Welttag der sexuellen Gesundheit. Bild: melitas

There are many more aspects to the topic of sexual health than are apparent at first glance. We want to use World Sexual Health Day as an opportunity to draw attention to cervical cancer, which develops from a sexually transmitted HPV infection.

Definition of sexual health

The World Health Organization (WHO) defines sexual health as a state of mental, emotional and spiritual well-being. Thus, it does not only mean the absence of disease or dysfunction. The WHO definition also includes respect for sexual rights of all people to have sexual experiences that are free from coercion, discrimination and violence.

World Health Organization

Sexual health and cervical cancer

When talking about sexual health, cervical cancer also has to be discussed. Because already the development of cervical cancer is related to the sexual activity of the affected woman. An infection with human papilloma viruses (HPV) is responsible for the development of cancer of the uterine cervix. These are usually transmitted during sexual intercourse. The HP viruses are widespread. Thus, almost everyone becomes infected with HPV at least once in his or her life. In most cases, this is not bad at all. Most people do not even notice their infection. But in a few cases, HPV infection can develop into e.g. cervical cancer.

Cervical cancer is curable when detected early

The good thing, however, is that cervical cancer develops slowly, over years and in preliminary stages. For the women affected, the chances are therefore good that the disease will be detected early, and treated in good time. For this reason, every woman should take advantage of the cancer screening measures offered by her gynecologist.
HPV is also associated with other cancers, including cancer of the mouth and throat, anus, penis, vagina and vulva.

HPV-positive or Pap smear is abnormal

Depending on the age of the woman, screening for cervical cancer includes a Pap test and/or a test for HPV. If the tests reveal abnormalities, there is usually only a hint of possible cancer. Sometimes the tests give a false alarm, as the HPV infection heals without any problems or slight abnormalities disappear on their own. For this reason, the gynecologist decides whether further examinations are necessary or whether the affected woman should repeat the tests after a certain period of time, usually three to six months. This procedure is also called watchful waiting.

Unclear findings put a strain on the psyche

Unclear findings place a great deal of psychological strain on affected women. This was made clear in a study published in 2020. This psychological stress can even go so far that the affected women develop signs of post-traumatic stress disorder. For this reason, we are campaigning for more accurate and rapid diagnostics of cervical cancer and for more comprehensive education.

World Sexual Health Day raises awareness

World Sexual Health Day was launched in 2010 by the World Association for sexual health (WAS). It aims to promote sexual health, well-being and rights for all.
We are happy to do our part for sexual health by providing education in our field. Our goal is to fight cervical cancer with accurate and early diagnostics.

 

Photo: melitas

 

GynTect receives approval in China

Jena, August 25, 2022 – The cervical cancer screening test GynTect is now available to physicians and patients in China, the world’s most populous country. The product is the first approved methylation test for triage of HPV-positive cases in China. GynTect was developed by oncgnostics GmbH and is already approved in Europe.

Since 2017, there has been a cooperation between oncgnostics GmbH and the Chinese partner GeneoDx, a subsidiary of the Sinopharm Group. The GynTect clarification test has now been approved by the Chinese National Medical Products Administration (NMPA). An important prerequisite for this approval was a large-scale, multi-year study involving approximately 10,000 participants. The highly successful performance of GynTect in this study could again be demonstrated.

“Our China partners have done a remarkable job with their elaborate study. The subsequent approval for the Chinese market is an important milestone for both our partner and our company. The starting signal for sales in China has thus been given,” states Dr. Alfred Hansel, Managing Director of oncgnostics GmbH.

How GynTect works

The molecular biological test GynTect developed by oncgnostics clarifies early on whether a patient with an abnormal finding after undergoing cervical cancer screening has a predisposition for or already has cervical carcinoma (cervical cancer), resulting in the need for prompt treatment.

This screening test detects epigenetic changes, so-called methylations. Merely a cervical smear, also obtained for thin-layer cytology or HPV testing, is needed to perform this test. GynTect has a high sensitivity rate – to this date all cancer cases have been detected in studies in which it is used. In addition, the test has a very high specificity rate: very few women with inconspicuous findings are GynTect-positive. This positive aspect has been reconfirmed by the Chinese approval study.

GeneoDx distributes GynTect in China under exclusive license

“We are pleased to announce that GeneoDx has received approval for GynTect, the first DNA methylation-based cervical cancer screening diagnostic in China. This is a huge milestone for GeneoDx, but also for all Chinese women now having access to such an innovative product!” said Xiaokai Xia, Managing Director of Shanghai GeneoDx.

China is home to more than 400 million women between the ages of 25 and 64, all of whom are at risk of developing cervical cancer. More than 100,000 new cancer cases and nearly 60,000 deaths are reported here annually. GynTect’s approval means it can now be used in women 30 years and older who are infected with high-risk, cancer-causing HPV types. Screening studies showed that approximately 17% of women in China are infected with one of these types of high-risk HPV. This equates to about 70 million female patients who need screening. However, only few women with a HPV infection actually develop cervical cancer. It is precisely these cases that the GynTect test is designed to detect.

Advantages of GynTect

GynTect provides fast and reliable test results, giving affected women the certainty they need in order to effectively proceed with needed care upon receiving an abnormal screening result. Risk assessment is greatly facilitated due to the avoidance of unnecessary premature surgery and the increased chances of determining successful therapeutic measures. According to GeneoDx, the number of colposcopy referrals can be reduced by more than 60% when using GynTect.

In addition to numerous EU countries and the People’s Republic of China, GynTect is already being marketed in Brazil and Mexico. The oncgnostics GmbH is continually working to establish further suitable distribution partnerships with other countries worldwide.

About oncgnostics GmbH:

The Jena-based company oncgnostics GmbH specializes in the early detection of cancer. Its tests detect changes characteristic of cancer cell DNA. Founded in 2012, the company launched the GynTect test for cervical cancer diagnostics in 2015. oncgnostics GmbH is also conducting research into other cancer-type screening tests. For detailed information, please visit our website www.oncgnostics.com.

About GeneoDx and the SINOPHARM Group

GeneoDx is a subsidiary of Sinopharm Group (China National Pharmaceutical Group Co Ltd.). As one of the country’s leading healthcare companies, Sinopharm has built a nationwide logistics and distribution network for pharmaceuticals, medical devices and equipment. Starting from research and development, manufacturing, distribution, technical and financial services, the Group covers the whole range of the industry.

 

 Contact:
oncgnostics GmbH
Löbstedter Str. 41
07749 Jena
Germany
Tel.: 03641/5548550

pr(at)oncgnostics.com
www.oncgnostics.com