Oncgnostics will discuss new clinical data with gynaecological key opinion leaders at EUROGIN 2018

SAN FRANCISCO, CA, USA, November 29, 2018 — Oncgnostics GmbH presents new clinical data on GynTect® Precision Diagnostics for triage of unclear cervical cancer screening tests.

Oncgnostics GmbH, a Jena/Germany based company, has developed GynTect® for precision detection of cervical cancer. GynTect® was tested and validated in clinical trials on more than 3,000 samples with a remarkable detection score of 100% in all cervical cancer cases. Moreover, GynTect® identifies all relevant pre-cancerous lesions due to its first-of-a-kind prognostic value.

“We have concluded further clinical trials on the performance of GynTect® in comparison to alternative cervical cancer triage approaches. These results are very convincing and we are happy to present them in 5 talks at the EUROGIN 2018 conference in Lisbon next week”, states Dr. Alfred Hansel, Oncgnostics Chief Executive Officer.

Together with CSO Dr. Martina Schmitz and three Oncgnostics R&D specialists for cervical cancer and head-and-neck cancer diagnostics, Oncgnostics will discuss the new clinical data with gynecological key opinion leaders at Oncgnostics booth for precision cancer diagnostics.

Oncgnostics technology has been exclusively licensed out in 2017 to Sinopharm Group for the greater China region.

Biotech Alliances International Inc., a Silicon Valley-based healthcare-focused investment bank, is serving as the lead investment banker to Oncgnostics globalization and partnering strategy. Meetings with Oncgnostics Management Team can be coordinated at EUROGIN 2018 or JPM2019.

 

About Oncgnostics GmbH

Oncgnostics GmbH, founded in early 2012 as a spin-off from the Jena University women’s hospital, is a molecular diagnostics company specializing in 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 the basis for the company’s activities.

About Biotech Alliances International Inc.

Biotech Alliances International Inc. is a San Francisco-based investment bank serving life sciences companies, private equity, and venture capital funds. It provides independent financial and strategic advice including corporate finance, mergers & acquisitions, partnering & licensing, and strategic consulting.

Dr. Franck Brinkhaus
Biotech Alliances International Inc
+1 650-868-8511

The oncgnostics managers together with Geneo Dx managers and colleagues.

Dr. Martina Schmitz and Dr. Alfred Hansel, our CSO and CEO, have just come back from a visit in China, with days full of exciting events, dates and a few hours for sightseeing.

Shanghai at night

Shanghai at night

 

 

 

 

 

 

 

 

Shenzhen – Finals of the “Innovation & Entrepreneurship International Convention (IEIC)”

Having reached a second place at the European finals in Berlin, we were invited to participate in the IEIC Shenzhen. There, Alfred Hansel had the opportunity to present oncgnostics, to visit several science and technology parks and incubators, and to discuss cooperation options.

Shanghai – China International Medical Equipment Fair (CMEF)

Whereas Alfred Hansel visited Shenzhen, Martina Schmitz attended the international tradefair for medical technology CMEF in Shanghai. More than 4,000 exhibitors showed their latest developments and newest products to ca. 500,000 visitors. The chinese oncgnostics partner GeneoDx also had a booth – and presented our test GynTect!

CMEF

Luxiang Cheng, Business Development Manager at GeneoDx, and Dr. Martina Schmitz in front of the GynTect Roll-Up

 

 

 

 

 

 

 

 

 

Visit at GeneoDx

Finally, Martina Schmitz and Alfred Hansel visited our license partner GeneoDx. The contract for the exclusive cooperation concerning GynTect was signed a year ago, when GeneoDx still had its old name CJMT. Along with the renaming, GeneoDx moved to new facilities in Shanghai.

In the new facilities, GeneoDx has established the production of GynTect, and the CFDA has approved this production. Now GeneoDx will have to perform trials that are required in order to get final approval for the test. We discussed the trial design, in order to help GeneoDx design a trial protocol that may be discussed with the authorities. We also discussed options for further cooperation beyond GynTect.

