Tag Archive for: cervical cancer

Cancer prevention remains a matter of the heart: Biotech company oncgnostics celebrates 10th anniversary

team of oncgnostics celebrates 10th anniversary

The company oncgnostics GmbH, founded in 2012, already launched its first product in 2015: the diagnostic test for cervical cancer “GynTect”. This is now sold in over ten countries in Europe and Asia. In addition, oncgnostics conducts research in the field of diagnostics for head and neck cancer. The company is growing steadily and has around 20 employees, all of whom have remained loyal to the company to date.

 

The success story of oncgnostics GmbH began in February 2012. “We realized that we wanted to use our research results obtained at the University Women’s Hospital Jena beyond science. Cervical cancer screening was in urgent need of improvement – and we had a solution,” CEO Dr. Alfred Hansel describes the original idea. Thus, a small team around CEO Dr. Martina Schmitz and Dr. Alfred Hansel spun off from the Gynecological Molecular Biology Department of the University Hospital Jena (UKJ).

Detecting cancer with the help of biomarkers

Core expertise of the company are molecular biology markers that can be used to reliably detect cancer cells. These markers are bundled for specific tests. For example, in the case of abnormal gynecological findings, the GynTect test clarifies whether cervical cancer is developing or whether the abnormalities will heal on their own.

The company is also conducting research into the early detection of head and neck tumors. Unlike cervical cancer screening, there is still no regulated procedure for this disease. The Jena-based company is involved in the development of a test designed to detect cancers of the mouth and throat.

Oncgnostics’ overall goal is to improve cancer screening and prevent unnecessary cases. “Cervical cancer shouldn’t even exist anymore with today’s diagnostic and screening options,” said Dr. Martina Schmitz, CSO.

Important support from science and investors

“Without our investors and partners, we would not be where we are today. That is why we would like to express our thanks to everyone who has supported us over the past ten years,” adds Dr. Martina Schmitz. The company continues to be supported by the University Hospital Jena, other partners from the scientific community, and investors. Private investors as well as retail investors have also invested in the company in two very successful crowdinvesting campaigns.

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Looking back on a successful year of research

Theresa Erler im Labor der oncgnostics GmbHEberhard Schorr / oncgnostics GmbH

2020 was a challenging year – also for our company. Nevertheless, we look back on successful achievements.

GynTect® convinces in test comparison

In November, the journal Clinical Epigenetics published a comparative study on cervical cancer diagnostics tests. Two tests based on epigenetic markers, oncgnostics’ GynTect® and QIAGEN’s QIAsure, were tested on a selection of patient samples. Both tests may be used to identify clinically relevant, HPV-induced cervical disease that may develop into cancer. The aim of the study was to determine not only the sensitivity but also the specificity of the tests, which means how frequently a test delivers a false-positive result. Both tests demonstrated a very good sensitivity for high-grade lesions, especially for cancer cases. However, for GynTect®, the specificity was significantly higher, which means that the rate of false-positive results among healthy HPV-positive women was much lower. Thus, GynTect® may be preferable, due to its higher specificity for CIN2+ or CIN3+.

Achievements: active in research despite Corona

In August 2020, a study on psychological stress in connection to abnormalities found in cervical cancer screening was published, with our contribution. More than 3700 women participated in this scientifically supported online survey. Women with abnormal Pap smear findings or with an HPV infection stated, among other concerns, that they are worried about developing cancer. Even though neither an abnormal Pap smear finding nor an HPV infection does provide a reliable indication of cancer. Nearly half of those affected even expressed fears of dying from cervical cancer. The results were published in the journal Archives of Gynecology and Obstetrics.

Furthermore, we have made significant progress in the diagnostics of Head-and-Neck tumors: Since 2019, we have developed a test based on proprietary DNA methylation markers that may be used in Head-and-Neck cancer diagnostics. In 2020, the corresponding study “OncSaliva” started in the University Hospital Jena. Four more centers will be added by the end of the first quarter of 2021. A total of 150 patients provide saliva and blood samples at the time of their cancer surgery. In addition, we obtain tissue samples from the tumor for analysis. The samples are tested for the methylation markers. 150 healthy subjects are also included, from whom tissue and saliva samples are collected. During the subsequent post-surgical follow-up care, the patients enrolled in the study regularly provide saliva samples for recurrence detection for up to two years. Our scientists analyze the methylation markers in the saliva. This non-invasive method may enable a timely detection of recurrences in the follow-up. The study will run until the end of 2023.

Outlook for 2021: New cooperation and appearance at Eurogin

The results of the GynTect®-PRO study will be available in May. Our company started a three-year follow-up study with the GynTect® test procedure in 2017. For this trial, patients from ten study centers in Germany were enrolled. It is intended to show that young patients with a negative GynTect® result do not develop cervical cancer despite conspicuous changes observed at the cervix uteri. Instead, the cell changes heal by themselves.

