2020 was a challenging year – also for our company. Nevertheless, we look back on successful achievements.

GynTect® convinces in test comparison

In November, the journal Clinical Epigenetics published a comparative study on cervical cancer diagnostics tests. Two tests based on epigenetic markers, oncgnostics’ GynTect® and QIAGEN’s QIAsure, were tested on a selection of patient samples. Both tests may be used to identify clinically relevant, HPV-induced cervical disease that may develop into cancer. The aim of the study was to determine not only the sensitivity but also the specificity of the tests, which means how frequently a test delivers a false-positive result. Both tests demonstrated a very good sensitivity for high-grade lesions, especially for cancer cases. However, for GynTect®, the specificity was significantly higher, which means that the rate of false-positive results among healthy HPV-positive women was much lower. Thus, GynTect® may be preferable, due to its higher specificity for CIN2+ or CIN3+.

Achievements: active in research despite Corona

In August 2020, a study on psychological stress in connection to abnormalities found in cervical cancer screening was published, with our contribution. More than 3700 women participated in this scientifically supported online survey. Women with abnormal Pap smear findings or with an HPV infection stated, among other concerns, that they are worried about developing cancer. Even though neither an abnormal Pap smear finding nor an HPV infection does provide a reliable indication of cancer. Nearly half of those affected even expressed fears of dying from cervical cancer. The results were published in the journal Archives of Gynecology and Obstetrics.

Furthermore, we have made significant progress in the diagnostics of Head-and-Neck tumors: Since 2019, we have developed a test based on proprietary DNA methylation markers that may be used in Head-and-Neck cancer diagnostics. In 2020, the corresponding study “OncSaliva” started in the University Hospital Jena. Four more centers will be added by the end of the first quarter of 2021. A total of 150 patients provide saliva and blood samples at the time of their cancer surgery. In addition, we obtain tissue samples from the tumor for analysis. The samples are tested for the methylation markers. 150 healthy subjects are also included, from whom tissue and saliva samples are collected. During the subsequent post-surgical follow-up care, the patients enrolled in the study regularly provide saliva samples for recurrence detection for up to two years. Our scientists analyze the methylation markers in the saliva. This non-invasive method may enable a timely detection of recurrences in the follow-up. The study will run until the end of 2023.

Outlook for 2021: New cooperation and appearance at Eurogin

The results of the GynTect®-PRO study will be available in May. Our company started a three-year follow-up study with the GynTect® test procedure in 2017. For this trial, patients from ten study centers in Germany were enrolled. It is intended to show that young patients with a negative GynTect® result do not develop cervical cancer despite conspicuous changes observed at the cervix uteri. Instead, the cell changes heal by themselves.

In 2021, we will reach another milestone in our international sales activities. Our company recently negotiated a partnership with the international diagnostics group EUROIMMUN, a PerkinElmer company.

Save the Date: We will participate at the international, multidisciplinary HPV congress Eurogin from May 30th to June 1st 2021.

Picture: Pharmaceutical biotechnologist Theresa Erler in the oncgnostics laboratory / © Eberhard Schorr