„We could spend a lot of time with our partners at GeneoDx, and we were glad to meet some of the people again whom we had shown how to produce and how to perform GynTect last year in our labs. It was exciting to visit their new research labs as well as the GynTect production facility“, Martina Schmitz said.

The oncgnostics managers were then invited to get a taste of the typical Chinese cuisine, before they took their way back to Germany after some really exciting days.

Traditional Chinese Meal with the Colleagues from Geneo Dx.

Traditional Chinese Meal with the Colleagues from Geneo Dx.

Portugal Partnership

Lisbon/Jena, April 16th 2018 – Speculum S.A. is the exclusive licence partner of oncgnostics GmbH for the screening test GynTect® in Portugal. The test is designed to further specify abnormal results in screening examinations and to help determine the best treatment approach.

 

In January, the biotech firm oncgnostics GmbH from Jena (Germany), concluded an exclusive sales partnership for the GynTect screening test in Slovakia and the Czech Republic. Now, Speculum S.A. in Portugal has become the newest sales partner to obtain an exclusive licence. As a result, Portugal becomes the fourth European country where GynTect will be offered.

 

Speculum S.A. is well positioned in Portugal

The Team of Speculum S.A. in Portugal

The Team of Speculum S.A. in Portugal. Source: Speculum S.A.

 

 

 

 

 

Speculum S.A. sells a range of medical devices focused on gynaecology. The firm is very extensively networked with professionals and leading figures in the area of women’s health. In addition, LAP Porto, the largest Portuguese diagnostic laboratory in the area of women’s health, cooperates with Speculum S.A.

Moreover, the company was mainly involved in the introduction of thin-layer cytology, an improved Pap smear method, which now has over 50% of the market share in Portugal. Since GynTect can be performed based on these improved Pap smears, the prospects are very good for the market introduction in Portugal.

 

GynTect provides rapid and reliable results

GynTect, the molecular biology test developed by oncgnostics, offers an early diagnosis for patients with abnormal Pap test results or evidence of human papillomavirus infection (HPV) to determine the presence of a treatable cervical cancer precursor and the likelihood of developing cervical carcinoma. The test provides rapid and reliable results and gives affected women certain guidance about how to proceed in the face of an abnormal prior examination in the best way. GynTect substantially simplifies risk assessment in the early detection of cervical cancer: on the one hand, it helps to avoid unnecessary premature surgery, and on the other hand, it can increase the chances for successful therapeutic interventions.

 

High death rates for cervical cancer in Portugal

The morbidity rate for cervical cancer in Portugal is higher than in Germany. In Portugal, 9 of 100,000 women develop the disease, compared to 8.2 per 100,000 in Germany. In Portugal, cervical cancer is the second-most common form of cancer among women between ages 15 and 44 years, whereas in Germany, the frequency of occurrence for women of this age puts is in 3rd place. However, the difference in death rates is far greater: in Portugal, 54% of all patients with cervical cancer die of the disease, whereas in Germany, the rate is about one out of three.

“By means of early recognition of cervical cancer, effective treatment can be performed and further complications can be prevented. With GynTect, we are counting on an effective measure in the fight against cervical cancer and its sequelae”, states Antonio Ferreira, Managing Director of Speculum S.A. in Lisbon.

 

Further partnerships planned

Europe-wide CE-IVD licensing for GynTect took place in 2015, opening the way to European partnerships. In the past year, oncgnostics also concluded an exclusive licensing agreement for the Chinese market with GeneoDx, a subsidiary firm of the state-owned Sinopharm Group.

Further partnerships for the internationalisation of GynTect are in negotiation.

 

 

 

About oncgnostics GmbH:

The oncgnostics GmbH was developed in 2012 from a university research group at the Jena University Gynaecology Department. As a molecular diagnostics firm, the Jena start-up has specialised in the early diagnosis of cancer. The tests demonstrate characteristic epigenetic changes in the cancer cells, known as DNA methylations. The patented biomarkers identified with specific algorithms form the central core of the products and are the foundation of the firm.

