicuous test result enables early treatment on the one hand, but on the other hand often leads to a great deal of psychological stress for patients – even though such a test only detects an existing cell change, but not cervical cancer. The time until the next regular examination becomes a real ordeal for many of those affected.

If the Pap test even detects an advanced cell change, the results need to be clarified. This usually means an unpleasant, sometimes painful surgical procedure: a colposcopy, a cervical endoscopy, often involves the removal of tissue for further examinations and, in the case of conizations, conspicuous pieces of tissue are removed directly from the cervix. In addition to the stress that such surgical procedures entail anyway, conizations are also responsible for a fourfold increase in the probability of premature births in subsequent pregnancies.

 

Worldwide unique test for cervical cancer

Due to this unsatisfactory situation in the diagnosis of cervical cancer, researchers Dr. Martina Schmitz and Dr. Alfred Hansel set themselves the goal of working with their team to develop new tests for the diagnosis of cancer that are fast, safe and non-invasive. “We considered and still consider this situation of psychological and physical stress for women with abnormal test results to be unbearable. Every affected woman should have immediate and reliable certainty about this serious issue,” says Dr. Martina Schmitz. Dr. Alfred Hansel adds: “We want to protect women from these negative experiences and have developed a test that detects cervical cancer and its precursors at an early stage, but also reliably excludes them in other cases.”

The GynTect® test developed is based on the detection of characteristic epigenetic changes in cancer cells. These are changes that influence the gene activity of the cells without causing changes to the DNA sequence itself. Rather, these are so-called DNA methylations, i.e. methyl groups that attach themselves to the DNA. Due to their specific characteristics in cervical cancer cells, these act as highly informative biomarkers with which cervical cancer and its precursors can be quickly and reliably detected or even ruled out. These patented epigenetic markers are suitable for a wide range of applications, from early detection and treatment decisions through to aftercare.

No surgical intervention is necessary for the GynTect® test. As with the Pap test, a swab sample from the cervix taken by the gynecologist is sufficient. In the laboratory, the GynTect® test is used to examine the DNA of the cervical cells for epigenetic changes. This allows a precise distinction to be made between cell changes that heal on their own and those that can develop into cancer. The test result is available within a few working days and can be transmitted by the doctor. Based on the available study data, GynTect® is suitable for making a clear statement on the disease status of patients with an abnormal Pap smear. In studies to date, the test has identified 100 percent of all cervical cancer cases.

 

Significance and potential for patients and the healthcare system(s)

The GynTect® test is a reliable and gentle, non-invasive method of diagnosing cervical cancer, which quickly provides certainty for those affected and thus significantly reduces psychological and physical stress. It can also effectively counteract the problem of overtreatment. In this way, numerous unnecessary conizations, i.e. tissue removal due to an abnormal Pap test, can be avoided. Around 90,000 of these surgical procedures are performed in Germany every year, which fortunately prevent around 10,500 actual cases of cancer. Conversely, however, this means that almost 80,000 conizations are unnecessary – including the burden on the patients, the 23 percent increased risk of premature births and ultimately the inappropriate expenditure for the healthcare system. Added to this are the hundreds of thousands of women who are referred for colposcopy every year following conspicuous HPV and Pap findings. Here, too, it is clear that only a small proportion of these women are actually diagnosed with a relevant precancerous stage or cancer. The majority, on the other hand, showed no dangerous cell changes on the cervix. All in all, annual savings of around 50 million euros in the German healthcare system are currently easily possible through the use of the GynTect® test. Worldwide, the potential for the benefit of patients and in terms of expenditure within the various healthcare systems is in the billions.

 

The vision: low-burden early detection of cancer worldwide

Dr. Timm Zörgiebel summarizes the vision of the three managing directors of Epitype GmbH as follows: “Our goal is to make a valuable contribution to the elimination of cervical cancer as part of the WHO’s strategy and to spare as many women as possible unnecessary stress in the early detection of cancer with our gentle and reliable tests. As an entrepreneur and employer, we are also committed to developing Epitype into the leading provider of epigenetic cancer diagnostics in women’s health and a safe and growing employer in Germany.”

On the way there, the expansion of the international network and the intensification of political persuasion work are planned, as are the talks already initiated with German health insurance companies. There is a particular focus on participation in scientific studies: on the one hand, large international comparative studies are planned in cooperation with the long-standing Director of Tumor Biology in Heidelberg, Prof. Magnus von Knebel-Doeberitz. In addition, a large-scale study by Prof. Peter Hillemanns from the Hannover Medical School has been applied for next year in order to compare various clarification tests in HPV-positive women with more than 70,000 patients. The results will then form the basis of the argumentation for the German HPV screening program. These scientific activities will be embedded in an intensification of sales activities in Germany, Europe and Asia and later the entry into the US market.