Tag Archive for: cancer

Cancer diagnostics of the future thanks to highly informative biomarkers

oncgnostics at Medica 2022:

Cervical cancer screening test conquers China
Establishing early detection of head and neck tumours
First study results for screening test for vulva and vaginal cancer
At the joint stand of medways e.V. in Hall 15, Stand K10

Jena / Düsseldorf, November 08, 2022 – oncgnostics GmbH will present its technology, products and current study results at the largest trade fair in the medical sector. The company is an expert in molecular cancer diagnostics. Life-saving early detection is possible with the cancer tests developed by oncgnostics, which are based on patented biomarks.

Cancer diagnostics through biotechnology

DNA methylations form the basis of oncgnostics’ work. Specific changes in the DNA methylation pattern occur when cancer develops or is already present. The tests from oncgnostics detect these changes.

Innovation in cervical cancer screening

GynTect is the company’s first product. Used in cervical cancer diagnostics, the test is already being marketed in several European countries. In August of this year, it was approved in China, where it is marketed under exclusive licence. It is the first methylation test for triage of HPV-positive cases on the Chinese market.

The methylation test in cervical cancer screening

A cervical smear, as it is also taken for thin-layer cytology or the HPV test, is sufficient for the procedure. The test is a decision-making aid on how best to proceed after an abnormal screening result. GynTect not only allows to detect whether a tumour is already present, but also detects cervical lesions that may develop into cervical cancer – years in advance. Thus, risk assessment is greatly facilitated: on the one hand, unnecessary, premature operations can be avoided, and on the other hand, the chance for early and thus promising therapeutic measures can be increased.

ScreenYu Gyn is a further development of GynTect. The diagnostic test, which was CE IVD-approved in May this year, uses only one methylated DNA region, whereas GynTect detects six methylated DNA regions (biomarkers). This makes it particularly well suited for automation. With a simplified and automated test version, countries and regions can be served in which cervical cancer screening has hardly taken place so far. Most new cases of cervical cancer and most deaths due to the disease occur in these countries.

Establish early detection for head and neck tumours

Head and neck tumours are among the five most common cancers worldwide. They often develop unnoticed for a long time because the symptoms are usually unspecific for those affected. So far, no early diagnosis has been established for this group of tumours. oncgnostics is developing a test to change this. In this test, DNA methylation markers identified in cancer tissue and validated by oncgnostics, are detected in the patient’s saliva. The test will initially be used in post-surgical follow-up, as tumour markers that already appear in the primary tumour are also detectable in re-emerging tumours.

Vulva and vaginal cancer: early detection also overdue

Early detection of vulvar and vaginal cancer is also difficult due to non-specific symptoms or no symptoms at all. Initial studies have confirmed that a methylation test with the same biomarkers as for cervical cancer may also be useful here. oncgnostics is continuing to work on diagnostics for the early detection of vulvar and vaginal cancer on this basis.

_____________________________________________

About oncgnostics GmbH:

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. oncgnostics GmbH is also conducting research into screening tests for other types of cancer. Detailed information is available at www.oncgnostics.com/en.

Free image material: www.oncgnostics.com/en/downloads

Contact:

oncgnostics GmbH

Löbstedter Str. 41

07749 Jena

Germany

Phone: +493641/5548550

pr(at)oncgnostics.com

www.oncgnostics.com

8. November 2022/by TowerPR

Third Generation Sequencing: Detecting cancer at DNA level

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Studio Beetz

Dr. Carolin Dippmann and Daria Meyer from our research and development team work, among other things, with the “third-generation sequencing” method. With the help of this technology, they are examining DNA (deoxyribonucleic acid) from tumors much more precisely than was previously possible.

The method has enormous advantages: epigenetic changes in the DNA, specifically DNA methylation in certain regions, tell us when healthy cells develop into cancer. And with “third generation sequencing” we can detect these changes directly.

Our goal at oncgnostics is to detect such epigenetic markers. Especially in the early detection of head and neck tumors, development is still in its infancy. In various research projects, including the OroCa-Graz study, we are working together with clinicians on a standardized screening to detect the associated diseases earlier and more reliably than before.