 

 

Free pictures and download material for your distribution: bit.ly/2ymMw6H

More about GynTect and oncgnostics:

www.mynewsdesk.com/de/tower-pr/latest_media/tag/oncgnostics

and: www.oncgnostics.com/downloads

 

Medirex team in Bratislava

Jena, January 31th 2018 – oncgnostics GmbH partners with the MEDIREX Group. MEDIREX thus holds the exclusive rights for marketing the test for early and reliable detection of cervical cancer, GynTect®, for Slovakia and the Czech Republic.

 

Following their successful crowd-funding via the platform Seedmatch, oncgnostics GmbH takes the next step for internationalization: the company closed a partnership with the MEDIREX Group. The Slovak laboratory diagnostics group has more than 1700 employees, and is the biggest player in lab diagnostics, with >50% market share in the Slovak Republic. The contract has a term for three years, with option for extension.

 

GynTect gives certainty

The molecular test GynTect developed by oncgnostics helps to clarify early and reliably if a patient diagnosed with an abnormal Pap smear or/and with an HPV infection (already) has or develops a cervical precancerous lesion requiring treatment.

“With GynTect we intend to improve the quality of cervical cancer screening in the Czech and the Slovak Republic. GynTect provides fast and reliable diagnostic results and thus women who are affected, certainty how to proceed after abnormal findings from earlier diagnostic measures,“ Jozef Gavlas, CEO of MEDIREX Lab diagnostics states, said.

GynTect drastically improves the risk assessment in cervical cancer screening: on the one hand it allows to avoid hasty and unnecessary surgeries, on the other hand it increases the chance for early, successful treatment measures.

 

Cervical cancer in numbers: Germany, Czech Republic and Slovak Republic

In Germany, ca. 5000 women are diagnosed with cervical cancer every year. Thus 8.2 of 100,000 women get a diagnosis annually. In the Czech Republic and in Slovakia, the disease rates are much higher, at 14.1 and 16.1 of 100,000 women annually, respectively. In all three countries, every third woman with cancer diagnosis dies.

Regular participation of women in cervical cancer screening programs, which are offered in all three countries, may contribute to significantly reduce the morbidity. HPV-induced changes may be detected early, and appropriate measures may be taken. Nevertheless only ca. 50% of all women participate regularly in the annual screening in Germany and the Czech Republic. In Slovakia, where triennial cervical cancer screening is implemented, even less than 50% participate regularly.

 

Further partnerships are planned

GynTect already has CE IVD mark for use in laboratories Europe-wide. Thus, the MEDIREX group immediately may start distribution as well as the use of the test in its own labs. CE IVD mark was received in 2015. In 2017, oncgnostics was able to close an exclusive license agreement for marketing in China with GeneoDx, an affiliate of the governmental Sinopharm Group.

Further partnerships within and outside of Europe are currently negotiated, with the aim to conclude agreements in 2018. The crowd-funding campaign, which very recently was concluded successfully, provided oncgnostics with 750,000 €, which significantly will contribute to plan, negotiate and close further agreements.

 

About oncgnostics

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, the 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 the basis for the company’s activities.

 

 

Contact:

oncgnostics GmbH

Dr. Alfred Hansel

Geschäftsführer

Winzerlaer Str. 2 (Bioinstrumentezentrum)

DE-07745 Jena

Tel. +49 3641 508456

pr@oncgnostics.com

www.oncgnostics.com

 

Media Agentur

Tower PR

Mälzerstraße 3

07745 Jena

Tel. +49 3641 87611-80

oncgnostics@tower-pr.com

www.tower-pr.com

Dr. Xia Xiaokai and Dr. Alfred Hansel, chairman of oncgnostics GmbH. In the background: Yang Xiaoming, chairman of CNBG, Wolfgang Tiefensee, Thuringia's Minister for economics, Dr. Michael Brandkamp, chairman of the High-Tech-Gründerfonds sowie Peter Haug, oncgnostics. photo: Christoph Worsch

