Approval for cervical cancer screening test for the Chinese market expected in early 2020 / First contacts in Japan
The Chinese partner company GeneoDx, a SINOPHARM subsidiary, presented the results of its recently completed approval study for the National Medical Products Administration (NMPA) for the molecular biological test GynTect to oncgnostics’ managing directors Dr Martina Schmitz and Dr Alfred Hansel in Shanghai. The approval of GynTect for the Chinese market is expected in early 2020. The test allows the reliable and rapid diagnosis of cervical cancer (cervical carcinoma) and its precursors.
“Our partners have conducted a study with around 1,300 samples. The results look very promising. We are optimistic that GeneoDx will receive marketing approval for GynTect without any problems. In addition, high-level publications will follow from the study,” says oncgnostics CEO Dr Martina Schmitz.
In Japan, Dr Alfred Hansel visited BioJapan in Yokohama from 9 to 11 October. At the conference, he cultivated existing contacts that he had made during a visit to MedTech Japan in Tokyo in the spring of this year. He also held talks with other companies about the marketing opportunities for GynTect in Japan and other countries in the Southeast Asia region.
The Asian market is not only interesting for oncgnostics with regard to GynTect. International partnerships are also being sought for the current pipeline projects, in particular the development of assays in the field of head and neck tumour diagnostics.
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Jena-based oncgnostics GmbH specialises in the early detection of cancer. Its tests detect changes that are characteristic of the DNA of cancer cells. The company, founded in 2012, launched GynTect in 2015. In the context of early cervical cancer detection, the test clarifies whether cervical cancer or precancerous lesions are already present. In April 2017, the two companies GeneoDx and oncgnostics signed an exclusive licensing agreement for GynTect in China, Hong Kong and Macao. oncgnostics GmbH is also researching clarification tests for other types of cancer. Detailed information is available at www.oncgnostics.com.
GynTect is a molecular biological test that detects six regions of the human genome that are only present in methylated form during the development of cancer cells. Thus, GynTect detects patients with malignant changes.
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