In the following, the two scientists explain to what extent third-generation sequencing is being used and what exactly is behind it.

How does Third Generation Sequencing work?

Part of our daily work is to screen DNA fragments for epigenetic changes, specifically DNA methylation. DNA methylation at specific base sequences indicates that the cell in question has changed.

Third generation sequencing is a method that makes these analyses faster and more effective. In addition, the method provides the DNA sequence information in very high resolution: namely, individual DNA molecules are analyzed. The biological DNA is transferred into a digital version and can be analyzed on the computer. DNA methylation, which occurs during cancer development, can be analyzed directly. And this is of particular interest to us.

The process is illustrated in a video from “Oxford Nanopore Technologies” on YouTube.

How does the method differ from previous methods?

With previous sequencing methods, we could only determine the base sequence of short DNA fragments (300 DNA bases on average). In addition, the DNA to be examined had to be copied several times in advance, very similar to the so-called PCR method explained here. In addition, the DNA had to be chemically treated to detect DNA methylation.

The Third Generation Sequencing method simplifies this process:

We can directly evaluate DNA molecules of up to several million DNA bases in length
No copies are necessary for this. Rather, we evaluate the individual DNA sequences directly
The speed with which we examine the sequences increases accordingly: We now collect the data in real time

What kind of data do we get?

The bottom line is that the Third Generation Sequencing method captures changes in current and records them digitally. It works like this: The DNA to be examined is placed on a surface that is under a specific voltage. Tiny pores made of proteins are embedded in this surface. During the process, the DNA migrates, always in the same direction, through these so-called nanopores. This is why the method is also called “Oxford Nanopore Technology” (ONT).

When the DNA migrates through a pore, the current intensity on the surface changes. This is due to the spatial arrangement and chemical properties of the DNA segments. Sensors measure these changes at each individual pore and transmit them to the computer connected to each. An algorithm then translates the information into the base sequence of the DNA. In the sequence recorded we also read the DNA methylation.

Are there any other advantages or disadvantages?

Since the method is still very new, it has a fairly high error rate. Currently, it recognizes only 95 percent of all sequences without errors. With other methods, the figure is 99.9 percent. Continuous developments will improve this over time. Daria Meyer’s work is part of this. She is a bioinformatician and, as part of her PhD thesis, she focuses on improving the algorithms that are essential for analyzing DNA methylation. In addition, we are constantly optimizing the process flows in the preparation of diagnostic samples. That is Carolin Dippmann’s focus in the project.

In fact, the advantages outweigh the disadvantages. One of the reasons for this is that the analyzer is barely larger than a USB stick and therefore super handy. Theoretically, sequencing can be carried out anywhere, from the Arctic to the desert.

What is our future benefit from Third Generation Sequencing?

With the help of ONT sequencing, major gaps in our knowledge of the human genome (the entire DNA sequence of a human being) have already been closed. We expect further developments in this area. And we are happy contribute to improving the technology.

The biggest advantage for us is the direct readability of epigenetic changes, i.e. DNA methylation. We can analyze these directly at our facility.

The method is gaining acceptance in more and more areas of application. This is not least due to the fact that the initial equipment for starting sequencing projects is very inexpensive. Sequencing of this quality is thus much more affordable. This means that small companies like oncgnostics can also utilize this technology.

31. January 2022/by TowerPR

Study „OroCa-Graz“ – Study on Head-and-Neck tumors: oncgnostics GmbH cooperates with the Medical University of Graz

Press Releases

Andrey_Popov/Shutterstock.com

The biotechnology company oncgnostics GmbH is researching a method for diagnosing Head-and-Neck tumors together with the clinical department for general ENT at the Medical University of Graz as part of the “OroCa-Graz” study. 550,000 people worldwide develop carcinomas of this type every year. As only advanced stages of tumours are often diagnosed, more than 300,000 of those affected die each year. The study aims to demonstrate that the diagnostic method developed for Head-and-Neck tumors and especially mouth and throat cancer (= oropharyngeal cancer) can reliably and early detect malignant tumors using non-invasive saliva samples.

