Biotech company oncgnostics GmbH has received CE-IVD approval to market the “GynTect” test for the detection of cervical cancer and its precursors. The test, based on cellular epigenetic biomarkers, delivers test results quickly and reliably, thus enabling cases of cancer to be identified faster and improve therapeutic success. The test greatly simplifies the risk assessment portion of cervical cancer screening and therefore can reduce unnecessary operations. GynTect is ready to be introduced immediately throughout EU laboratories and clinics.
Europe-wide marketing authorization with the CE-IVD labeling has now been granted for GynTect. oncgnostics will begin the market launch of the patented test to other European countries beyond Germany in the coming months. The market launch in North America and Asia is in the works.
Cervical cancer is almost always curable in its early stages.
Unlike other screening methods, GynTect delivers results that give a definitive answer about cancer risk. Even the first precursors can be identified by this diagnostic method, enabling a quick treatment decision. GynTect uses the same sample used for the Pap smear or HPV test, thereby making an additional cell collection from the patient unnecessary. GynTect provides rapid and reliable clarification to patients with ambiguous Pap and HPV findings and helps to avoid unnecessary treatments, as not every infection automatically leads to cancer. Surgical procedures are not necessary in women who are infected with HPV but exhibit no cancer cells.
“Almost every woman experiences an HPV infection during her life, but only a few cases will develop into cervical cancer. It is still the third most common cancer in women worldwide, with approximately 530,000 new cases per year and more than half of these proving fatal. Each year, there are 55,000 new cases reported in Europe, 4,500 of which occur in Germany (World Health Organization, 2010). In my eyes, GynTect is a breakthrough in screening and can help to reduce this number,” said Prof. Dr. Matthias Dürst, Virologist and Head of the Gynaecologic Molecular Biology functional unit at the Jena University Hospital’s Women’s Clinic.
A spin-off of Jena University Hospital’s Women’s Clinic, oncgnostics focuses on in vitro diagnostic tests for the early and accurate detection of cancer utilizing proprietary epigenetic biomarkers. The diagnostic products allow earlier detection of more cancer cases and thus contribute to the improvement of therapeutic success. The initial product developed, GynTect®, allows the rapid and reliable detection of cervical precancerous lesions and cancer.