In 2021, we will reach another milestone in our international sales activities. Our company recently negotiated a partnership with the international diagnostics group EUROIMMUN, a PerkinElmer company.

Save the Date: We will participate at the international, multidisciplinary HPV congress Eurogin from May 30th to June 1st 2021.

 

Picture: Pharmaceutical biotechnologist Theresa Erler in the oncgnostics laboratory / © Eberhard Schorr

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Early detection test GynTect® now available for Roche Diagnostics QPCR system

cobas Z480 Analyzer von Roche Diagnostics oncgnostics GmbH

Jena, 20. February, 2019 – The test for early detection of cervical cancer GynTect® may now also be performed on the cobas Z480 analyzer, a widely used quantitative PCR (QPCR) system from Roche Diagnostics. This is now possible through an extension of the GynTect® CE IVD mark (CE mark for in vitro diagnostics). The biotech company oncgnostics GmbH is developer and provider of GynTect®.

GynTect® allows a fast and reliable clarification, if a patient with abnormal Pap smear findings or an HPV infection, is about to develop or already has cervical cancer. GynTect® allows to detect modified, esp. methylated DNA regions. Methylation of these DNA regions specifically occurs in cervical cancer.

Performance of GynTect using the Cobas Z480
Two steps are required for the performance of GynTect®. In the first step a chemical treatment with bisulphite fixates the DNA methylation of the diagnostic material. For the detection of the marker regions a PCR (Polymerase Chain Reaction) is required. The cobas Z480 Analyzer by Roche Diagnostics allows the performance of such a diagnostic PCR. Based on the data obtained in the PCR, the GynTect® results are derived. Only originally methylated DNA regions present in the sample are amplified during the PCR. This procedure is termed methylation-specific PCR (MSP).

More laboratories may perform GynTect® now
“By now GynTect® could only be performed on the ABI7500 Real-Time PCR system from Life Technologies. Extension of the CE IVD mark now allows to run the test on the cobas Z480 PCR system as well. With its widespread availability many more laboratories now can perform GynTect® without any additional expenses”, Alfred Hansel, co-founder and CEO of oncgnostics said.

You may find free press material here:
www.oncgnostics.com/downloads
vimeo.com/243256803

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Oncgnostics GmbH Presents New Clinical Data on GynTect® Precision Diagnostics at EUROGIN 2018

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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

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Cervical Cancer Screening: oncgnostics Closes further Investment Round

Das oncgnostics-Teamoncgnostics GmbH

Jena, October 17, 2018 – The Thuringian molecular diagnostics company oncgnostics, which quickly and successfully closed a 750,000 Euros crowd-investing round on Seedmatch early in 2018, now announces the closing of another similarly sized round. oncgnostics has developed the cervical cancer diagnostics test GynTect®, and a private investor circle now invests together with the  current institutional investor beteiligungsmanagement thüringen (bm-t). The company will use the total investment for performing further clinical trials and for intensifying its international marketing efforts.

 

At the end of 2017, oncgnostics started a second campaign for its diagnostic test GynTect via the crowd-investing platform Seedmatch. It took only 2.5 hours until the funding reached the threshold of 100,000 EUR, and only three weeks to reach a total sum of 750,000EUR, making : it the fastest crowd-investing campaign for a life sciences company in Germany. Now this sum will be doubled by beteiligungsmanagement thüringen (bm-t), which is already a key shareholder at oncgnostics, and by a circle of private investors.

 

“oncgnostics´ GynTect test addresses a potential billion-dollar market. This investment will allow the company to build targeted sales and marketing efforts in order to better access and develop this attractive market. Additionally, the company has a compelling technology pipeline, which will be further advanced with this capital. We´re very pleased to join this investment round“, Kevin Reeder, CEO at bm-t, stated.

 

Better options for early diagnosis

GynTect clarifies early and reliably, if a patient is about to develop or even already has developed a cervical lesion that may advance to cancer. This improves the risk assessment for cervical cancer screening: on the one hand, unnecessary and overly-hasty surgeries can be avoided. On the other hand, the chance for early and successful treatment is improved. Patients also lose their anxiety about unclear results based on the current screening and instead gain fast certainty.

 

“We are very pleased that our concept of using epigenetic markers in cancer diagnostics together with the market potential of our first test GynTect convinced new investors to join oncgnostics. Their investment enables us to improve our market opportunities not only through enhanced international marketing, but also through further product developments”, Dr. Alfred Hansel, CEO of oncgnostics, says.

 

Past and future developments

The first steps for international marketing were made with an exclusive out-licensing of GynTect to a Chinese partner for the Chinese market as well as with first contracts for distributing the test in selected European countries (Portugal, Slovakia and the Czech Republic). Further strategic and distribution partnerships are now sought, especially for the US market, but also for additional European markets. In December 2017, the first patients were enrolled in a prospective clinical trial, with a three-year duration and across ten gynaecological practices and clinical centers, with the aim of further demonstrating the prognostic power of GynTect . Another trial investigating the psychological burden of women with abnormal Pap smear and/or positive HPV test results was recently completed, and its results are scheduled to be published by the end of this year.

