The oncgnostics GmbH has taken on board the international firm Greiner Bio-One GmbH as a sales and marketing partner for its new screening test for cervical cancer. With CE approval issued for GynTect® in October of this year, the test is now approved for use in laboratories throughout Europe. The test is also expected to be certified for additional markets, for example in the USA.
Oncgnostics was founded in 2012 as a spinoff from the Department of Gynecology at the University of Jena with the aim of developing highly reliable biomolecular tests for cancer diagnostics based on patented epigenetic markers. At the beginning of October, GynTect became the first new diagnostic follow-up test developed by oncgnostics GmbH to obtain the CE-IVD label for the EU and other nations.
Rapid and reliable results
In developing GynTect, oncgnostics created a biomolecular test that provides early clarification of whether a cervical disease with the potential to proceed to cancer is actually present or developing in a woman with an abnormal Pap smear or documented human papillomavirus (HPV) infection. The test returns rapid and reliable results, thereby permitting rapid and reliable identification of those women with diseases requiring therapy. The availability of this test significantly improves risk assessment in cervical cancer screening: it helps to prevent unnecessary and premature surgery while increasing the chances of early and successful therapeutic intervention.
Distribution by an expert and established partner
To facilitate distribution of the test on the international market, oncgnostics will collaborate with Greiner Bio-One GmbH, starting immediately. The firm is already well known to many laboratories as a supplier and partner and has a long-standing presence in the field of early cervical cancer detection with its own HPV test PapilloCheck®. As a follow-up diagnostic test for women who have tested positive for HPV, GynTect will also serve as a follow-up test for PapilloCheck®. Further, in view of the pending new 2016 guidelines for cervical cancer screening in Germany and in other countries, which approve HPV testing as a primary screening option, the HPV testing market is becoming highly competitive. “With GynTect, we can further strengthen and expand our position in the diagnostic testing field. oncgnostics has precisely the right product to do this,” explains Dr. Ron Opstelten, Managing Director at Greiner Bio-One Diagnostics GmbH. In addition to Germany, the test is also marketed through Greiner Bio-One Diagnostics GmbH in Austria, Switzerland, France, England, and the BeNeLux countries.
World premiere for an international audience at the MEDICA 2015 Trade Fair
From 16th to 19th November, oncgnostics will be represented by an expert team at Booth G22 in Hall 15 at the MEDICA Trade Fair. On this occasion, GynTect will be presented to a large professional audience for the first time. The representatives who will be onsite and conducting press interviews are the two Managing Directors, Dr. Martina Schmitz and Dr. Alfred Hansel.
About Greiner Bio-One GmbH
Greiner Bio-One specializes in the development, production and distribution of high-quality products for the laboratory market made from synthetic materials. The firm is a technology partner for hospitals, laboratories, universities, research institutes, the diagnostic products and pharmaceutical industry, and biotechnology. Greiner Bio-One is divided into four lines of business: Pre-analytics, BioScience, Diagnostics, and OEM. The Greiner Bio-One Diagnostics Division develops, produces and markets products for human diagnostics, biopharmaceutical production, the food sector, and OEM products for the specialty areas of dental and veterinary medicine. Its two product families “oCHeck” and “Genspeed” meet the requirements for mass analyses (high throughput) as well as for individual analyses in acute diagnostics. Its test procedures are used to monitor vaccine safety and to detect sexually transmitted diseases and hospital pathogens, among others. In addition to its head office in Rainbach (Austria), the company’s sales and marketing headquarters are located in Frickenhausen (Germany).
About oncgnostics GmbH:
oncgnostics GmbH is a spin-off from the university women’s hospital Jena and was founded early in 2012. As a molecular diagnostic company oncgnostics is specialized on cancer diagnostics. Oncgnostics tests target epigenetic changes, so-called DNA methylations, that typically occur in cancer cells. The patented biomarkers which are evaluated using a specific algorithm are the core of the products and provide thus the basis for the company’s activities. Prominent investors have already invested into the market potential of the biotech startup, thus enabling the spin-off of the company and the development of the first product (High-Tech-Gründerfonds, Stiftung für Technologie, Innovation und Forschung Thüringen, bm-t Beteiligungsmanagement Thüringen GmbH and further investors).
Further information concerning cervical cancer screening:
Currently, cervical cancer screening is mainly performed by examining a smear from the portio and cervix uteri by microscopy (Pap smear). This Pap smear shows if cellular changes are present in the material. Testing for HPV shows if a patient is infected with high-risk human papillomavirus (HPV). But only a small number of HPV infections may lead to cervical cancer. In Germany, ca 90,000 so-called conizations, during which cervical tissue is removed by surgery are performed annually, based on Pap smear and further examination results with almost half of these surgeries being unnecessary. Exact triage tests are required in order to determine if a precancerous lesion or even cancer demanding treatment is present in case of an abnormal Pap smear. GynTect® may simplify these processes for gynaecologists and patients drastically. With unequivocal results GynTect® leads to a fast and reliable identification of women with a disease requiring therapy.
Dr. Alfred Hansel (CEO)
Winzerlaer Str. 2 - 07745 Jena (Germany)
P: +49 3641 508456
P: +49 3641 87611-80 / E: oncgnostics[.]tower-pr.com.