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.