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Faster and more reliable results in cancer diagnostics: Molecular biological test for cervical cancer “GynTect” receives CE market approval

  • 2015

Biotech com­pany oncg­nos­tics GmbH has received CE-IVD approval to mar­ket the “Gyn­Tect” test for the detec­tion of cer­vi­cal can­cer and its pre­cur­sors. The test, based on cel­lu­lar epi­ge­netic bio­mark­ers, deliv­ers test results quickly and reli­ably, thus enabling cases of can­cer to be iden­ti­fied faster and improve ther­a­peu­tic suc­cess. The test greatly sim­pli­fies the risk assess­ment por­tion of cer­vi­cal can­cer screen­ing and there­fore can reduce unnec­es­sary oper­a­tions. Gyn­Tect is ready to be intro­duced imme­di­ately through­out EU lab­o­ra­to­ries and clinics.

Europe-wide mar­ket­ing autho­riza­tion with the CE-IVD label­ing has now been granted for Gyn­Tect. oncg­nos­tics will begin the mar­ket launch of the patented test to other Euro­pean coun­tries beyond Ger­many in the com­ing months. The mar­ket launch in North Amer­ica and Asia is in the works.

Cer­vi­cal can­cer is almost always cur­able in its early stages.

Unlike other screen­ing meth­ods, Gyn­Tect deliv­ers results that give a defin­i­tive answer about can­cer risk. Even the first pre­cur­sors can be iden­ti­fied by this diag­nos­tic method, enabling a quick treat­ment deci­sion. Gyn­Tect uses the same sam­ple used for the Pap smear or HPV test, thereby mak­ing an addi­tional cell col­lec­tion from the patient unnec­es­sary. Gyn­Tect pro­vides rapid and reli­able clar­i­fi­ca­tion to patients with ambigu­ous Pap and HPV find­ings and helps to avoid unnec­es­sary treat­ments, as not every infec­tion auto­mat­i­cally leads to can­cer. Sur­gi­cal pro­ce­dures are not nec­es­sary in women who are infected with HPV but exhibit no can­cer cells.

Almost every woman expe­ri­ences an HPV infec­tion dur­ing her life, but only a few cases will develop into cer­vi­cal can­cer. It is still the third most com­mon can­cer in women world­wide, with approx­i­mately 530,000 new cases per year and more than half of these prov­ing fatal. Each year, there are 55,000 new cases reported in Europe, 4,500 of which occur in Ger­many (World Health Orga­ni­za­tion, 2010). In my eyes, Gyn­Tect is a break­through in screen­ing and can help to reduce this num­ber,” said Prof. Dr. Matthias Dürst, Virol­o­gist and Head of the Gynae­co­logic Mol­e­c­u­lar Biol­ogy func­tional unit at the Jena Uni­ver­sity Hospital’s Women’s Clinic.

About oncg­nos­tics

A spin-off of Jena Uni­ver­sity Hospital’s Women’s Clinic, oncg­nos­tics focuses on in vitro diag­nos­tic tests for the early and accu­rate detec­tion of can­cer uti­liz­ing pro­pri­etary epi­ge­netic bio­mark­ers. The diag­nos­tic prod­ucts allow ear­lier detec­tion of more can­cer cases and thus con­tribute to the improve­ment of ther­a­peu­tic suc­cess. The ini­tial prod­uct devel­oped, Gyn­Tect®, allows the rapid and reli­able detec­tion of cer­vi­cal pre­can­cer­ous lesions and cancer.

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