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 DNA 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 its 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 was again proven.
“Our partners in China have done a remarkable job with their large study. The subsequent approval for the Chinese market is an important milestone for both our partner and our company. All prerequisites for sales in China have thus been achieved,” states Dr. Alfred Hansel, Managing Director of oncgnostics GmbH.
How GynTect works
The molecular biological test GynTect developed by oncgnostics clarifies early 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 a small percentage of 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 appropriately 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. oncgnostics GmbH continues to establish further suitable distribution partnerships with other countries worldwide.
“This is another success for our bm|t portfolio and again demonstrates the world-class level of the life science cluster in Jena. We are particularly pleased that oncgnostics is already in advanced discussions with additional partners for approval in the US.” Says Michael Thiele, Investment Manager of bm|t.
About oncgnostics GmbH:
Jena-based 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 Ldt.). 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. Sinopharm is ranked 80 in the global fortune list, has more than 120 000 employees and revenues of 103.2 Mrd Euro in 2021.