Test for cervical cancer ideal for clarification in case of positive HPV result

Independent study in cervical cancer screening:

The GynTect test for cervical cancer screening is highly informative regarding whether cervical cancer is present or likely to develop. In addition, GynTect is well suited for sampling by the patient herself (self-sampling). All these points are confirmed by a recently published study from China.

The Chinese diagnostics company GeneoDx, a subsidiary of the Sinopharm Group, markets the GynTect clarification test under exclusive licence in China. GeneoDx supported a study in which scientists examined the predictive power of GynTect in more detail. The study with the short title “Methylation panel for the clarification of HPV-positive women” has now been published.

Subject of the study

9,526 women from rural areas of China took part. These have difficult access to medical services. For this reason, the women performed the smear sampling for the HPV test themselves. Many of them participated in cervical cancer screening for the first time.

Of the 9,526 women, 1,758 tested positive for HPV. The samples of these women were then tested for HPV types 16 and 18. Furthermore, smear samples were taken by the doctor and GynTect was performed on these samples. The women were also examined by colposcopy and, if necessary, biopsy and continued to participate in the study. They were followed up annually with HPV tests. HPV-positive women again received a colposcopy and, if necessary, a biopsy was taken.

“If there is an abnormality, women currently are examined every three to six months. This is not feasible for many in poorly accessible regions. This problem does not only exist in China, but in many regions worldwide. With GynTect, all it takes is a smear test and the women have certainty. This way we can save lives,” explains Dr Martina Schmitz, Managing Director of oncgnostics GmbH.

Study shows potential of GynTect

The study demonstrated that GynTect, with which methylation markers are detected, has very good predictive power, especially in combination with HPV typing: women who were initially both HPV16 or HPV18 positive and GynTect positive had the highest risk of developing the disease. Women who were infected with a different HPV type and were GynTect-negative had the lowest risk.

Based on several references, the authors of the study also assume that GynTect is suitable to be used as a self-sampling test. This means that the women take the sample themselves, which is then sent to a laboratory for testing. The intermediate step via medical personnel is eliminated. In addition, the study concludes that GynTect has the potential to be used in primary screening. The referral rate for colposcopy was reduced by 55.6% through the use of GynTect. Thus, the study also shows that overdiagnosis and overtreatment can be avoided through GynTect.

“For us, the study confirms once again that we are on the right track to develop our screening test GynTect into a test that will be an integral part of cervical cancer screening. If we then also develop a reliable self-sampling test, we can revolutionise cervical cancer screening,” summarises Dr Martina Schmitz.

How does cervical cancer develop?

The main cause of cervical cancer is infection with human papillomaviruses (HPV). It takes several years from infection to the development of cancer. Modern screening methods can detect cervical cancer early and treat it well. Deaths are therefore preventable.

Figures for Germany (all figures annually) [1]

6 million women infected with HPV[2], of which several hundred thousand have cytological abnormalities.
4,300 are diagnosed with cervical cancer
1,600 die from cervical cancer

Figures for China (all data annually) [3]

Around 110,000 women are diagnosed with cervical cancer
around 59,000 die of cervical cancer

How GynTect works

The molecular biological test GynTect, developed by oncgnostics, determines at an early stage whether a patient with an abnormal finding in the cervical cancer screening is developing or already has a cervical carcinoma (cervical cancer) that needs to be treated.

The screening test detects epigenetic changes, so-called DNA methylations. All that is needed to carry out the test is a smear, as is also taken for thin-layer cytology or the HPV test.