Jena, April 5th, 2017: The Chinese pharma company Changchun Jienuo Medical Technology (CJMT), a subsidiary of the Chinese state-owned SINOPHARM Group (www.sinopharm.com/en), has purchased an exclusive license from oncgnostics (www.oncgnostics.com) for marketing GynTect® in China, Hongkong and Macao. The contract comprising four milestones rules the approval of GynTect® at the Chinese Food and Drug Agency (CFDA) within the coming three years. Oncgnostics will receive upfront and milestone payments as well as royalties on future revenues.

 

During a visit of the Chinese partner in the science city Jena the contracts were signed in the presence of the Chairman of the Sinopharm Group, Mr. Jianxin Guo, and of Thuringia’s Minister for Economics, Science and Digital Society, Mr. Wolfgang Tiefensee. “oncgnostics constitutes an exciting example how research in Jena is the basis of a promising business model. The cooperation with the Chinese partner which includes the distribution of the triage test GynTect, is the right and important step for the internationalization of the enterprise and the exploration of the by far largest patient market. This case shows that it is worth to support substantial innovative foundings, which are a main focus of our economic policy”, Wolfgang Tiefensee explained during the signing ceremony.

 

The molecular diagnostic test GynTect (https://www.oncgnostics.com/gyntect-cervical-cancer/?lang=en) clarifies timely if a patient with abnormal Pap smear and/or positive HPV test result develops or already has a cervical cancer requiring treatment. GynTect provides fast and reliable results and thus certainty for women affected. Therefore, risk assessment in cervical cancer screening is significantly improved: on the one hand hasty and unnecessary surgeries can be avoided, on the other hand the chances for obtaining a successful treatment can be improved.

 

GynTect has received CE IVD mark for the EU market already in 2015. Together with its clinical partner at the University women’s hospital in Jena, oncgnostics has driven forward validation of the markers, development of the test format and CE IVD mark of GynTect, using more than 2,000 clinically well-characterized samples. Together with its new partner CJMT oncgnostics intends to enter the enormous market in China. Cervical cancer diagnostics based on HPV screening yields a market potential of >1 bn €.

 

In China, more than 550 million women aged >15 years are at risk of developing cervical cancer. “China has a very high demand for screening and triage tests. GynTect will help us to diagnose cervical cancer and its precancerous stages reliably, in order to prevent unnecessary surgeries and to detect malignant tissue alterations early,” Dr. Xiaokai Xia, director of the Chinese partner CJMT stated.

 

CJMT, a subsidiary of the China National Biotech Group (CNBG; http://en.cnbg.com.cn/html/about/show_1.html), is specialized on clinical diagnostics. Both companies belong to the governmentally held SINOPHARM group (www.sinopharm.com/en), which with more than 100,000 employees and more than $40 bn annual turnover constitutes one of the largest pharma companies world-wide.

 

The exclusive license contract was signed on 5th of April 2017 at the BioInstrumentation center in a top-class event. Wolfgang Tiefensee, Thuringia’s Minister for Economics, Science and Digital Society, welcomed the Chinese delegation comprising of 13 representatives. With Jianxin Guo, Chairman of the Sinopharm Group, Shengyi Shi, Vice President of Sinopharm Group and Xiaoming Yang, Chairman of CNBG, the top-level management of Sinopharm visited Jena. Besides the founders and the management of oncgnostics GmbH, the lead investors of the first two financing rounds High-Tech Gruenderfonds and beteiligungsmanagement thueringen GmbH, represented by their CEOs, Dr. Michael Brandkamp and Udo Werner, respectively, joined the signing ceremony.

