Human papillomaviruses are a group of viruses that may evoke warts. All these HPV types differ genetically, and they can infect the skin or mucosal tissue, not only but preferentially in the anogenital region. HPV infections are always locally restricted and do not spread to more distant parts/organs of the body.

Of the more than 150 types of HPV, a small group, the so-called high-risk human papillomaviruses (hr-HPV), may cause precancerous lesions and, if not diagnosed and treated early, cancer (e. g. cervical cancer, tonsillar cancer).

The genital HPV types are classified into two groups: low and high risk HPV. Low-risk HPV (e.g. 6, 11, 42, 43, 44) are almost never detected in case of a cervical cancer. High-risk HPV types (e.g. 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58) are detected in 99.7% of all cervical cancer cases. In 70% of the cases, HPV16 and HPV18 are detected. Only women with long-term infection with high-risk HPV and subsequent cervical lesions have a risk of developing precancerous lesions and cancer. It is well-established nowadays that HPV infection ist he main risk factor for the development of cervical cancer.

According to the already performed trials, GynTect® is suitable for all women who want to get further clarification after an abnormal Pap smear and/or a positive HPV test, if surgery is already required or if a watchful waiting strategy could demonstrate if an HPV infection and a tissue abnormality may heal without treatment.

Results obtained during clinical trials indicate that upon a positive GynTect® test result a severe cervical lesion, a so-called CIN3, or even a cervical carcinoma (from a low-grade CIN1 or CIN2) may develop or already be present. Invasive diagnostics (colposcopy and, if required, biopsy, both in a specialized colposcopy clinic) should be performed after a positive GynTect® test result. During this examination conspicuous surface of the cervix should be examined very thoroughly, and biopsies taken during this examination should be diagnosed by histopathology.

In case of a negative test result a precancerous leson or cancer can almost be excluded. We recommend a re-examination after 6 months, with HPV testing performed first.

GynTect® is a reliable molecular test that may clarify if a patient with unclear Pap test results (Pap III, PAP IIID, evtl. Pap IVa) and/or an HPV infection already has a precancerous lesion of carcinoma that requires treatment.

GynTect® aims at the detection of specific epigenetic changes that may occur early in cervical carcinogenesis. If these changes are not detectable, watchful waiting may help avoiding unnecessary surgery.

Additional tests are required in order to clarify if a precancerous lesion or cancer is the reason for an abnormal Pap smear result. GynTect® is an easy to perform and reliable test which detects epigenetic changes specifically occuring in cancer tissue. The same cervical smear material that is currently used for Pap testing is used for GynTect®.

If a normal cell develops into a tumor cell, this leaves traces in the genetic material, the DNA, of the tumor cells. Such epigenetic traces, a specific methylation of certain DNA regions, are detected with tests developed by oncgnostics. Our studies demonstrate that the markers validated for GynTect®, can easily be detected in smear material from the cervix of women with disease.

In oder to determine whether an abnormal Pap smear result originates from a cervical disease requiring treatment, additional tests and examinations are required. With our GynTect® procedure we reliably identify epigenetic changes which occur specifically in cancer tissue. For this test we use the same material that is currently used for the Pap test.