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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About oncgnostics

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.

About GynTect

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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Contacts

oncg­nos­tics GmbH
Ines Sommer
Com­mu­ni­ca­tion and Marketing
Winz­er­laer Str. 2 (Bioin­stru­ment Centre)
07745 Jena
Phone +49 3641 55485–00
ines.sommer@oncgnostics.com
www.oncgnostics.com

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Miriam Mathias
Mälz­er­strasse 3
07745 Jena
Tel. +49 3641 87611–80
oncgnostics@tower-pr.com
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