 

About GynTect

In Germany 5000 new cases of cervical cancer are diagnosed, and approx.1600 women die from the disease annually. On the other hand, more than 200,000 women receive an abnormal result in the Pap smear diagnosis, the current cervical cancer screening method. Only a minority of these women, however, have a disease requiring treatment, as most of the diagnosed cervical dysplasias (cellular changes) will heal spontaneously. The early detection test GynTect yields fast and reliable results and thus certainty after an abnormal Pap smear and/or a positive HPV test result. GynTect may be performed on residual material from a cervical smear taken for liquid-based cytology. GynTect detects cancer cases with a sensitivity of 100% – all cancer cases included in studies so far yielded a positive GynTect result. The test is based on biomarkers that are present in cervical carcinomas as well as cervical dysplasias that develop into cancer.

 

About oncgnostics

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.

 

About Sinopharm Inc. and CJMT

China National Pharmaceutical Group Corp. (CNPGC) known as Sinopharm is a Chinese state-owned enterprise. In 2015, Sinopharm Group had 104.464 employees, annual sales of more than $44bn and was ranked 205 in the global Fortune500 list (http://beta.fortune.com/global500/sinopharm-205).

Jena, November 9th, 2016 – The biotech company oncgnostics (www.oncgnostics.com) will present its new version of the triage test GynTect – a test for the fast and reliable detection of cervical cancer – at the world-leading trade fair Medica. Between 14th and 17th of November 2016 the epigenetics experts will explain the advantages of the test compared to the methods currently available in cervical cancer early detection as well as the new features of the extended GynTect version. The company will also provide information at its booth concerning the current status of its pipeline projects in ovarian as well as head-and-neck cancer diagnostics.

After its successful regulatory approval with CE IVD mark in autumn 2015 oncgnostics continuously refined its cervical cancer triage test GynTect. This new version allows for a much broader range of applications in gynecologic practices and laboratories. GynTect may now be performed directly from a widely used cervical smear medium (PreservCyt, Hologic). This medium allows for both, an advanced form of the microscopic cervical smear examination, the so-called ThinPrep cytology (a version of the Pap test), as well as for HPV tests using the methods developed by different companies. For the first GynTect version a separate cervical smear was required, whereas the new test may now be performed using an already available thin-layer cytology sample. Thus, GynTect also corresponds to the provisions of new guidelines which claim that triage tests in cervical cancer diagnostics need to be performed from the same sample as the initial screening test.

With GynTect oncgnostics has developed a molecular diagnostic test which clarifies early and reliably if a patient with abnormal Pap smear and/or a high-risk HPV infection has a cervical precancerous lesion or cancer that requires treatment. The diagnostic procedure is based on the detection of epigenetic changes in cells of a cervical smear. The emergence of specific epigenetic markers indicates that a precancerous lesion or a carcinoma may be present. Thus, GynTect provides secure test results, which improve the risk assessment in cervical cancer screening: on one hand, unnecessary and hasty surgeries may be avoided; on the other hand true signs of cervical cancer and its preliminary stages may be identified timely. This improves the prospects for early and successful therapeutic measures drastically.

With a team of experts oncgnostics exhibits at the Medica from 14th to 17th of November 2016 at booth E21 in hall 15, a joint stand organized by medways e.V., Jena. On this occasion, the new GynTect will be presented to a large professional audience for the first time. Expert contacts on site are the two managing directors, Dr. Martina Schmitz and Dr. Alfred Hansel. Upon interest in a press interview, please contact us in advance using pr@oncgnostics.com

Medica is THE leading international trade fair and congress for medical technology, electrical medicine, lab equipment, diagnostics and medicines. Ca. 4800 exhibitors from more than 70 countries utilize the Medica as the leading fair for presenting new products and services.

GynTect® is a registered trademark owned by oncgnostics GmbH.

Links:

Find cost-free picture material concerning this press release, the test and the company here:http://oncgnostics.com/downloads

Those who have once been suspected to suffer from a severe disease know all-too-well, how long and grueling it can be to wait for further examinations that might bring clarity. These days, weeks and months are often very stressful for the person affected – and seemingly endless.
In the course of cervical cancer screening, an abnormal Pap smear or a positive test result for human Papillomaviruses (the viruses causing the cancer) should not directly lead to a surgical treatment, a so-called conisation: in fact, many of the cervical tissue changes observed by these tests, which appear like precancerous lesions, may heal by themselves. Many of these surgeries are, however, performed often too fast and unnecessary, since they are based on such results, without a clear diagnostic proof for the malignancy of the lesion.