 

Together with clinical partners, oncgnostics is developing diagnostic tests for other cancers. The Thuringian company is currently validating epigenetic markers for use in head and neck cancer, and it is also targeting tests that will help to improve timely detection of ovarian cancer.

 

About oncgnostics GmbH:

oncgnostics GmbH was founded 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 company´s tests demonstrate characteristic epigenetic changes in 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´s technological assets.

 

 

Free pictorial materials for dissemination may be found at: http://www.epitype.de/downloads

https://tinyurl.com/oncgnostics

https://vimeo.com/243256803

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Cervical Cancer and Uterine (Body) Cancer – What is the Difference?

Cervical CancerBlamb/Shutterstock.com

Although cervical cancer and uterine (body) cancer develop only a few centimetres apart, there are big differences in the cause of the disease. Therefore, the fields of research and treatment are also fundamentally different. This article will explain the differences, for a better understanding.

First, anatomy, in order to be able to better classify where both types of cancer originate: the uterus consists of the cervix, which ends at the lower end in the uterine orifice. The uterine body (corpus uteri) is connected to the upper end of the cervix. Cervical cancer develops in the cervix, only a few centimetres away from the uterus, where uterine (body) cancer develops.

Uterine Cancer – Factors, Occurrence and Symptoms

Uterine cancer (endometrial carcinoma, womb cancer, or corpus carcinoma) usually originates from the cells of the uterine mucosa. There is the very common oestrogen-dependent type I and the rare oestrogen-independent type II. Hereditary factors, overweight, diabetes and a long oestrogen influence (mostly caused by hormonal imbalances) favour uterine cancer. Uterine cancer usually occurs in older women. The average age is 69, and there is no regulated screening, as there is no cost-effective and reliable procedure for early detection.

While cervical cancer does not necessarily have symptoms, or they appear very late, uterine cancer usually has unusual bleeding at an early stage. If the patient goes to the doctor immediately and the bleeding is indeed a symptom of uterine cancer, there is a good chance of recovery. The uterus, fallopian tubes and ovaries may then be removed by surgery. If the cancer is more advanced, further treatment is necessary.

Cervical Cancer – Cause, Prevention, Treatment

Conditions are completely different in the case of cervical cancer: this disease develops over many years as a result of infection with certain strains of human papillomavirus (HPV). Through regular preventive care, preliminary stages, so-called dysplasias, can be detected and treated. Preliminary stages do not necessarily lead to the outbreak of cervical cancer. They may also regress. In any case, they must be observed. If a procedure is necessary, it is usually the so-called conisation, which aims at removing the carcinoma completely. As patients are often women of childbearing age, it is important to remove as little of the cervix as possible to avoid complications in possible later pregnancies.

Although cervical cancer (cervical carcinoma) and uterine cancer (endometrial carcinoma) develop only a few centimetres apart, they are two completely different types of cancer with different courses, symptoms and treatments. Particularly, cervical cancer is preventable: anyone who goes for regular cervical check and is vaccinated has a very low risk of developing it.

In summary, the following table provides an overview of both types of cancer:

 

Cervical cancer (cervical carcinoma) Uterine cancer (endometrial carcinoma)
Frequency 500.000 worldwide 382 069 worldwide
Average age of patients 34 (for early-stage carcinoma)

53 (for advanced carcinoma that has already spread to other tissue)

 69
Main cause/trigger Human papillomaviruses (HPV) Genetic factors, overweight, diabetes, hormonal imbalances
Symptoms Not necessarily. There may be pain during sexual intercourse, discharge or bleeding (in late stages) Bleeding (in early stages), other symptoms occur in later stages
Prevention HPV vaccination, screenings Healthy lifestyle
Early detection Organized screening, regulated by law No screening program. Examination (ultrasound or uterine endoscopy) can be performed as an individual health service (IGeL)
Duration of development Over a number of years
Treatment Observation and tests for preliminary stages, conisation for cancer (surgical procedure in which a conical piece of the cervix is removed) Surgical procedure (removal of the uterus, fallopian tubes and ovaries), additional treatment in case of advanced stages
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oncgnostics in China: Pitch, Trade Fair, and Meeting with Partner

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.

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Test for Uterine Cancer in Portugal: Biotech Firm oncgnostics Grants Exclusive Licence for Cancer Screening Test

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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.

 

 

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Reliable test for cervical cancer triage now available in Slovakia and the Czech Republic: Biotech company oncgnostics concludes an exclusive partnership with the MEDIREX group

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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

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GynTect soon available in China: – oncgnostics grants exclusive license for GynTect to the Chinese SINOPHARM subsidiary CJMT – approval for the Chinese market planned

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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 (http://www.epitype.de/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).

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