GynTect® (CE-IVD-marked DNA methylation test)

Clinical information

More and more countries change their cervical cancer prevention programs from cytology-based screening to HPV screening or to HPV and cytology co-testing with longer intervals between the tests, since HPV tests are more sensitive and objective than cytology. However, only few HPV infections lead to lesions which progress to cervical cancer – the majority are cleared by the immune system.

As a consequence of the new screening strategy more women are confronted with positive screening results, causing them to fear that they might have cervical cancer. Since standard screening methods do not have any prognostic value, disease progression from an HPV infection to cancer currently cannot be predicted. Therefore, classical care often leads to unnecessary treatment, including costly surgery, which may cause preterm birth or birth loss in ongoing and future pregnancies in women of reproductive age. In addition, a poor diagnosis leads to unnecessary long and intensive patient management, which results in a great psychological burden.

Diagnostics

The GynTect® test was developed to improve the management of women in cervical cancer screening programs. It specifically detects changes in the DNA methylation of six specific genes (ASTN1, DLX1, ITGA4, RXFP3, SOX17, ZNF671), which occur during cervical cancer development. Thus, with the help of this test one can distinguish HPV infections which will progress towards cervical cancer from infections which will not and therefore do not require treatment. Accordingly, the GynTect® test is much more specific for high grade lesions than HPV-tests and is well-suited to decide whether a colposcopy or treatment is needed after a positive HPV result.

In general, the GynTect® test is particularly suited for women with a positive (HPV) or abnormal (cytology) cervical cancer screening result who

• Are pregnant or want to get pregnant,
• Prefer non-invasive diagnostics,
• Wish to avoid long periods of monitoring and waiting for confirmatory results, or
• Wish to continue treatment with their regular gynaecologist without directly being referred to a specialist clinic.

^{Sales restrictions: The test system is only available in Benelux, Canada, Italy, Lebanon, Lithuania, Marocco, Mexico, Poland, Portugal, Rumania, South Africa and Turkey.}

Files

Info for physicians: Epigenetic markers for cervical cancer diagnostics

Info for labs: Epigenetic markers for cervical cancer diagnostics