It is therefore even more important that gynaecologists and patients can rely on tests which yield fast and accurate results, so hasty interventions or wrong therapies are avoided. With GynTect oncgnostics has developed a test that exactly meets these requirements. With GynTect, patients with an abnormal finding receive a fast and reliable proof, if tissue lesions at the Cervix uteri may progress to cancer and thus require treatment.

With the crowd-investing campaign starting today on seedmatch.de/oncgnostics we intend to raise capital for finalizing the development of an advanced GynTect, with which we want to avoid unnecessary surgeries as well as further follow-up tests, distress and uncertainty for women. In this connection we also want to proceed with distribution and internationalization of the test, in order to make it accessible for further markets.

Why crowd-investing?

oncgnostics Team

oncgnostics Team

In contrast to our first financing rounds in 2012 and 2014, which allowed the founding of oncgnostics as well as the full development of GynTect with its CE mark, establishment of its production and the first steps in marketing, we choose a different financing option. We deliberately opted for a crowd-investing campaign, since with this option small investors will have the opportunity to make a big investment into health and life – and thus help many patients. GynTect is not an every-day gadget, but a molecular diagnostic test which allows early detection and thus early treatment of cancer.

Seedmatch is the suitable platform for this task: as of August 4th, 2016, everybody who wants to support our work, may become part of our “crowd” as an investor. With a minimum investment of 250 € participation in the success of our product GynTect and our company is possible. Depending upon the progress of our company and our product portfolio, investors may have the chance for an attractive yield. The campaign runs for 60 days and allows insight into our investment story and our business plan for potential investors interested in our concept. You find the campaign here: seedmatch.de/oncgnostics

What makes our crowd-investing campaign so exceptional?

Crowd-investing has become an attractive financing option. Many companies in start-up or even later phase use this option in order to be able to realize new ideas or products. Our campaign has some peculiarities. Firstly, our current investor bm|t Beteiligungsmanagement Thüringen GmbH, intends to co-invest and to double each Euro invested by the crowd, through its Startup Funds. Thus, an investment of 250 € by a crowd investor means a total of 500 € for oncgnostics.

“We invest into oncgnostics again, because we believe in the team, the technology, as well as the very good market opportunities of GynTect”, Udo Werner, CEO of bm|t points out. Secondly we are proud that we get prominent support! Andrea Henkel, former Olympics and multiple world champion in biathlon is brand ambassador for GynTect. She supports us in raising awareness of GynTect and in promoting medical information concerning cervical cancer, screening, and the examination methods used in screening and triage.

“In is of prime importance that women regularly attend their gynaecologist for participating in cancer screening programs. Many of them, however, do not even know what in particular is to be examined and what an abnormal test result means. Therefore, I support oncgnostics during their campaign and their efforts to raise public awareness for the topic cervical cancer and their test GynTect®!”

Prominent support: Former German biathlete Andrea Henkel

Prominente Unterstützung bei der Kampage: Andrea Henkel

With annually 530,000 new cases, cervical cancer is still the 3rd most frequent cancer in women worldwide; more that half of the cases still are fatal. Therefore it is even more important that women attend cancer screening. Even women vaccinated against HPV should, despite their higher protection against infection should attend screening, since vaccination only protects against the two out of twelve HPV types that most frequently evoke cervical cancer. A new vaccine, which is available now, protects already against seven of the 12 types – but still does not cause full immunity.

Please find further information on our Seedmatch campaign here: seedmatch.de/oncgnostics

As a result of the risks that are associated, an investment in this form is suitable only for investors who can accept a total loss of invested funds.

Warning: This investment carries considerable risks and may lead to a complete loss of the capital invested.