The cervical cancer diagnostics test GynTect is now available to physicians and patients in 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.