Approval for cervical cancer screening test in the Chinese market expected in early 2020 / First contacts in Japan
Shanghai/Yokohama/Tokyo/Jena, 1 November 2019 –Our business partner in China, GeneoDx, is about to get approval to commercialise GynTect in the Chinese market. This issue was discussed at a business meeting with representatives from oncgnostics GmbH in Shanghai.
Our Chinese business partner GeneoDx, a SINOPHARM subsidiary, presented oncgnostics’ managing directors, Dr Martina Schmitz and Dr Alfred Hansel, in Shanghai with the results of their recently completed approval study for the National Medical Products Administration (NMPA) for the molecular biological test GynTect. The approval of GynTect for the Chinese market is expected in early 2020. The test allows reliable and rapid diagnosis of cervical cancer and its precancerous stages.
‘Our partners have conducted a study with approximately 1,300 samples. Results look very promising. We are optimistic that GeneoDx will receive approval for GynTect without any problems. Moreover, the study will be followed by high-ranking publications,’ states oncgnostics’ managing director Martina Schmitz.
Dr Alfred Hansel visited BioJapan in Yokohama, Japan. At the conference, he cultivated existing contacts, which he had made during a visit to MedTech Japan in Tokyo earlier this year. He also held discussions with other companies on the marketing opportunities of GynTect in Japan and other countries in Southeast Asia.
The Asian market is interesting for oncgnostics not only with regard to GynTect. International partnerships are also being sought for current pipeline projects, in particular the development of assays in the field of head and neck tumour diagnostics.
Jena’s oncgnostics GmbH specialises in the early detection of cancer. Its tests detect changes that are characteristic of cancer cells’ DNA. Founded in 2012, the company launched GynTect in 2015. As part of its programme for the early detection of cervical cancer, the test clarifies whether cervical cancer or precancerous lesions are already present. In April 2017, GeneoDx and oncgnostics signed an exclusive license agreement for GynTect in China, Hong Kong, and Macau.
Oncgnostics GmbH is also conducting research into tests for the clarification of other types of cancer. Detailed information is available at www.oncgnostics.com.
GynTect is a molecular biological test that identifies six areas of the human genome that are methylated only during the development of cancer cells. Thus, GynTect recognises malignant changes in patients.