Excessive alcohol and tobacco consumption are among the main risk factors for Head-and-Neck cancer. In addition, there has been an increase in cases of carcinoma in the mouth and throat area in recent years, in which infection with the human papillomavirus (HPV) was found. The rate of these HPV-associated cancers increases by 2.1 percent annually. Non-HPV-associated Head-and-Neck cancers decreased slightly by 0.4 percent over the same period[1]. In Germany, a current proportion of 40 percent of HPV-induced diseases is assumed, and the trend is rising[2].

The “OroCa-Graz” study is led by Prof. Dr. Dietmar Thurnher, Head of the General ENT Department at the Medical University of Graz. He explains: “Despite increasing cases, the treatment of Head-and-Neck cancer has not made any significant progress in the last 20 years. Beside new diseases, half of the patients return as so-called tumor recurrence within the two years after completing therapy. Furthermore, no early diagnosis has yet been established for Head-and-Neck tumors. Our goal is to change that. By examining the relationship between oropharyngeal carcinomas, HPV infections and DNA methylation markers, new ways of early diagnosis as well as secondary and tertiary prevention are emerging.”

Secondary prevention is aimed at people with an increased risk of disease, for example smokers. With preventive examinations, clarification as well as screening tests, malignant diseases, especially in risk groups, could be diagnosed at an early stage or abnormalities could be clarified. Until now, the throat is inspected when symptoms arise. Tertiary prevention measures are aimed at tumor patients who are in regular clinical follow-up after treatment.

“OroCa-Graz”: Course of study

As part of the “OroCa-Graz” study, tissue and saliva samples from patients with oropharyngeal cancer are examined comparatively. By submitting a simple saliva sample, complaints in the head and neck area should be clarified later. The detection of a malignant disease is carried out via the detection of tumor-specific DNA methylation markers, which were developed by oncgnostics. The HPV status of all samples is also determined. Based on these results, the scientists analyse how sensitive the tumor detection by the methylation markers is and whether there is a connection between the occurrence of the tumor markers and an HPV infection.

Additional saliva samples are taken during follow-up. The idea is that tumor markers that have already been detected in the primary tumor return in the development of recurrences. If the tumor markers are detected in the follow-up, action can be taken at an early stage.

Research on DNA methylation markers since 2012

Since its foundation in 2012, oncgnostics GmbH has been specifically engaged in the search for DNA methylation markers, including Head-and-neck tumors. So far, a set of potential tumor markers based on tissue and swab samples has been established for the disease. One of these tumor markers is already used in the diagnosis of cervical cancer in the GynTect® test.

“Changes in the DNA methylation pattern occur early in tumor development. By detecting our cancer-specific biomarkers, we can check, for example, if cancer precursors are present. In the future, the application could be a powerful tool for early detection in the context of cancer screening and as part of the follow-up examinations for oropharyngeal carcinomas,” said Dr. Martina Schmitz, CEO of oncgnostics GmbH.

[1] Universität Leipzig (2020): Oropharynxkarzinom: Gute Prognose – aber nicht für alle Patienten. Online available: https://www.quintessence-publishing.com/deu/de/news/nachrichten/bunte-welt/oropharynxkarzinom-gute-prognose-aber-nicht-fuer-alle-patienten

[2] Wagner S. et al. (2018): Das HPV-getriebene Oropharynxkarzinom – Inzidenz, Trends, Diagnose und Therapie. In: Der Urologe 57:1457–1463. Online available: https://pubmed.ncbi.nlm.nih.gov/28713770/

20. April 2021/by TowerPR

oncgnostics in China: Pitch, Trade Fair, and Meeting with Partner

Blog

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

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!

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.

18. April 2018/by TowerPR

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

Blog, Press Releases

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. 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 3^rd 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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16. April 2018/by TowerPR

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

Blog, Press Releases

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 5^th 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).

7. April 2017/by TowerPR

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